A Randomised, Double-blind, Crossover Study of Ba679BR Respimat in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT00292448
Last Updated: 2013-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
157 participants
INTERVENTIONAL
2006-02-28
2007-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ba 679 BR Respimat
Tiotropium (Spiriva) inhalation capsule 18 ug
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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).
\*: Predicted normal values will be calculated according to the formulas for Japanese predicted normal values (R05-0607) (see below).
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
? Patients must maintain stable COPD medications for 1 month prior to Visit 1. 3. Male or female patients 40 years of age or older. 4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years.
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:
1. Significant diseases except COPD
2. Clinically relevant abnormal haematology, blood chemistry, or urinalysis
3. Recent history of MI
4. Any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past 3 yrs
5. Cancer within the last 5 yrs
6. Symptomatic prostatic hypertrophy or bladder neck obstruction
7. Narrow-angle glaucoma
8. History of asthma, allergic rhinitis, atopic disease, or who have a total blood eosinophil count \>= 600 mm3
9. History of life-threatening pulmonary obstruction, or cystic fibrosis or clinically evident bronchiectasis
10. Active tuberculosis
11. History of and/or active significant alcohol or drug abuse
12. Underwent thoracotomy with pulmonary resection
13. Completed a pulmonary rehabilitation program within the 6 weeks prior to the Scr. Visit or who are currently in a pulmonary rehabilitation program
14. Regularly use daytime oxygen for more than 1 h/day and in the investigator?s opinion unable to abstain from the use of oxygen
15. Took an investigational drug within 1 m or 6 half lives prior to Scr. Visit
16. Beta-blockers
17. Anti-allergic drugs or antihistamines for asthma, allergic rhinitis, atopic disease, or other allergic disease with a total blood eosinophil count \>= 600 mm3
18. Oral corticosteroids at unstable doses or at doses in excess of the equivalent of 10 mg of prednisone/day or 20 mg every other day
19. Hypersensitivity to anticholinergic drugs, or components of the Respimat delivery system, to lactose or any other component of the inhalation capsule deliver system
20. Pregnant or suspect of pregnant or women who are willing to become pregnant during the study period or nursing women
21. Who are currently participating in another study
22. The randomisation of patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the Scr. Visit or during the scr. period should be postponed
40 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
Nippon Boehringer Ingelheim Co., Ltd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Boehringer Ingelheim Investigational Site
Akita, Akita, , Japan
Boehringer Ingelheim Investigational Site
Bunkyo-ku, Tokyo, , Japan
Boehringer Ingelheim Investigational Site
Bunkyo-ku,Tokyo, , Japan
Boehringer Ingelheim Investigational Site
Habikino, Osaka, , Japan
Boehringer Ingelheim Investigational Site
Inashiki-gun, Ibaraki, , Japan
Boehringer Ingelheim Investigational Site
Itami, Hyogo, , Japan
Boehringer Ingelheim Investigational Site
Kamogawa, Chiba, , Japan
Boehringer Ingelheim Investigational Site
Kishiwada, Osaka, , Japan
Boehringer Ingelheim Investigational Site
Komaki, Aichi, , Japan
Boehringer Ingelheim Investigational Site
Kurume, Fukuoka, , Japan
Boehringer Ingelheim Investigational Site
Kyoto, Kyoto, , Japan
Boehringer Ingelheim Investigational Site
Matsumoto, Nagano, , Japan
Boehringer Ingelheim Investigational Site
Morioka, Iwate, , Japan
Boehringer Ingelheim Investigational Site
Osaka, Osaka, , Japan
Boehringer Ingelheim Investigational Site
Osakasayama, Osaka, , Japan
Boehringer Ingelheim Investigational Site
Sakai, Osaka, , Japan
Boehringer Ingelheim Investigational Site
Sendai, Miyagi, , Japan
Boehringer Ingelheim Investigational Site
Sendai, Miyagi, , Japan
Boehringer Ingelheim Investigational Site
Sendai, Miyagi, , Japan
Boehringer Ingelheim Investigational Site
Seto, Aichi, , Japan
Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, , Japan
Boehringer Ingelheim Investigational Site
Takatsuki, Osaka, , Japan
Boehringer Ingelheim Investigational Site
Toyonaka, Osaka, , Japan
Boehringer Ingelheim Investigational Site
Tsukuba, Ibaraki, , Japan
Boehringer Ingelheim Investigational Site
Wakayama, Wakayama, , Japan
Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, , Japan
Boehringer Ingelheim Investigational Site
Yokote, Akita, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
205.291
Identifier Type: -
Identifier Source: org_study_id