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Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atrovent Respimat (20 mcg)
COMBIVENT MDI (36/206 mcg)
Combivent Respimat (20 mcg/100 mcg)
Placebo via corresponding inhaler for blinding purposes
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Outpatients of either sex, 40 years or older, with a diagnosis of COPD (FEV1 65% predicted normal and FEV1/FVC 70%).

Exclusion Criteria:

Patients with significant diseases other than COPD that may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study, with a history of asthma or allergic rhinitis, who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy or using oral corticosteroid me dication at unstable doses (i.e., less than 6 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day will be excluded.

Sites / Locations

  • 1012.56.01006 Boehringer Ingelheim Investigational Site
  • 1012.56.01051 Boehringer Ingelheim Investigational Site
  • 1012.56.01071 Boehringer Ingelheim Investigational Site
  • 1012.56.01039 Boehringer Ingelheim Investigational Site
  • 1012.56.01012 Boehringer Ingelheim Investigational Site
  • 1012.56.01029 Boehringer Ingelheim Investigational Site
  • 1012.56.01043 Boehringer Ingelheim Investigational Site
  • 1012.56.01089 Boehringer Ingelheim Investigational Site
  • 1012.56.01021 Boehringer Ingelheim Investigational Site
  • 1012.56.01033 Boehringer Ingelheim Investigational Site
  • 1012.56.01020 Boehringer Ingelheim Investigational Site
  • 1012.56.01045 Boehringer Ingelheim Investigational Site
  • 1012.56.01040 Boehringer Ingelheim Investigational Site
  • 1012.56.01050 Boehringer Ingelheim Investigational Site
  • 1012.56.01018 Boehringer Ingelheim Investigational Site
  • 1012.56.01062 Boehringer Ingelheim Investigational Site
  • 1012.56.01036 Boehringer Ingelheim Investigational Site
  • 1012.56.01025 Boehringer Ingelheim Investigational Site
  • 1012.56.01088 Boehringer Ingelheim Investigational Site
  • 1012.56.01007 Boehringer Ingelheim Investigational Site
  • 1012.56.01058 Boehringer Ingelheim Investigational Site
  • 1012.56.01010 Boehringer Ingelheim Investigational Site
  • 1012.56.01065 Boehringer Ingelheim Investigational Site
  • 1012.56.01024 Boehringer Ingelheim Investigational Site
  • 1012.56.01001 Boehringer Ingelheim Investigational Site
  • 1012.56.01023 Boehringer Ingelheim Investigational Site
  • 1012.56.01052 Boehringer Ingelheim Investigational Site
  • 1012.56.01048 Boehringer Ingelheim Investigational Site
  • 1012.56.01093 Boehringer Ingelheim Investigational Site
  • 1012.56.01077 Boehringer Ingelheim Investigational Site
  • 1012.56.01083 Boehringer Ingelheim Investigational Site
  • 1012.56.01008 Boehringer Ingelheim Investigational Site
  • 1012.56.01019 Boehringer Ingelheim Investigational Site
  • 1012.56.01056 Boehringer Ingelheim Investigational Site
  • 1012.56.01066 Boehringer Ingelheim Investigational Site
  • 1012.56.01090 Boehringer Ingelheim Investigational Site
  • 1012.56.01054 Boehringer Ingelheim Investigational Site
  • 1012.56.01072 Boehringer Ingelheim Investigational Site
  • 1012.56.01070 Boehringer Ingelheim Investigational Site
  • 1012.56.01035 Boehringer Ingelheim Investigational Site
  • 1012.56.01079 Boehringer Ingelheim Investigational Site
  • 1012.56.01044 Boehringer Ingelheim Investigational Site
  • 1012.56.01076 Boehringer Ingelheim Investigational Site
  • 1012.56.01082 Boehringer Ingelheim Investigational Site
  • 1012.56.01049 Boehringer Ingelheim Investigational Site
  • 1012.56.01080 Boehringer Ingelheim Investigational Site
  • 1012.56.01027 Boehringer Ingelheim Investigational Site
  • 1012.56.01028 Boehringer Ingelheim Investigational Site
  • 1012.56.01069 Boehringer Ingelheim Investigational Site
  • 1012.56.01022 Boehringer Ingelheim Investigational Site
  • 1012.56.01015 Boehringer Ingelheim Investigational Site
  • 1012.56.01068 Boehringer Ingelheim Investigational Site
  • 1012.56.01078 Boehringer Ingelheim Investigational Site
  • 1012.56.01017 Boehringer Ingelheim Investigational Site
  • 1012.56.01042 Boehringer Ingelheim Investigational Site
  • 1012.56.01034 Boehringer Ingelheim Investigational Site
  • 1012.56.01031 Boehringer Ingelheim Investigational Site
  • 1012.56.01038 Boehringer Ingelheim Investigational Site
  • 1012.56.01016 Boehringer Ingelheim Investigational Site
  • 1012.56.01067 Boehringer Ingelheim Investigational Site
  • 1012.56.01003 Boehringer Ingelheim Investigational Site
  • 1012.56.01060 Boehringer Ingelheim Investigational Site
  • 1012.56.01004 Boehringer Ingelheim Investigational Site
  • 1012.56.01087 Boehringer Ingelheim Investigational Site
  • 1012.56.01057 Boehringer Ingelheim Investigational Site
  • 1012.56.01026 Boehringer Ingelheim Investigational Site
  • 1012.56.01037 Boehringer Ingelheim Investigational Site
  • 1012.56.01081 Boehringer Ingelheim Investigational Site
  • 1012.56.01085 Boehringer Ingelheim Investigational Site
  • 1012.56.01084 Boehringer Ingelheim Investigational Site
  • 1012.56.01011 Boehringer Ingelheim Investigational Site
  • 1012.56.01073 Boehringer Ingelheim Investigational Site
  • 1012.56.01075 Boehringer Ingelheim Investigational Site
  • 1012.56.01047 Boehringer Ingelheim Investigational Site
  • 1012.56.01014 Boehringer Ingelheim Investigational Site
  • 1012.56.01032 Boehringer Ingelheim Investigational Site
  • 1012.56.01002 Boehringer Ingelheim Investigational Site
  • 1012.56.01053 Boehringer Ingelheim Investigational Site
  • 1012.56.01009 Boehringer Ingelheim Investigational Site
  • 1012.56.01013 Boehringer Ingelheim Investigational Site
  • 1012.56.01059 Boehringer Ingelheim Investigational Site
  • 1012.56.01055 Boehringer Ingelheim Investigational Site
  • 1012.56.01063 Boehringer Ingelheim Investigational Site
  • 1012.56.01005 Boehringer Ingelheim Investigational Site
  • 1012.56.01064 Boehringer Ingelheim Investigational Site
  • 1012.56.01030 Boehringer Ingelheim Investigational Site
  • 1012.56.01074 Boehringer Ingelheim Investigational Site
  • 1012.56.54001 Centro Médico de la Dra. De Salvo
  • 1012.56.54002 Boehringer Ingelheim Investigational Site
  • 1012.56.54003 Policlínica Bancaria
  • 1012.56.54004 Hospital Ramos Mejia
  • 1012.56.54010 Instituto Lanari
  • 1012.56.54011 Boehringer Ingelheim Investigational Site
  • 1012.56.54015 Boehringer Ingelheim Investigational Site
  • 1012.56.54005 Instituto de Diagnóstico Cardiovascular La Plata
  • 1012.56.54012 Boehringer Ingelheim Investigational Site
  • 1012.56.54009 Instituto de Investigaciones Clínicas
  • 1012.56.54014 Boehringer Ingelheim Investigational Site
  • 1012.56.54007 CLINICA PRIVADA de MONTE GRANDE
  • 1012.56.54006 CENTRO PRIVADO de MEDICINA RESPIRATORIA
  • 1012.56.54008 HOSPITAL ITALIANO de ROSARIO
  • 1012.56.54013 Boehringer Ingelheim Investigational Site
  • 1012.56.3305A Centre hospitalier Germon & Gauthier
  • 1012.56.3303A Clinique de la Louvière
  • 1012.56.3301A Hôpital Ambroise Paré
  • 1012.56.3304A Centre Médical Erdre Saint Augustin
  • 1012.56.3302A Cabinet Médical
  • 1012.56.3302B Cabinet Médical
  • 1012.56.30001 Boehringer Ingelheim Investigational Site
  • 1012.56.30011 Boehringer Ingelheim Investigational Site
  • 1012.56.30013 Boehringer Ingelheim Investigational Site
  • 1012.56.30009 Boehringer Ingelheim Investigational Site
  • 1012.56.30007 Boehringer Ingelheim Investigational Site
  • 1012.56.30010 Boehringer Ingelheim Investigational Site
  • 1012.56.30002 Boehringer Ingelheim Investigational Site
  • 1012.56.30014 Boehringer Ingelheim Investigational Site
  • 1012.56.30003 Boehringer Ingelheim Investigational Site
  • 1012.56.82009 Boehringer Ingelheim Investigational Site
  • 1012.56.82010 Boehringer Ingelheim Investigational Site
  • 1012.56.82008 Boehringer Ingelheim Investigational Site
  • 1012.56.82001 Boehringer Ingelheim Investigational Site
  • 1012.56.82002 Boehringer Ingelheim Investigational Site
  • 1012.56.82005 Boehringer Ingelheim Investigational Site
  • 1012.56.82006 Boehringer Ingelheim Investigational Site
  • 1012.56.82007 Boehringer Ingelheim Investigational Site
  • 1012.56.64004 Boehringer Ingelheim Investigational Site
  • 1012.56.64001 Boehringer Ingelheim Investigational Site
  • 1012.56.64003 Boehringer Ingelheim Investigational Site
  • 1012.56.64006 Boehringer Ingelheim Investigational Site
  • 1012.56.64005 Boehringer Ingelheim Investigational Site
  • 1012.56.48009 Boehringer Ingelheim Investigational Site
  • 1012.56.48006 Boehringer Ingelheim Investigational Site
  • 1012.56.48007 Boehringer Ingelheim Investigational Site
  • 1012.56.48004 Boehringer Ingelheim Investigational Site
  • 1012.56.48005 Boehringer Ingelheim Investigational Site
  • 1012.56.48002 Boehringer Ingelheim Investigational Site
  • 1012.56.48010 Boehringer Ingelheim Investigational Site
  • 1012.56.48001 Boehringer Ingelheim Investigational Site
  • 1012.56.48011 Boehringer Ingelheim Investigational Site
  • 1012.56.48003 Boehringer Ingelheim Investigational Site
  • 1012.56.07010 Boehringer Ingelheim Investigational Site
  • 1012.56.07001 Boehringer Ingelheim Investigational Site
  • 1012.56.07002 Boehringer Ingelheim Investigational Site
  • 1012.56.07003 Boehringer Ingelheim Investigational Site
  • 1012.56.07005 Boehringer Ingelheim Investigational Site
  • 1012.56.07007 Boehringer Ingelheim Investigational Site
  • 1012.56.07008 Boehringer Ingelheim Investigational Site
  • 1012.56.07009 Boehringer Ingelheim Investigational Site
  • 1012.56.27002 Boehringer Ingelheim Investigational Site
  • 1012.56.27008 Boehringer Ingelheim Investigational Site
  • 1012.56.27001 Boehringer Ingelheim Investigational Site
  • 1012.56.27004 Boehringer Ingelheim Investigational Site
  • 1012.56.27005 Boehringer Ingelheim Investigational Site
  • 1012.56.27009 Boehringer Ingelheim Investigational Site
  • 1012.56.27003 Boehringer Ingelheim Investigational Site
  • 1012.56.27006 Boehringer Ingelheim Investigational Site
  • 1012.56.88604 Chang Gong Memorial Hospital
  • 1012.56.88605 Taichung Veterans General Hospital
  • 1012.56.88602 Taipei Veterans General Hospital
  • 1012.56.88603 National Taiwan University Hospital
  • 1012.56.88601 Chang Gung Memorial Hosp-Linkou
  • 1012.56.90001 Boehringer Ingelheim Investigational Site
  • 1012.56.90005 Boehringer Ingelheim Investigational Site
  • 1012.56.90003 Boehringer Ingelheim Investigational Site
  • 1012.56.90006 Boehringer Ingelheim Investigational Site
  • 1012.56.90002 Boehringer Ingelheim Investigational Site
  • 1012.56.38005 Boehringer Ingelheim Investigational Site
  • 1012.56.38006 Boehringer Ingelheim Investigational Site
  • 1012.56.38001 Boehringer Ingelheim Investigational Site
  • 1012.56.38002 Boehringer Ingelheim Investigational Site
  • 1012.56.38004 Boehringer Ingelheim Investigational Site
  • 1012.56.44009 Boehringer Ingelheim Investigational Site
  • 1012.56.44003 Boehringer Ingelheim Investigational Site
  • 1012.56.44002 Boehringer Ingelheim Investigational Site
  • 1012.56.44006 Colchester General Hospital
  • 1012.56.44007 Boehringer Ingelheim Investigational Site
  • 1012.56.44001 Medicine Evaluation Unit
  • 1012.56.44008 The Staploe Medical Centre
  • 1012.56.44005 Morriston Hospital
  • 1012.56.44010 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

COMBIVENT Respimat 20/100 mcg

COMBIVENT CFC-MDI 36/206 mcg

Ipratropium Respimat 20 mcg

Arm Description

Outcomes

Primary Outcome Measures

FEV1 AUC0-6 at Day 85
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85
FEV1 AUC0-4 at Day 85
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85
FEV1 AUC4-6 at Day 85
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85

Secondary Outcome Measures

FEV1 AUC0-6 at Day 1
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1
FEV1 AUC0-6 at Day 29
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29
FEV1 AUC0-6 at Day 57
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57
FEV1 AUC0-4 at Day 1
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1
FEV1 AUC0-4 at Day 29
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29
FEV1 AUC0-4 at Day 57
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57
FEV1 AUC4-6 at Day 1
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1
FEV1 AUC4-6 at Day 29
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29
FEV1 AUC4-6 at Day 57
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57
Peak FEV1 Response at Day 1
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1
Peak FEV1 Response at Day 29
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29
Peak FEV1 Response at Day 57
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57
Peak FEV1 Response at Day 85
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85
Time to Onset of Therapeutic FEV1 Response at Day 1
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 1
Time to Onset of Therapeutic FEV1 Response at Day 29
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 29
Time to Onset of Therapeutic FEV1 Response at Day 57
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 57
Time to Onset of Therapeutic FEV1 Response at Day 85
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 85
Duration of Therapeutic FEV1 Response at Day 1
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 1
Duration of Therapeutic FEV1 Response at Day 29
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 29
Duration of Therapeutic FEV1 Response at Day 57
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 57
Duration of Therapeutic FEV1 Response at Day 85
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 85
Time to Peak FEV1 Response at Day 1
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 1
Time to Peak FEV1 Response at Day 29
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 29
Time to Peak FEV1 Response at Day 57
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 57
Time to Peak FEV1 Response at Day 85
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 85
FVC AUC0-6 at Day 1
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1
FVC AUC0-6 at Day 29
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29
FVC AUC0-6 at Day 57
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57
FVC AUC0-6 at Day 85
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85
FVC AUC0-4 at Day 1
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1
FVC AUC0-4 at Day 29
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29
FVC AUC0-4 at Day 57
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57
FVC AUC0-4 at Day 85
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85
FVC AUC4-6 at Day 1
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1
FVC AUC4-6 at Day 29
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29
FVC AUC4-6 at Day 57
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57
FVC AUC4-6 at Day 85
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85
Peak FVC Response at Day 1
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1
Peak FVC Response at Day 29
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29
Peak FVC Response at Day 57
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57
Peak FVC Response at Day 85
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85
Rescue Medication Use on Pulmonary Test Day 1
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1
Rescue Medication Use on Pulmonary Test Day 29
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29
Rescue Medication Use on Pulmonary Test Day 57
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57
Rescue Medication Use on Pulmonary Test Day 85
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85
Night-time Rescue Medication Use
The mean number of puffs of rescue medication used during the night-time per week during the entire study (including baseline and on-treatment period)
Daytime Rescue Medication Use
The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period)
Night-time Symptom Score
The weekly mean night-time symptom score per week during the entire study (including baseline and on-treatment period). Night-time COPD symptoms: 0=none 1=some - slept well 2=woke once 3=woke several times 4=woke most of night
Daytime Symptom Score
The weekly mean daytime symptom score per week during the entire study (including baseline and on-treatment period). Daytime COPD symptoms: 0=none 1=occasional 2=frequent, no interference with activities 3=most of day, interference with activities 4=prevent working and activities
Trough Peak Expiratory Flow Rate (PEFR)
The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)
Physician's Global Evaluation Score on Pulmonary Function Testing Day 29
Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc. Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.
Physician's Global Evaluation Score on Pulmonary Function Testing Day 57
Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc. Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.
Physician's Global Evaluation Score on Pulmonary Function Testing Day 85
Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc. Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.
Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period
COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.
COPD Exacerbation Rate During the On-treatment Period
Proportion of patients experiencing a COPD exacerbation per patient year. COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.
COPD Exacerbation During the On-treatment Period
COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.
Frequency Distribution of Satisfaction Rating With Inhaler Attributes
Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Device Preference (Respimat or MDI)
Frequency of patients due to device preference
Rating of Action of Turning Clear Base of Respimat
Frequency of patients due to rating of action of turning clear base of Respimat
Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State
Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).
Noncompartmental Parameters of Albuterol at Steady State
Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).
Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours
Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-2, ss
Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours
Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0-2,ss.
Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours
Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-6,ss
Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours
Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0-6, ss

Full Information

First Posted
November 15, 2006
Last Updated
June 9, 2014
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00400153
Brief Title
Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Safety and Efficacy of Combivent Respimat in Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The primary objective of this study is to compare the effect of ipratropium bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20 mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20 mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at intervals over a treatment period of 12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat® to COMBIVENT® MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed. In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of therapy will be characterized in a subgroup of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COMBIVENT Respimat 20/100 mcg
Arm Type
Experimental
Arm Title
COMBIVENT CFC-MDI 36/206 mcg
Arm Type
Experimental
Arm Title
Ipratropium Respimat 20 mcg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Atrovent Respimat (20 mcg)
Intervention Type
Drug
Intervention Name(s)
COMBIVENT MDI (36/206 mcg)
Intervention Type
Drug
Intervention Name(s)
Combivent Respimat (20 mcg/100 mcg)
Intervention Type
Drug
Intervention Name(s)
Placebo via corresponding inhaler for blinding purposes
Primary Outcome Measure Information:
Title
FEV1 AUC0-6 at Day 85
Description
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85
Time Frame
Before drug administration to 6 hours after drug administration on Day 85
Title
FEV1 AUC0-4 at Day 85
Description
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85
Time Frame
Before drug administration to 4 hours after drug administration on Day 85
Title
FEV1 AUC4-6 at Day 85
Description
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85
Time Frame
Between 4 hours and 6 hours after drug administration on Day 85
Secondary Outcome Measure Information:
Title
FEV1 AUC0-6 at Day 1
Description
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1
Time Frame
Before drug administration to 6 hours after drug administration on Day 1
Title
FEV1 AUC0-6 at Day 29
Description
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29
Time Frame
Before drug administration to 6 hours after drug administration on Day 29
Title
FEV1 AUC0-6 at Day 57
Description
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57
Time Frame
Before drug administration to 6 hours after drug administration on Day 57
Title
FEV1 AUC0-4 at Day 1
Description
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1
Time Frame
Before drug administration to 4 hours after drug administration on Day 1
Title
FEV1 AUC0-4 at Day 29
Description
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29
Time Frame
Before drug administration to 4 hours after drug administration on Day 29
Title
FEV1 AUC0-4 at Day 57
Description
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57
Time Frame
Before drug administration to 4 hours after drug administration on Day 57
Title
FEV1 AUC4-6 at Day 1
Description
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1
Time Frame
Between 4 hours and 6 hours after drug administration on Day 1
Title
FEV1 AUC4-6 at Day 29
Description
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29
Time Frame
Between 4 hours and 6 hours after drug administration on Day 29
Title
FEV1 AUC4-6 at Day 57
Description
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57
Time Frame
Between 4 hours and 6 hours after drug administration on Day 57
Title
Peak FEV1 Response at Day 1
Description
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1
Time Frame
Within the first 2-hour post-treatment interval on Day 1
Title
Peak FEV1 Response at Day 29
Description
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29
Time Frame
Within the first 2-hour post-treatment interval on Day 29
Title
Peak FEV1 Response at Day 57
Description
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57
Time Frame
Within the first 2-hour post-treatment interval on Day 57
Title
Peak FEV1 Response at Day 85
Description
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85
Time Frame
Within the first 2-hour post-treatment interval on Day 85
Title
Time to Onset of Therapeutic FEV1 Response at Day 1
Description
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 1
Time Frame
Within the first 2-hour post-treatment interval at Day 1
Title
Time to Onset of Therapeutic FEV1 Response at Day 29
Description
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 29
Time Frame
Within the first 2-hour post-treatment interval at Day 29
Title
Time to Onset of Therapeutic FEV1 Response at Day 57
Description
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 57
Time Frame
Within the first 2-hour post-treatment interval at Day 57
Title
Time to Onset of Therapeutic FEV1 Response at Day 85
Description
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 85
Time Frame
Within the first 2-hour post-treatment interval at Day 85
Title
Duration of Therapeutic FEV1 Response at Day 1
Description
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 1
Time Frame
During the 6-hour observation period after drug administration at Day 1
Title
Duration of Therapeutic FEV1 Response at Day 29
Description
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 29
Time Frame
During the 6-hour observation period after drug administration at Day 29
Title
Duration of Therapeutic FEV1 Response at Day 57
Description
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 57
Time Frame
During the 6-hour observation period after drug administration at Day 57
Title
Duration of Therapeutic FEV1 Response at Day 85
Description
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 85
Time Frame
During the 6-hour observation period after drug administration at Day 85
Title
Time to Peak FEV1 Response at Day 1
Description
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 1
Time Frame
Within the 6-hour post-treatment observation period at Day 1
Title
Time to Peak FEV1 Response at Day 29
Description
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 29
Time Frame
Within the 6-hour post-treatment observation period at Day 29
Title
Time to Peak FEV1 Response at Day 57
Description
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 57
Time Frame
Within the 6-hour post-treatment observation period at Day 57
Title
Time to Peak FEV1 Response at Day 85
Description
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 85
Time Frame
Within the 6-hour post-treatment observation period at Day 85
Title
FVC AUC0-6 at Day 1
Description
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1
Time Frame
Before drug administration to 6 hours after drug administration at Day 1
Title
FVC AUC0-6 at Day 29
Description
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29
Time Frame
Before drug administration to 6 hours after drug administration at Day 29
Title
FVC AUC0-6 at Day 57
Description
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57
Time Frame
Before drug administration to 6 hours after drug administration on Day 57
Title
FVC AUC0-6 at Day 85
Description
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85
Time Frame
Before drug administration to 6 hours after drug administration on Day 85
Title
FVC AUC0-4 at Day 1
Description
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1
Time Frame
Before drug administration to 4 hours after drug administration on Day 1
Title
FVC AUC0-4 at Day 29
Description
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29
Time Frame
Before drug administration to 4 hours after drug administration on Day 29
Title
FVC AUC0-4 at Day 57
Description
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57
Time Frame
Before drug administration to 4 hours after drug administration on Day 57
Title
FVC AUC0-4 at Day 85
Description
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85
Time Frame
Before drug administration to 4 hours after drug administration on Day 85
Title
FVC AUC4-6 at Day 1
Description
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1
Time Frame
Between 4 hours and 6 hours after drug administration on Day 1
Title
FVC AUC4-6 at Day 29
Description
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29
Time Frame
Between 4 hours and 6 hours after drug administration on Day 29
Title
FVC AUC4-6 at Day 57
Description
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57
Time Frame
Between 4 hours and 6 hours after drug administration on Day 57
Title
FVC AUC4-6 at Day 85
Description
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85
Time Frame
Between 4 hours and 6 hours after drug administration on Day 85
Title
Peak FVC Response at Day 1
Description
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1
Time Frame
Within the first 2-hour post-treatment interval at Day 1
Title
Peak FVC Response at Day 29
Description
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29
Time Frame
Within the first 2-hour post-treatment interval at Day 29
Title
Peak FVC Response at Day 57
Description
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57
Time Frame
Within the first 2-hour post-treatment interval at Day 57
Title
Peak FVC Response at Day 85
Description
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85
Time Frame
Within the first 2-hour post-treatment interval at Day 85
Title
Rescue Medication Use on Pulmonary Test Day 1
Description
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1
Time Frame
During the 6-hour pulmonary function testing after drug administration on Day 1
Title
Rescue Medication Use on Pulmonary Test Day 29
Description
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29
Time Frame
During the 6-hour pulmonary function testing after drug administration on Day 29
Title
Rescue Medication Use on Pulmonary Test Day 57
Description
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57
Time Frame
During the 6-hour pulmonary function testing after drug administration on Day 57
Title
Rescue Medication Use on Pulmonary Test Day 85
Description
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85
Time Frame
During the 6-hour pulmonary function testing after drug administration on Day 85
Title
Night-time Rescue Medication Use
Description
The mean number of puffs of rescue medication used during the night-time per week during the entire study (including baseline and on-treatment period)
Time Frame
During the 2-week baseline washout period and the 12-week treatment period
Title
Daytime Rescue Medication Use
Description
The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period)
Time Frame
During the 2-week baseline washout period and the 12-week treatment period
Title
Night-time Symptom Score
Description
The weekly mean night-time symptom score per week during the entire study (including baseline and on-treatment period). Night-time COPD symptoms: 0=none 1=some - slept well 2=woke once 3=woke several times 4=woke most of night
Time Frame
During the 2-week baseline washout period and the 12-week treatment period
Title
Daytime Symptom Score
Description
The weekly mean daytime symptom score per week during the entire study (including baseline and on-treatment period). Daytime COPD symptoms: 0=none 1=occasional 2=frequent, no interference with activities 3=most of day, interference with activities 4=prevent working and activities
Time Frame
During the 2-week baseline washout period and the 12-week treatment period
Title
Trough Peak Expiratory Flow Rate (PEFR)
Description
The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)
Time Frame
During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication
Title
Physician's Global Evaluation Score on Pulmonary Function Testing Day 29
Description
Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc. Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.
Time Frame
Prior to pulmonary function test on Day 29
Title
Physician's Global Evaluation Score on Pulmonary Function Testing Day 57
Description
Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc. Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.
Time Frame
Prior to pulmonary function test on Day 57
Title
Physician's Global Evaluation Score on Pulmonary Function Testing Day 85
Description
Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc. Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.
Time Frame
Prior to pulmonary function test on Day 85
Title
Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period
Description
COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.
Time Frame
During the 12-week on-treatment period
Title
COPD Exacerbation Rate During the On-treatment Period
Description
Proportion of patients experiencing a COPD exacerbation per patient year. COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.
Time Frame
During the 12-week on-treatment period
Title
COPD Exacerbation During the On-treatment Period
Description
COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.
Time Frame
During the 12-week on-treatment period
Title
Frequency Distribution of Satisfaction Rating With Inhaler Attributes
Time Frame
12 weeks
Title
Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine
Description
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Time Frame
12 weeks
Title
Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung
Description
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Time Frame
12 weeks
Title
Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left
Description
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Time Frame
12 weeks
Title
Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably
Description
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Time Frame
12 weeks
Title
Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler
Description
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Time Frame
12 weeks
Title
Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use
Description
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Time Frame
12 weeks
Title
Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable
Description
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Time Frame
12 weeks
Title
Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler
Description
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Time Frame
12 weeks
Title
Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler
Description
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Time Frame
12 weeks
Title
Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler
Description
Patients rated their response on a seven point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
Time Frame
12 weeks
Title
Device Preference (Respimat or MDI)
Description
Frequency of patients due to device preference
Time Frame
12 weeks
Title
Rating of Action of Turning Clear Base of Respimat
Description
Frequency of patients due to rating of action of turning clear base of Respimat
Time Frame
12 weeks
Title
Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State
Description
Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).
Time Frame
Before drug administration to 6 hours after drug administration on Day 29
Title
Noncompartmental Parameters of Albuterol at Steady State
Description
Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).
Time Frame
Before drug administration to 6 hours after drug administration on Day 29
Title
Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours
Description
Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-2, ss
Time Frame
Before drug administration to 2 hours after drug administration on Day 29
Title
Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours
Description
Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0-2,ss.
Time Frame
Before drug administration to 2 hours after drug administration on Day 29
Title
Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours
Description
Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-6,ss
Time Frame
Before drug administration to 6 hours after drug administration on Day 26
Title
Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours
Description
Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0-6, ss
Time Frame
Before drug administration to 6 hours after drug administration on Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatients of either sex, 40 years or older, with a diagnosis of COPD (FEV1 65% predicted normal and FEV1/FVC 70%). Exclusion Criteria: Patients with significant diseases other than COPD that may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study, with a history of asthma or allergic rhinitis, who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy or using oral corticosteroid me dication at unstable doses (i.e., less than 6 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1012.56.01006 Boehringer Ingelheim Investigational Site
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
1012.56.01051 Boehringer Ingelheim Investigational Site
City
Jasper
State/Province
Alabama
Country
United States
Facility Name
1012.56.01071 Boehringer Ingelheim Investigational Site
City
Mobile
State/Province
Alabama
Country
United States
Facility Name
1012.56.01039 Boehringer Ingelheim Investigational Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
1012.56.01012 Boehringer Ingelheim Investigational Site
City
Lakewood
State/Province
California
Country
United States
Facility Name
1012.56.01029 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1012.56.01043 Boehringer Ingelheim Investigational Site
City
Palo Alto
State/Province
California
Country
United States
Facility Name
1012.56.01089 Boehringer Ingelheim Investigational Site
City
Rancho Mirage
State/Province
California
Country
United States
Facility Name
1012.56.01021 Boehringer Ingelheim Investigational Site
City
Riverside
State/Province
California
Country
United States
Facility Name
1012.56.01033 Boehringer Ingelheim Investigational Site
City
San Jose
State/Province
California
Country
United States
Facility Name
1012.56.01020 Boehringer Ingelheim Investigational Site
City
Sepulveda
State/Province
California
Country
United States
Facility Name
1012.56.01045 Boehringer Ingelheim Investigational Site
City
Torrence
State/Province
California
Country
United States
Facility Name
1012.56.01040 Boehringer Ingelheim Investigational Site
City
Denver
State/Province
Colorado
Country
United States
Facility Name
1012.56.01050 Boehringer Ingelheim Investigational Site
City
Fort Collins
State/Province
Colorado
Country
United States
Facility Name
1012.56.01018 Boehringer Ingelheim Investigational Site
City
Wheat Ridge
State/Province
Colorado
Country
United States
Facility Name
1012.56.01062 Boehringer Ingelheim Investigational Site
City
Wheat Ridge
State/Province
Colorado
Country
United States
Facility Name
1012.56.01036 Boehringer Ingelheim Investigational Site
City
Hartford
State/Province
Connecticut
Country
United States
Facility Name
1012.56.01025 Boehringer Ingelheim Investigational Site
City
Stamford
State/Province
Connecticut
Country
United States
Facility Name
1012.56.01088 Boehringer Ingelheim Investigational Site
City
Waterbury
State/Province
Connecticut
Country
United States
Facility Name
1012.56.01007 Boehringer Ingelheim Investigational Site
City
Bay Pines
State/Province
Florida
Country
United States
Facility Name
1012.56.01058 Boehringer Ingelheim Investigational Site
City
Brandon
State/Province
Florida
Country
United States
Facility Name
1012.56.01010 Boehringer Ingelheim Investigational Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
1012.56.01065 Boehringer Ingelheim Investigational Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
1012.56.01024 Boehringer Ingelheim Investigational Site
City
Deland
State/Province
Florida
Country
United States
Facility Name
1012.56.01001 Boehringer Ingelheim Investigational Site
City
Melbourne
State/Province
Florida
Country
United States
Facility Name
1012.56.01023 Boehringer Ingelheim Investigational Site
City
Panama City
State/Province
Florida
Country
United States
Facility Name
1012.56.01052 Boehringer Ingelheim Investigational Site
City
Pensecola
State/Province
Florida
Country
United States
Facility Name
1012.56.01048 Boehringer Ingelheim Investigational Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
1012.56.01093 Boehringer Ingelheim Investigational Site
City
Winter Park
State/Province
Florida
Country
United States
Facility Name
1012.56.01077 Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
1012.56.01083 Boehringer Ingelheim Investigational Site
City
Decatur
State/Province
Georgia
Country
United States
Facility Name
1012.56.01008 Boehringer Ingelheim Investigational Site
City
Coeur D'Alene
State/Province
Idaho
Country
United States
Facility Name
1012.56.01019 Boehringer Ingelheim Investigational Site
City
Olathe
State/Province
Kansas
Country
United States
Facility Name
1012.56.01056 Boehringer Ingelheim Investigational Site
City
Wichita
State/Province
Kansas
Country
United States
Facility Name
1012.56.01066 Boehringer Ingelheim Investigational Site
City
Bowling Green
State/Province
Kentucky
Country
United States
Facility Name
1012.56.01090 Boehringer Ingelheim Investigational Site
City
Lafayette
State/Province
Louisiana
Country
United States
Facility Name
1012.56.01054 Boehringer Ingelheim Investigational Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
1012.56.01072 Boehringer Ingelheim Investigational Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
1012.56.01070 Boehringer Ingelheim Investigational Site
City
Shreveport
State/Province
Louisiana
Country
United States
Facility Name
1012.56.01035 Boehringer Ingelheim Investigational Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
