Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Olodaterol; Tiotropium Bromide

Criteria

Inclusion criteria:

1. Diagnosis of chronic obstructive pulmonary disease

2. Relatively stable airway obstruction with a post-bronchodilator FEV1< 80% of predicted normal and a post-bronchodilator FEV1/FVC <70%

3. Male or female patients, 40 years of age or older

4. Smoking history of more than 10 pack years

5. Ability to perform technically acceptable pulmonary function tests and maintain records

6. Ability to inhale medication in a competent manner from the RESPIMAT Inhaler and from a metered dose inhaler (MDI)

Exclusion criteria:

1. significant disease other than COPD

2. clinically relevant abnormal lab values

3. history of asthma

4. diagnosis of thyrotoxicosis

5. diagnosis of paroxysmal tachycardia

6. history of myocardial infarction

7. unstable or life-threatening cardiac arrhythmia

8. Hospitalization for heart failure within the past year

9. known active tuberculosis

10. malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years

11. history of life-threatening pulmonary obstruction

12. history of cystic fibrosis

13. clinically evident bronchiectasis

14. history of significant alcohol or drug abuse

15. history of thoracotomy with pulmonary resection

16. oral or patch ß-adrenergics

17. oral corticosteroid medication at unstable doses

18. regular use daytime oxygen therapy for more than one hour per day

19. Pulmonary rehabilitation program in the six weeks prior to the screening visit

20. Investigational drug within one month or six half lives (whichever is greater) prior to screening visit

21. Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA

22. Pregnant or nursing women

23. Women of childbearing potential not using a highly effective method of birth control

24. Patients who have previously been randomised in this study or are currently participating in another study

25. Patients who are unable to comply with pulmonary medication restrictions prior to randomisation