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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00292448
First received: February 15, 2006
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 157
Study Start Date: February 2006
Estimated Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292448

Locations
Japan
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, 984-8560
Boehringer Ingelheim Investigational Site
Sendai, Miyagi, Japan, 981-8563
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
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Nippon Boehringer Ingelheim Co., Ltd.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00292448     History of Changes
Other Study ID Numbers: 205.291
Study First Received: February 15, 2006
Last Updated: October 28, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on October 23, 2014