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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00239434 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: tiotropium inhalation powder capsule Drug: ipratropium bromide Metered Dose Inhaler |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | 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). |
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2003 |
| Estimated Study Completion Date: | March 2004 |
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.
Study Hypothesis:
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.
Comparison(s):
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).
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All patients must have a diagnosis of chronic obstructive pulmonary disease according to the following criteria:
Patients must have relatively stable airway obstruction with an FEV1 ? 65% of predicted normal and FEV1 70% of FVC.
Predicted normal values will be based on the following formula. Males: FEV1 pred.(L) = height2(m) x (-0.016 x age(year) + 1.823) Females: FEV1 pred.(L) = height2(m) x (-0.012 x age(year) + 1.4427)
Exclusion Criteria:
Contacts and Locations| China | |
| 1st Hospital of Guangzhou Medical College | |
| Guangzhou, China, 510120 | |
| Peking Union Medical College Hospital | |
| Beijing, China, 100730 | |
| 1st Hospital of Chinese Medical University | |
| Shenyang, China, 110001 | |
| People Hospital of Beijing University | |
| Beijing, China, 100044 | |
| Zhongshan Hospital of Fudan University | |
| Shanghai, China, 200032 | |
| Shanghai 1st People Hospital | |
| Shanghai, China, 200080 | |
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Shanghai |
More Information
| Study ID Numbers: | 205.245 |
| Study First Received: | October 14, 2005 |
| Last Updated: | October 15, 2009 |
| ClinicalTrials.gov Identifier: | NCT00239434 History of Changes |
| Health Authority: | China: State Food and Drug Administration |
|
Parasympatholytics Respiratory System Agents Neurotransmitter Agents Disease Attributes Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Physiological Effects of Drugs Respiration Disorders Anti-Asthmatic Agents Cholinergic Agents Pharmacologic Actions Lung Diseases, Obstructive |
Pathologic Processes Respiratory Tract Diseases Ipratropium Autonomic Agents Therapeutic Uses Lung Diseases Chronic Disease Peripheral Nervous System Agents Tiotropium Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |