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Effects of Once Daily Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD) of Different Severity

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Tiotropium bromide
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
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: All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable, mild to severe airway obstruction with an FEV1 =<70% of predicted normal and an FEV1/FVC < 70 %. Predicted normal values will be taken from the print-outs of the spirometers. Spirometers have to calibrated according to ECCS. Male or female patients 40 years of age or older. Patients must be current or ex-smokers with a smoking history of 10 or more than 10 pack-years. Pack Years = Number of cigarettes/day : 20 x years of smoking (Patients who have never smoked cigarettes must not be included) Patients must be able to perform all study related tests, acceptable pulmonary function tests, including Peak Expiratory Flow Rate (PEFR) measurements, and must be able to maintain diary cards during the study period as required in the protocol. Patients must be able to inhale medication from the HandiHaler. All patients must sign an Informed Consent Form prior to participation in the trial i.e. prior to pre-study washout of their usual pulmonary medications. Exclusion Criteria: Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator 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. Patients with a recent history (i.e., one year or less) of myocardial infarction. Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past three years. Patients 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. Patients with known active tuberculosis. Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion 1. Patients with any respiratory infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period. Patients who are currently in a pulmonary rehabilitation programme or who have completed a pulmonary rehabilitation programme in the six week prior to the Screening Visit (Visit 1). Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system. Patients with known symptomatic prostate hypertrophy or bladder neck obstruction. Patients with known narrow-angle glaucoma. Patients using oral corticosteroid medication at unstable doses (i.e., less than four weeks on a stable dose before Visit 1) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm or subdermal implants). Patients with a history of asthma, allergic rhinitis or atopy. Patients with a history of and/or active significant alcohol or drug abuse. Patients who have taken an investigational drug within one month prior to Screening Visit (Visit 1). A log of all subjects screened, and reasons for exclusion for those not randomised will be maintained.

Sites / Locations

  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • MEDARS GmbH
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Johannes-Gutenberg-Universität Mainz
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

Change from baseline in trough FEV1 (Forced expiratory volume in one second)
Change from baseline in FEV1 2 hours post inhalation

Secondary Outcome Measures

Change from baseline in FEV1 2 hours post inhalation
Change from baseline in FVC (Forced Vital Capacity) 2 hours post inhalation
Change from baseline in IVC (Inspiratory Vital Capacity) 2 hours post inhalation
Number of patients having a COPD exacerbation
Number of patients being hospitalised due to a COPD exacerbation
Number of COPD exacerbations per patient
Number hospitalisations due to COPD exacerbations per patient
Duration of COPD exacerbations per patient
Duration of hospitalisations due to a COPD exacerbation

Full Information

First Posted
January 9, 2006
Last Updated
November 20, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00274573
Brief Title
Effects of Once Daily Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD) of Different Severity
Official Title
Acute and Long-term Effects of Once Daily Oral Inhalation of Tiotropium 18 Mcg Dry Powder Inhalation Capsules in a Placebo Controlled Parallel Group Design Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) of Different Severity
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
October 2002 (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 investigate the effect of tiotropium vs. placebo on trough FEV1 and FEV1 2 hours post inhalation after 12 weeks of treatment. For both endpoints changes from baseline will be analysed. Three strata of patients will be included (severe COPD, i.e. <35% of predicted FEV1, moderate COPD, i.e. 35% - <50% of predicted FEV1, mild COPD, i.e. 50% - 70% of predicted FEV1, according to American Thoracic Society [ATS] criteria). The study is conducted in order to find out for which endpoint tiotropium is different from placebo in which stratum.

