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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Tiotropium Bromide

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