Back to resultsEfficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tiotropium
Respimat SMI
HandiHaler
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion Criteria: Diagnosis of COPD FEV1 < 60% predicted FEV1 < 70% of FVC Smoking history of 10 pack-years Exclusion Criteria: Significant other disease than COPD Recent history of MI (1 year or less) Cardiac arrhythmia requiring drug therapy History of asthma, allergic rhinitis or eosinophil count > 600 mm3 Symptomatic prostatic hypertrophy or bladder neck obstruction Known narrow-angle glaucoma Abnormal baseline hematology, blood chemistry or urinalysis History of cancer within last 5 years Life-threatening pulmonary obstruction Cystic fibrosis or bronchiectasis Tuberculosis Pulmonary resection
Sites / Locations
- Boehringer Ingelheim Investigational Site
- Boehringer Ingelheim Investigational Site
Outcomes
Primary Outcome Measures
Comparison of trough FEV1 values at the end of 4-week treatment with tiotropium inhalation solution (5 mcg, 10 mcg) to that achieved with tiotropium inhalation powder (Spiriva 18 mcg).
Secondary Outcome Measures
Trough forced vital capacity (FVC) response after 4 weeks (change from baseline)
Peak response (FEV1 and FVC) to first dose
Peak response (FEV1 and FVC) after 4 weeks
FEV1 AUC0-12h and FVC AUC0-12h response after 4 weeks
FEV1 AUC0-3h and FVC AUC0-3h response after the first dose and after 4 weeks
Individual FEV1and FVC measurements at each time point
Pre-dose morning and evening peak expiratory flow rate (PEFR) measured by patients
Number of occasions of rescue therapy used as required (p.r.n. salbutamol)
Median time to onset of therapeutic response after first dose
Number of patients with 15% response above baseline for each treatment at each timepoint after first dose
Number of patients with 15% response above baseline for each treatment at each timepoint after 4 weeks
Full Information
NCT ID
NCT00281567
First Posted
January 24, 2006
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT00281567
Brief Title
Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A Randomised, Double-blind, Double-dummy, Placebo-controlled, Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Tiotropium Inhalation Powder Capsule (18μg) Delivered by the HandiHaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
Comparison of lung function response between tiotropium inhalation solution and Spiriva HandiHaler.
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
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Intervention Type
Device
Intervention Name(s)
Respimat SMI
Intervention Type
Device
Intervention Name(s)
HandiHaler
Primary Outcome Measure Information:
Title
Comparison of trough FEV1 values at the end of 4-week treatment with tiotropium inhalation solution (5 mcg, 10 mcg) to that achieved with tiotropium inhalation powder (Spiriva 18 mcg).
Secondary Outcome Measure Information:
Title
Trough forced vital capacity (FVC) response after 4 weeks (change from baseline)
Time Frame
baseline until week 28
Title
Peak response (FEV1 and FVC) to first dose
Time Frame
within 3 hours to first dose
Title
Peak response (FEV1 and FVC) after 4 weeks
Time Frame
within 3 hours after 4 weeks
Title
FEV1 AUC0-12h and FVC AUC0-12h response after 4 weeks
Time Frame
after 4 weeks
Title
FEV1 AUC0-3h and FVC AUC0-3h response after the first dose and after 4 weeks
Time Frame
after first dose and after 4 weeks
Title
Individual FEV1and FVC measurements at each time point
Time Frame
up to 28 weeks
Title
Pre-dose morning and evening peak expiratory flow rate (PEFR) measured by patients
Time Frame
up to 28 weeks
Title
Number of occasions of rescue therapy used as required (p.r.n. salbutamol)
Time Frame
up to 28 weeks
Title
Median time to onset of therapeutic response after first dose
Time Frame
after 4 weeks
Title
Number of patients with 15% response above baseline for each treatment at each timepoint after first dose
Time Frame
at week 4, 12, 20
Title
Number of patients with 15% response above baseline for each treatment at each timepoint after 4 weeks
Time Frame
at week 8, 16, 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of COPD
FEV1 < 60% predicted
FEV1 < 70% of FVC
Smoking history of 10 pack-years
Exclusion Criteria:
Significant other disease than COPD
Recent history of MI (1 year or less)
Cardiac arrhythmia requiring drug therapy
History of asthma, allergic rhinitis or eosinophil count > 600 mm3
Symptomatic prostatic hypertrophy or bladder neck obstruction
Known narrow-angle glaucoma
Abnormal baseline hematology, blood chemistry or urinalysis
History of cancer within last 5 years
Life-threatening pulmonary obstruction
Cystic fibrosis or bronchiectasis
Tuberculosis
Pulmonary resection
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
Study chairs or principal investigators
Country
Belgium
Facility Name
Boehringer Ingelheim Investigational Site
City
Study chairs or principal investigators
Country
Netherlands
12. IPD Sharing Statement
Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.250.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.250_literature.pdf
Description
Related Info
Learn more about this trial
Efficacy and Safety Comparison of Tiotropium Inhalation Solution (Respimat Inhaler) and Spiriva HandiHaler in Chronic Obstructive Pulmonary Disease (COPD)
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