Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the trial is to compare the lung function profile of once daily treatment with tiotropium+olodaterol FDC [2.5/ 5µg and 5/ 5µg] delivered by the RESPIMAT with the lung function profile of twice daily treatment with fluticasone propionate+salmeterol FDC [250/50µg and 500/50µg] delivered by the Accuhaler® after 6 weeks of treatment.

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

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Fluticasone; Olodaterol; Salmeterol Xinafoate; Tiotropium Bromide; Xhance

Criteria

Inclusion criteria:

1. Diagnosis of chronic obstructive pulmonary disease

2. Relatively stable airway obstruction with a post-bronchodilator 30%Expiratory Volume in 1 second (FEV1)<80% of predicted normal and a post-bronchodilator FEV1/(Forced Vital Capacity)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, Accuhaler and from a metered dose inhaler (MDI)

Exclusion criteria:

1. Significant disease other than COPD

2. COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or iv) or hospitalization in the last 3 months.

3. Clinically relevant abnormal lab values

4. History of asthma

5. Diagnosis of thyrotoxicosis

6. Diagnosis of paroxysmal tachycardia

7. History of myocardial infarction

8. Unstable or life-threatening cardiac arrhythmia

9. Hospitalization for heart failure within the past year

10. Known active tuberculosis

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

12. History of life-threatening pulmonary obstruction

13. History of cystic fibrosis

14. Clinically evident bronchiectasis

15. History of significant alcohol or drug abuse

16. History of thoracotomy with pulmonary resection

17. oral or patch ß-adrenergics

18. Oral corticosteroid medication within 6 weeks prior to Visit 1

19. Regular use daytime oxygen therapy for more than one hour per day

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

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

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

23. Pregnant or nursing women