- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00292448
A Randomised, Double-blind, Crossover Study of Ba679BR Respimat in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Randomised, Double-blind, Double-dummy, Crossover Efficacy and Safety Comparison of 4-week Treatment Periods of Ba 679 BR Respimat® 5 μg and Tiotropium Inhalation Capsule 18 μg in Patients With COPD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Akita, Akita, Japan, 010-1495
- Boehringer Ingelheim Investigational Site
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Bunkyo-ku, Tokyo, Japan, 113-8431
- Boehringer Ingelheim Investigational Site
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Bunkyo-ku,Tokyo, Japan, 113-0022
- Boehringer Ingelheim Investigational Site
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Habikino, Osaka, Japan, 583-8588
- Boehringer Ingelheim Investigational Site
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Inashiki-gun, Ibaraki, Japan, 300-0395
- Boehringer Ingelheim Investigational Site
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Itami, Hyogo, Japan, 664-8540
- Boehringer Ingelheim Investigational Site
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Kamogawa, Chiba, Japan, 296-0041
- Boehringer Ingelheim Investigational Site
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Kishiwada, Osaka, Japan, 596-8501
- Boehringer Ingelheim Investigational Site
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Komaki, Aichi, Japan, 485-0044
- Boehringer Ingelheim Investigational Site
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Kurume, Fukuoka, Japan, 830-0011
- Boehringer Ingelheim Investigational Site
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Kyoto, Kyoto, Japan, 606-8507
- Boehringer Ingelheim Investigational Site
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Matsumoto, Nagano, Japan, 390-8621
- Boehringer Ingelheim Investigational Site
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Morioka, Iwate, Japan, 020-8505
- Boehringer Ingelheim Investigational Site
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Osaka, Osaka, Japan, 545-8586
- Boehringer Ingelheim Investigational Site
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Osakasayama, Osaka, Japan, 589-0014
- Boehringer Ingelheim Investigational Site
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Sakai, Osaka, Japan, 591-8555
- Boehringer Ingelheim Investigational Site
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Sendai, Miyagi, Japan, 980-8574
- Boehringer Ingelheim Investigational Site
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Sendai, Miyagi, Japan, 981-8563
- Boehringer Ingelheim Investigational Site
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Sendai, Miyagi, Japan, 984-8560
- Boehringer Ingelheim Investigational Site
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Seto, Aichi, Japan, 489-8642
- Boehringer Ingelheim Investigational Site
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Shinjuku-ku, Tokyo, Japan, 160-8582
- Boehringer Ingelheim Investigational Site
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Takatsuki, Osaka, Japan, 569-1096
- Boehringer Ingelheim Investigational Site
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Toyonaka, Osaka, Japan, 560-8552
- Boehringer Ingelheim Investigational Site
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Tsukuba, Ibaraki, Japan, 305-8576
- Boehringer Ingelheim Investigational Site
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Wakayama, Wakayama, Japan, 641-0012
- Boehringer Ingelheim Investigational Site
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Yokohama, Kanagawa, Japan, 236-0051
- Boehringer Ingelheim Investigational Site
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Yokote, Akita, Japan, 013-8610
- Boehringer Ingelheim Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
*: 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:
- Significant diseases except COPD
- Clinically relevant abnormal haematology, blood chemistry, or urinalysis
- Recent history of MI
- Any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past 3 yrs
- Cancer within the last 5 yrs
- Symptomatic prostatic hypertrophy or bladder neck obstruction
- Narrow-angle glaucoma
- History of asthma, allergic rhinitis, atopic disease, or who have a total blood eosinophil count >= 600 mm3
- History of life-threatening pulmonary obstruction, or cystic fibrosis or clinically evident bronchiectasis
- Active tuberculosis
- History of and/or active significant alcohol or drug abuse
- Underwent thoracotomy with pulmonary resection
- Completed a pulmonary rehabilitation program within the 6 weeks prior to the Scr. Visit or who are currently in a pulmonary rehabilitation program
- Regularly use daytime oxygen for more than 1 h/day and in the investigator?s opinion unable to abstain from the use of oxygen
- Took an investigational drug within 1 m or 6 half lives prior to Scr. Visit
- Beta-blockers
- Anti-allergic drugs or antihistamines for asthma, allergic rhinitis, atopic disease, or other allergic disease with a total blood eosinophil count >= 600 mm3
- 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
- Hypersensitivity to anticholinergic drugs, or components of the Respimat delivery system, to lactose or any other component of the inhalation capsule deliver system
- Pregnant or suspect of pregnant or women who are willing to become pregnant during the study period or nursing women
- Who are currently participating in another study
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary outcome is the trough FEV1 response determined at the end of each 4-week period of randomised treatment.
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Secondary Outcome Measures
Outcome Measure |
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Trough FVC response after 4 weeks, peak response (FEV1 and FVC) to first dose, peak response (FEV1 and FVC) after 4 weeks, FEV1 AUC0-3h and FVC AUC0-3h response to first dose and after 4 weeks, individual FEV1and FVC measurements at each time point.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases, Obstructive
- Lung Diseases
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Tiotropium Bromide
Other Study ID Numbers
- 205.291
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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