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
1639 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tiotropium bromide
Primary Outcome Measure Information:
Title
Change from baseline in trough FEV1 (Forced expiratory volume in one second)
Time Frame
after 12 weeks
Title
Change from baseline in FEV1 2 hours post inhalation
Time Frame
after 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in FEV1 2 hours post inhalation
Time Frame
Day 1
Title
Change from baseline in FVC (Forced Vital Capacity) 2 hours post inhalation
Time Frame
Day 1 and 85
Title
Change from baseline in IVC (Inspiratory Vital Capacity) 2 hours post inhalation
Time Frame
Day 1 and 85
Title
Number of patients having a COPD exacerbation
Time Frame
12 weeks
Title
Number of patients being hospitalised due to a COPD exacerbation
Time Frame
12 weeks
Title
Number of COPD exacerbations per patient
Time Frame
12 weeks
Title
Number hospitalisations due to COPD exacerbations per patient
Time Frame
12 weeks
Title
Duration of COPD exacerbations per patient
Time Frame
12 weeks
Title
Duration of hospitalisations due to a COPD exacerbation
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable, mild to severe airway obstruction with an FEV1 =<70% of predicted normal and an FEV1/FVC < 70 %. Predicted normal values will be taken from the print-outs of the spirometers. Spirometers have to calibrated according to ECCS. Male or female patients 40 years of age or older. Patients must be current or ex-smokers with a smoking history of 10 or more than 10 pack-years. Pack Years = Number of cigarettes/day : 20 x years of smoking (Patients who have never smoked cigarettes must not be included) Patients must be able to perform all study related tests, acceptable pulmonary function tests, including Peak Expiratory Flow Rate (PEFR) measurements, and must be able to maintain diary cards during the study period as required in the protocol. Patients must be able to inhale medication from the HandiHaler. All patients must sign an Informed Consent Form prior to participation in the trial i.e. prior to pre-study washout of their usual pulmonary medications. Exclusion Criteria: Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator 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. Patients with a recent history (i.e., one year or less) of myocardial infarction. Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past three years. Patients 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. Patients with known active tuberculosis. Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion 1. Patients with any respiratory infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period. Patients who are currently in a pulmonary rehabilitation programme or who have completed a pulmonary rehabilitation programme in the six week prior to the Screening Visit (Visit 1). Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system. Patients with known symptomatic prostate hypertrophy or bladder neck obstruction. Patients with known narrow-angle glaucoma. Patients using oral corticosteroid medication at unstable doses (i.e., less than four weeks on a stable dose before Visit 1) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm or subdermal implants). Patients with a history of asthma, allergic rhinitis or atopy. Patients with a history of and/or active significant alcohol or drug abuse. Patients who have taken an investigational drug within one month prior to Screening Visit (Visit 1). A log of all subjects screened, and reasons for exclusion for those not randomised will be maintained.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
Boehringer Ingelheim KG
Official's Role
Study Chair
Facility Information:
Facility Name
Boehringer Ingelheim Investigational Site
City
Aachen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Ahrensburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Altenburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Amberg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Aschaffenburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Auerbach
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Aue
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Augsburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Backnang
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Bad Kissingen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Bad Krozingen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Bad Lippspringe
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Bad Nauheim
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Bad Neustadt
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Bad Soden
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Baunatal
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Beckum
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Bensheim
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
MEDARS GmbH
City
Berlin
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Bernau
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Bielefeld
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Bochum
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Bonn
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Brake
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Brandenburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Braunschweig
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Bruchsal
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Buchholz
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Celle
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Chemnitz
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Cloppenburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Coburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Dachau
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Darmstadt
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Deggendorf
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Delmenhorst
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Detmold
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Dillingen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Dinslaken
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Dortmund
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Dresden
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Duisburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Dülmen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Düren
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Düsseldorf
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Eggenfelden
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Eisenach
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Eisenhüttenstadt
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Emden
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Erfurt
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Erlangen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Essen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Euskirchen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Fellbach
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Fluda
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Frankenthal
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Frankfurt/Main
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Frankfurt/Oder
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Frankfurt
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Freising
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Fulda
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Fürstenfeldbruck
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Fürstenwalde
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Fürth
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Garmisch-Partenkirchen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Gelsenkirchen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Germering
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Goch
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Greiz
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Groß Gaglow
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Großenhain
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Göppingen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Gütersloh
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Hagen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Hamm
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Hartha
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Heidelberg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Heidenheim
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Heilbronn
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Hemmingen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Hildburghausen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Hildesheim
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Homburg/Saar
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Hoyerswerda
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Ingolstadt
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Kamen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Karlsruhe
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Kaufbeuren
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Kempten
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Kiel
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Koblenz
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Krefeld
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Köln
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Köthen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Landshut
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Langenhagen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Leipzig
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Leonberg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Ludwigsburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Lörrach
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Lübeck
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Lüdenscheid
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Lüneburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Magdeburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Mainz
Country
Germany
Facility Name
Johannes-Gutenberg-Universität Mainz
City
Mainz
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Mannheim
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Marburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Markkleeberg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Minden
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Mittweida
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Moers
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Mönchengladbach
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Mühlhausen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
München
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Münster
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Neu-Isenburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Neu-Ulm
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Neubrandenburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Neuss
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Neuwied
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Niesky
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Nordhausen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Nortorf
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Oschatz
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Oschersleben
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Papenburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Potsdam
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Rathenow
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Recklinghausen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Regensburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Rehau
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Remscheid
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Reutlingen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Rhaunen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Rostock
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Rüdersdorf
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Rüsselsheim
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Saarbrücken
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Saarlouis
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Schrobenhausen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Schwabach
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Schweinfurt
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Schwetzingen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Schwäbisch Gmünd
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Siegen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Simmern
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Sindelfingen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Singen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Solingen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Sonneberg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
St. Ingbert
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Stade
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Steinhagen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Stolberg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Stuttgart
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Teuchern
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Ulm
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Uttenreuth
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Vechta
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Velbert
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Verden
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Vöhringen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Waiblingen
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Waren
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Welzheim
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Weyhe
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Wiesbaden
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Wiesloch
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Witten
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Wolfsburg
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Wuppertal
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Zerbst
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Zwickau
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.257_U03-1924.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.257_literature.pdf
Description
Related Info

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Effects of Once Daily Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD) of Different Severity

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