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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00292448 |
The objective of this trial is to compare the efficacy and the safety of Ba 679 BR Respimat 5 ug once daily to tiotropium inhalation capsule 18 ug (Spiriva inhalation capsule) in a crossover study of 4-week treatment periods in patients with COPD.
Condition | Intervention | Phase |
---|---|---|
Pulmonary Disease, Chronic Obstructive |
Drug: Ba 679 BR Respimat Drug: Tiotropium (Spiriva) inhalation capsule 18 ug |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Tiotropium Respimat Ph2 Crossover Study in COPD (Japan) |
Estimated Enrollment: | 130 |
Estimated Study Completion Date: | March 2007 |
This is a 16-week, multi-centre, randomised, double-blind, double-dummy, crossover study of 4-week randomised treatment periods to demonstrate the efficacy and safety of 5 ug of Ba 679 BR inhalation solution from Respimat compared to tiotropium inhalation powder capsule (18 ug) via HandiHaler in patients with COPD. The two 4-week randomised treatment periods are separated by 4-week washout period.
Study Hypothesis:
The primary aim of this trial is to demonstrate non-inferiority of lung function response to 5 ug (2 actuations of 2.5 ug) of Ba679BR Respimat delivered by the Respimat inhaler once daily compared to tiotropium (18 ug) inhaled as powder capsule from the HandiHaler once daily at the end of 4-week treatment periods in patients with COPD. The hypothesis test of non-inferiority will be performed at alpha = 0.025 (one-sided).
Comparison(s):
The primary efficacy endpoint is the trough FEV1 response determined at the end of each 4-week period of randomised treatment.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
participation in the trial 2. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 =< 70% of predicted normal* and FEV1 =< 70% of FVC (Visits 1 and 2).
Males: FEV1 predicted (L) = 0.036 x (height (cm)) ? 0.028 x age (years) ? 1.178 Females: FEV1 predicted (L) = 0.022 x (height (cm)) ? 0.022 x age (years) ? 0.005
Pack Years = [Number of cigarettes/ day / 20] x years of smoking 5. Patients must be able to perform technically acceptable pulmonary function tests.
6. Patients must be able to inhale medication in a competent manner from the Respimat inhaler and the HandiHaler.
Patients with/who:
Japan | |
Boehringer Ingelheim Investigational Site | |
Morioka, Iwate, Japan, 020-8505 | |
Boehringer Ingelheim Investigational Site | |
Sendai, Miyagi, Japan, 980-8574 | |
Boehringer Ingelheim Investigational Site | |
Sendai, Miyagi, Japan, 981-8563 | |
Boehringer Ingelheim Investigational Site | |
Akita, Akita, Japan, 010-1495 | |
Boehringer Ingelheim Investigational Site | |
Yokote, Akita, Japan, 013-8610 | |
Boehringer Ingelheim Investigational Site | |
Inashiki-gun, Ibaraki, Japan, 300-0395 | |
Boehringer Ingelheim Investigational Site | |
Tsukuba, Ibaraki, Japan, 305-8576 | |
Boehringer Ingelheim Investigational Site | |
Kamogawa, Chiba, Japan, 296-0041 | |
Boehringer Ingelheim Investigational Site | |
Shinjuku-ku, Tokyo, Japan, 160-8582 | |
Boehringer Ingelheim Investigational Site | |
Bunkyo-ku, Tokyo, Japan, 113-8431 | |
Boehringer Ingelheim Investigational Site | |
Yokohama, Kanagawa, Japan, 236-0051 | |
Boehringer Ingelheim Investigational Site | |
Matsumoto, Nagano, Japan, 390-8621 | |
Boehringer Ingelheim Investigational Site | |
Seto, Aichi, Japan, 489-8642 | |
Boehringer Ingelheim Investigational Site | |
Sendai, Miyagi, Japan, 984-8560 | |
Boehringer Ingelheim Investigational Site | |
Kyoto, Kyoto, Japan, 606-8507 | |
Boehringer Ingelheim Investigational Site | |
Osaka, Osaka, Japan, 545-8586 | |
Boehringer Ingelheim Investigational Site | |
Sakai, Osaka, Japan, 591-8555 | |
Boehringer Ingelheim Investigational Site | |
Toyonaka, Osaka, Japan, 560-8552 | |
Boehringer Ingelheim Investigational Site | |
Takatsuki, Osaka, Japan, 569-1096 | |
Boehringer Ingelheim Investigational Site | |
Habikino, Osaka, Japan, 583-8588 | |
Boehringer Ingelheim Investigational Site | |
Osakasayama, Osaka, Japan, 589-0014 | |
Boehringer Ingelheim Investigational Site | |
Kishiwada, Osaka, Japan, 596-8501 | |
Boehringer Ingelheim Investigational Site | |
Itami, Hyogo, Japan, 664-8540 | |
Boehringer Ingelheim Investigational Site | |
Wakayama, Wakayama, Japan, 641-0012 | |
Boehringer Ingelheim Investigational Site | |
Kurume, Fukuoka, Japan, 830-0011 | |
Boehringer Ingelheim Investigational Site | |
Bunkyo-ku,Tokyo, Japan, 113-0022 | |
Boehringer Ingelheim Investigational Site | |
Komaki, Aichi, Japan, 485-0044 |
Study Chair: | Boehringer Ingelheim Study Coordinator | Nippon Boehringer Ingelheim Co., Ltd. |
Study ID Numbers: | 205.291 |
Study First Received: | February 15, 2006 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00292448 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Neurotransmitter Agents Cholinergic Antagonists Respiration Disorders Anti-Asthmatic Agents Cholinergic Agents Lung Diseases, Obstructive Respiratory Tract Diseases |
Lung Diseases Chronic Disease Peripheral Nervous System Agents Tiotropium Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |
Respiratory System Agents Parasympatholytics Neurotransmitter Agents Disease Attributes Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Respiration Disorders Physiological Effects of Drugs Anti-Asthmatic Agents Cholinergic Agents Pharmacologic Actions |
Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Chronic Disease Peripheral Nervous System Agents Tiotropium Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |