A Randomised, Double-blind, Crossover Study of Ba679BR Respimat in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00292448
Recruitment Status : Completed
First Posted : February 16, 2006
Last Update Posted : October 29, 2013
Information provided by:
Boehringer Ingelheim

Brief Summary:
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 or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Ba 679 BR Respimat Drug: Tiotropium (Spiriva) inhalation capsule 18 ug Phase 2

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).


The primary efficacy endpoint is the trough FEV1 response determined at the end of each 4-week period of randomised treatment.

Study Type : Interventional  (Clinical Trial)
Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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 Start Date : February 2006
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD
U.S. FDA Resources

Primary Outcome Measures :
  1. The primary outcome is the trough FEV1 response determined at the end of each 4-week period of randomised treatment.

Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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).

*: 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00292448

Boehringer Ingelheim Investigational Site
Akita, Akita, Japan, 010-1495
Boehringer Ingelheim Investigational Site
Bunkyo-ku, Tokyo, Japan, 113-8431
Boehringer Ingelheim Investigational Site
Bunkyo-ku,Tokyo, Japan, 113-0022
Boehringer Ingelheim Investigational Site
Habikino, Osaka, Japan, 583-8588
Boehringer Ingelheim Investigational Site
Inashiki-gun, Ibaraki, Japan, 300-0395
Boehringer Ingelheim Investigational Site
Itami, Hyogo, Japan, 664-8540
Boehringer Ingelheim Investigational Site
Kamogawa, Chiba, Japan, 296-0041
Boehringer Ingelheim Investigational Site
Kishiwada, Osaka, Japan, 596-8501
Boehringer Ingelheim Investigational Site
Komaki, Aichi, Japan, 485-0044
Boehringer Ingelheim Investigational Site
Kurume, Fukuoka, Japan, 830-0011
Boehringer Ingelheim Investigational Site
Kyoto, Kyoto, Japan, 606-8507
Boehringer Ingelheim Investigational Site
Matsumoto, Nagano, Japan, 390-8621
Boehringer Ingelheim Investigational Site
Morioka, Iwate, Japan, 020-8505
Boehringer Ingelheim Investigational Site
Osaka, Osaka, Japan, 545-8586
Boehringer Ingelheim Investigational Site
Osakasayama, Osaka, Japan, 589-0014
Boehringer Ingelheim Investigational Site
Sakai, Osaka, Japan, 591-8555
Boehringer Ingelheim Investigational Site
Sendai, Miyagi, Japan, 980-8574
Boehringer Ingelheim Investigational Site
Sendai, Miyagi, Japan, 981-8563
Boehringer Ingelheim Investigational Site
Sendai, Miyagi, Japan, 984-8560
Boehringer Ingelheim Investigational Site
Seto, Aichi, Japan, 489-8642
Boehringer Ingelheim Investigational Site
Shinjuku-ku, Tokyo, Japan, 160-8582
Boehringer Ingelheim Investigational Site
Takatsuki, Osaka, Japan, 569-1096
Boehringer Ingelheim Investigational Site
Toyonaka, Osaka, Japan, 560-8552
Boehringer Ingelheim Investigational Site
Tsukuba, Ibaraki, Japan, 305-8576
Boehringer Ingelheim Investigational Site
Wakayama, Wakayama, Japan, 641-0012
Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa, Japan, 236-0051
Boehringer Ingelheim Investigational Site
Yokote, Akita, Japan, 013-8610
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Study Coordinator Nippon Boehringer Ingelheim Co., Ltd. Identifier: NCT00292448     History of Changes
Other Study ID Numbers: 205.291
First Posted: February 16, 2006    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action