1012.56.01079 Boehringer Ingelheim Investigational Site
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
1012.56.01044 Boehringer Ingelheim Investigational Site
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
1012.56.01076 Boehringer Ingelheim Investigational Site
City
St. Louis
State/Province
Missouri
Country
United States
Facility Name
1012.56.01082 Boehringer Ingelheim Investigational Site
City
Henderson
State/Province
Nevada
Country
United States
Facility Name
1012.56.01049 Boehringer Ingelheim Investigational Site
City
Reno
State/Province
Nevada
Country
United States
Facility Name
1012.56.01080 Boehringer Ingelheim Investigational Site
City
Brick
State/Province
New Jersey
Country
United States
Facility Name
1012.56.01027 Boehringer Ingelheim Investigational Site
City
Cherry Hill
State/Province
New Jersey
Country
United States
Facility Name
1012.56.01028 Boehringer Ingelheim Investigational Site
City
Summit
State/Province
New Jersey
Country
United States
Facility Name
1012.56.01069 Boehringer Ingelheim Investigational Site
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
1012.56.01022 Boehringer Ingelheim Investigational Site
City
Larchmont
State/Province
New York
Country
United States
Facility Name
1012.56.01015 Boehringer Ingelheim Investigational Site
City
New Hyde Park
State/Province
New York
Country
United States
Facility Name
1012.56.01068 Boehringer Ingelheim Investigational Site
City
New York City
State/Province
New York
Country
United States
Facility Name
1012.56.01078 Boehringer Ingelheim Investigational Site
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
1012.56.01017 Boehringer Ingelheim Investigational Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
1012.56.01042 Boehringer Ingelheim Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
1012.56.01034 Boehringer Ingelheim Investigational Site
City
Sylvania
State/Province
Ohio
Country
United States
Facility Name
1012.56.01031 Boehringer Ingelheim Investigational Site
City
Toledo
State/Province
Ohio
Country
United States
Facility Name
1012.56.01038 Boehringer Ingelheim Investigational Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
1012.56.01016 Boehringer Ingelheim Investigational Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
1012.56.01067 Boehringer Ingelheim Investigational Site
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
1012.56.01003 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
1012.56.01060 Boehringer Ingelheim Investigational Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
1012.56.01004 Boehringer Ingelheim Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
1012.56.01087 Boehringer Ingelheim Investigational Site
City
East Providence
State/Province
Rhode Island
Country
United States
Facility Name
1012.56.01057 Boehringer Ingelheim Investigational Site
City
Johnston
State/Province
Rhode Island
Country
United States
Facility Name
1012.56.01026 Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
1012.56.01037 Boehringer Ingelheim Investigational Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
1012.56.01081 Boehringer Ingelheim Investigational Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
1012.56.01085 Boehringer Ingelheim Investigational Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
1012.56.01084 Boehringer Ingelheim Investigational Site
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
1012.56.01011 Boehringer Ingelheim Investigational Site
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
1012.56.01073 Boehringer Ingelheim Investigational Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
1012.56.01075 Boehringer Ingelheim Investigational Site
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
1012.56.01047 Boehringer Ingelheim Investigational Site
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
1012.56.01014 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1012.56.01032 Boehringer Ingelheim Investigational Site
City
Killeen
State/Province
Texas
Country
United States
Facility Name
1012.56.01002 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1012.56.01053 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1012.56.01009 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
1012.56.01013 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
1012.56.01059 Boehringer Ingelheim Investigational Site
City
Roanoke
State/Province
Virginia
Country
United States
Facility Name
1012.56.01055 Boehringer Ingelheim Investigational Site
City
Salem
State/Province
Virginia
Country
United States
Facility Name
1012.56.01063 Boehringer Ingelheim Investigational Site
City
Bellington
State/Province
Washington
Country
United States
Facility Name
1012.56.01005 Boehringer Ingelheim Investigational Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
1012.56.01064 Boehringer Ingelheim Investigational Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
1012.56.01030 Boehringer Ingelheim Investigational Site
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
1012.56.01074 Boehringer Ingelheim Investigational Site
City
Morgantown
State/Province
West Virginia
Country
United States
Facility Name
1012.56.54001 Centro Médico de la Dra. De Salvo
City
Capital Federal
Country
Argentina
Facility Name
1012.56.54002 Boehringer Ingelheim Investigational Site
City
Capital Federal
Country
Argentina
Facility Name
1012.56.54003 Policlínica Bancaria
City
Capital Federal
Country
Argentina
Facility Name
1012.56.54004 Hospital Ramos Mejia
City
Capital Federal
Country
Argentina
Facility Name
1012.56.54010 Instituto Lanari
City
Capital Federal
Country
Argentina
Facility Name
1012.56.54011 Boehringer Ingelheim Investigational Site
City
Capital Federal
Country
Argentina
Facility Name
1012.56.54015 Boehringer Ingelheim Investigational Site
City
Capital Federal
Country
Argentina
Facility Name
1012.56.54005 Instituto de Diagnóstico Cardiovascular La Plata
City
La Plata
Country
Argentina
Facility Name
1012.56.54012 Boehringer Ingelheim Investigational Site
City
Lanús
Country
Argentina
Facility Name
1012.56.54009 Instituto de Investigaciones Clínicas
City
Mar del Plata
Country
Argentina
Facility Name
1012.56.54014 Boehringer Ingelheim Investigational Site
City
Mendoza
Country
Argentina
Facility Name
1012.56.54007 CLINICA PRIVADA de MONTE GRANDE
City
Monte Grande
Country
Argentina
Facility Name
1012.56.54006 CENTRO PRIVADO de MEDICINA RESPIRATORIA
City
Paraná
Country
Argentina
Facility Name
1012.56.54008 HOSPITAL ITALIANO de ROSARIO
City
Rosario
Country
Argentina
Facility Name
1012.56.54013 Boehringer Ingelheim Investigational Site
City
San Miguel de Tucumán
Country
Argentina
Facility Name
1012.56.3305A Centre hospitalier Germon & Gauthier
City
Béthune
Country
France
Facility Name
1012.56.3303A Clinique de la Louvière
City
Lille Cedex
Country
France
Facility Name
1012.56.3301A Hôpital Ambroise Paré
City
Marseille
Country
France
Facility Name
1012.56.3304A Centre Médical Erdre Saint Augustin
City
Nantes
Country
France
Facility Name
1012.56.3302A Cabinet Médical
City
Nice
Country
France
Facility Name
1012.56.3302B Cabinet Médical
City
Nice
Country
France
Facility Name
1012.56.30001 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1012.56.30011 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1012.56.30013 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1012.56.30009 Boehringer Ingelheim Investigational Site
City
Heraklion
Country
Greece
Facility Name
1012.56.30007 Boehringer Ingelheim Investigational Site
City
Komotini
Country
Greece
Facility Name
1012.56.30010 Boehringer Ingelheim Investigational Site
City
Korinthos
Country
Greece
Facility Name
1012.56.30002 Boehringer Ingelheim Investigational Site
City
Larissa
Country
Greece
Facility Name
1012.56.30014 Boehringer Ingelheim Investigational Site
City
Nafplio
Country
Greece
Facility Name
1012.56.30003 Boehringer Ingelheim Investigational Site
City
Thessaloniki
Country
Greece
Facility Name
1012.56.82009 Boehringer Ingelheim Investigational Site
City
Daegu
Country
Korea, Republic of
Facility Name
1012.56.82010 Boehringer Ingelheim Investigational Site
City
Geonggi-Do
Country
Korea, Republic of
Facility Name
1012.56.82008 Boehringer Ingelheim Investigational Site
City
Gyeonggi-Do
Country
Korea, Republic of
Facility Name
1012.56.82001 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1012.56.82002 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1012.56.82005 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1012.56.82006 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1012.56.82007 Boehringer Ingelheim Investigational Site
City
Seoul
Country
Korea, Republic of
Facility Name
1012.56.64004 Boehringer Ingelheim Investigational Site
City
Dunedin
Country
New Zealand
Facility Name
1012.56.64001 Boehringer Ingelheim Investigational Site
City
Grafton / Auckland
Country
New Zealand
Facility Name
1012.56.64003 Boehringer Ingelheim Investigational Site
City
Hamilton
Country
New Zealand
Facility Name
1012.56.64006 Boehringer Ingelheim Investigational Site
City
Tauranga
Country
New Zealand
Facility Name
1012.56.64005 Boehringer Ingelheim Investigational Site
City
Wellington
Country
New Zealand
Facility Name
1012.56.48009 Boehringer Ingelheim Investigational Site
City
Bydgoszcz
Country
Poland
Facility Name
1012.56.48006 Boehringer Ingelheim Investigational Site
City
Krakow
Country
Poland
Facility Name
1012.56.48007 Boehringer Ingelheim Investigational Site
City
Krakow
Country
Poland
Facility Name
1012.56.48004 Boehringer Ingelheim Investigational Site
City
Ostrow Wielkopolska
Country
Poland
Facility Name
1012.56.48005 Boehringer Ingelheim Investigational Site
City
Poznan
Country
Poland
Facility Name
1012.56.48002 Boehringer Ingelheim Investigational Site
City
Proszowice
Country
Poland
Facility Name
1012.56.48010 Boehringer Ingelheim Investigational Site
City
Radom
Country
Poland
Facility Name
1012.56.48001 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1012.56.48011 Boehringer Ingelheim Investigational Site
City
Warsaw
Country
Poland
Facility Name
1012.56.48003 Boehringer Ingelheim Investigational Site
City
Wroclaw
Country
Poland
Facility Name
1012.56.07010 Boehringer Ingelheim Investigational Site
City
Kazan
Country
Russian Federation
Facility Name
1012.56.07001 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1012.56.07002 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1012.56.07003 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1012.56.07005 Boehringer Ingelheim Investigational Site
City
Moscow
Country
Russian Federation
Facility Name
1012.56.07007 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1012.56.07008 Boehringer Ingelheim Investigational Site
City
St. Petersburg
Country
Russian Federation
Facility Name
1012.56.07009 Boehringer Ingelheim Investigational Site
City
St.Petersburg
Country
Russian Federation
Facility Name
1012.56.27002 Boehringer Ingelheim Investigational Site
City
Bellville
Country
South Africa
Facility Name
1012.56.27008 Boehringer Ingelheim Investigational Site
City
Boksburg
Country
South Africa
Facility Name
1012.56.27001 Boehringer Ingelheim Investigational Site
City
Cape Town
Country
South Africa
Facility Name
1012.56.27004 Boehringer Ingelheim Investigational Site
City
Cape Town
Country
South Africa
Facility Name
1012.56.27005 Boehringer Ingelheim Investigational Site
City
Johannesburg
Country
South Africa
Facility Name
1012.56.27009 Boehringer Ingelheim Investigational Site
City
Orange Grove
Country
South Africa
Facility Name
1012.56.27003 Boehringer Ingelheim Investigational Site
City
Paarl
Country
South Africa
Facility Name
1012.56.27006 Boehringer Ingelheim Investigational Site
City
Park Town West
Country
South Africa
Facility Name
1012.56.88604 Chang Gong Memorial Hospital
City
Keelong Town
Country
Taiwan
Facility Name
1012.56.88605 Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
1012.56.88602 Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
1012.56.88603 National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
1012.56.88601 Chang Gung Memorial Hosp-Linkou
City
Taoyuan
Country
Taiwan
Facility Name
1012.56.90001 Boehringer Ingelheim Investigational Site
City
Ankara
Country
Turkey
Facility Name
1012.56.90005 Boehringer Ingelheim Investigational Site
City
Antalya
Country
Turkey
Facility Name
1012.56.90003 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1012.56.90006 Boehringer Ingelheim Investigational Site
City
Istanbul
Country
Turkey
Facility Name
1012.56.90002 Boehringer Ingelheim Investigational Site
City
Mersin
Country
Turkey
Facility Name
1012.56.38005 Boehringer Ingelheim Investigational Site
City
Dnyepropyetrovsk
Country
Ukraine
Facility Name
1012.56.38006 Boehringer Ingelheim Investigational Site
City
Donetsk
Country
Ukraine
Facility Name
1012.56.38001 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
1012.56.38002 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
1012.56.38004 Boehringer Ingelheim Investigational Site
City
Kiev
Country
Ukraine
Facility Name
1012.56.44009 Boehringer Ingelheim Investigational Site
City
Ballieston, Glasgow
Country
United Kingdom
Facility Name
1012.56.44003 Boehringer Ingelheim Investigational Site
City
Bury St Edmonds
Country
United Kingdom
Facility Name
1012.56.44002 Boehringer Ingelheim Investigational Site
City
Cambridge
Country
United Kingdom
Facility Name
1012.56.44006 Colchester General Hospital
City
Colchester
Country
United Kingdom
Facility Name
1012.56.44007 Boehringer Ingelheim Investigational Site
City
Doncaster
Country
United Kingdom
Facility Name
1012.56.44001 Medicine Evaluation Unit
City
Manchester
Country
United Kingdom
Facility Name
1012.56.44008 The Staploe Medical Centre
City
Soham
Country
United Kingdom
Facility Name
1012.56.44005 Morriston Hospital
City
Swansea
Country
United Kingdom
Facility Name
1012.56.44010 Boehringer Ingelheim Investigational Site
City
Windsor
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20172704
Citation
Zuwallack R, De Salvo MC, Kaelin T, Bateman ED, Park CS, Abrahams R, Fakih F, Sachs P, Pudi K, Zhao Y, Wood CC; Combivent Respimat Inhaler Study Group. Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler versus MDI. Respir Med. 2010 Aug;104(8):1179-88. doi: 10.1016/j.rmed.2010.01.017. Epub 2010 Feb 20.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1012/1012.56_U08-3368.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/1012/1012.56_literature.pdf
Description
Related Info

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