A Comparison of 18g of Tiotropium Inhalation Capsules Once Daily and Atrovent Metered Dose Inhaler (2 Puffs of 20g, 4 Times Daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)
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|ClinicalTrials.gov Identifier: NCT00239434|
Recruitment Status : Completed
First Posted : October 17, 2005
Last Update Posted : May 14, 2012
|First Submitted Date ICMJE||October 14, 2005|
|First Posted Date ICMJE||October 17, 2005|
|Last Update Posted Date||May 14, 2012|
|Study Start Date ICMJE||June 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Trough FEV1 response: change from baseline trough FEV1 (visit 2) at visit 4|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00239434 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Trough FEV1 response at visit 3 Average FEV1 (AUC0-3) response (change from baseline) for the 3 hours post drug administration Trough FVC response Average FVC (AUC0-3) response (as defined for FEV1) 5. Amount of rescue medication 6. Patient questionnaire|
|Original Secondary Outcome Measures ICMJE
||1. Trough FEV1 response at visit 3 2. Average FEV1 (AUC0-3) response (change from baseline) for the 3 hours post drug administration 3. Trough FVC response 4. Average FVC (AUC0-3) response (as defined for FEV1) 5. Amount of rescue medication 6. Patient q|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||A Comparison of 18g of Tiotropium Inhalation Capsules Once Daily and Atrovent Metered Dose Inhaler (2 Puffs of 20g, 4 Times Daily) in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)|
|Official Title ICMJE||Comparison of 18 mg of Tiotropium Inhalation Capsules Once Daily and Atrovent Metered Dose Inhaler (2 Puffs of 20 mg, Four Times Daily) in a Double-Blind, Double-dummy, Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease (COPD).|
|Brief Summary||The objective of this study is to compare the bronchodilator efficacy and safety of once daily dosing of tiotropium inhalation capsules (18 ?g) and Atrovent? MDI (2 puffs of ipratropium bromide 20 ?g four times daily) in patients with chronic obstructive pulmonary disease.|
This is a randomized, double-blind, double-dummy, parallel group study to compare the bronchodilator efficacy and safety of tiotropium inhalation capsules and Atrovent? MDI in patients with chronic obstructive pulmonary disease (COPD).
Following an initial screening visit, patients will enter a 2-week baseline period. Patients who successfully complete this phase will be randomized into the double-blind portion of the study in which they will receive tiotropium once daily (morning) or Atrovent? four times daily for 4 weeks. Pulmonary function testing will be conducted just prior (i.e. 5 minutes before) to the start of therapy at Visit 2 (i.e. randomization visit after completion of the 2-week run-in period) and at 30, 60, 120 and 180 minutes post-dosing. Pulmonary function testing will be repeated at the same time intervals after 14 days of therapy (visit 3) and at the end of therapy.
Those patients taking theophylline, will be questioned about their last theophylline intake in order to ensure adherence to the washout requirements.
Vital signs will be measured in conjunction with the pulmonary function tests. Adverse events will be recorded throughout the entire run-in and treatment period.
The null hypothesis is that there is no difference in mean response between tiotropium and Atrovent. The alternative hypothesis is that there is a difference in mean response between tiotropium and Atrovent.
The primary pulmonary function variable will be FEV1 (Forced Expiratory Volume in one second) and trough FEV1 response at the end of the four week treatment period, i.e. visit 4, will be the primary efficacy endpoint.
Trough FEV1 is defined as FEV1 at the end of the dosing interval (for tiotropium at approximately 24 hours post treatment administration). On test days (Visits 3 and 4) it is measured by the PFT just prior to dosing. Trough FEV1 response is defined as change from baseline in trough FEV1. Baseline FEV1 is defined as FEV1 measured just prior to first dosing in the morning of randomization visit (Visit 2).
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Condition ICMJE||Pulmonary Disease, Chronic Obstructive|
|Study Arms ICMJE||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date ICMJE||March 2004|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages ICMJE||40 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||China|
|Removed Location Countries|
|NCT Number ICMJE||NCT00239434|
|Other Study ID Numbers ICMJE||205.245|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Boehringer Ingelheim|
|Collaborators ICMJE||Not Provided|
|PRS Account||Boehringer Ingelheim|
|Verification Date||May 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP