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

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: olodaterol; Drug: Placebo; Drug: tiotropium; Device: Respimat; Drug: tiotropium + olodaterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01559116

2011-004710-42 (EudraCT Number)

1237.20

Details and patient eligibility

About

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.

Enrollment: 219 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

219 participants in 6 patient groups, including a placebo group

tiotropium+olodaterol FDC low dose

Experimental group

Description:

tiotropium+olodaterol FDC low dose; 2 inhalations once daily (a.m. dosing)

Treatment:

Device: Respimat

Drug: tiotropium + olodaterol

Drug: tiotropium + olodaterol

tiotropium+olodaterol FDC high dose

Experimental group

Description:

tiotropium+olodaterol FDC high dose; 2 inhalations once daily (a.m. dosing)

Treatment:

Device: Respimat

Drug: tiotropium + olodaterol

Drug: tiotropium + olodaterol

tiotropium low dose

Active Comparator group

Description:

tiotropium low dose; 2 inhalations once daily (a.m. dosing)

Treatment:

Drug: tiotropium

Drug: tiotropium

Device: Respimat

tiotropium high dose

Active Comparator group

Description:

tiotropium high dose; 2 inhalations once daily (a.m. dosing)

Treatment:

Drug: tiotropium

Drug: tiotropium

Device: Respimat

olodaterol

Active Comparator group

Description:

one dose only; 2 inhalations once daily (a.m. dosing)

Treatment:

Device: Respimat

Drug: olodaterol

placebo

Placebo Comparator group

Description:

2 inhalations once daily (a.m. dosing)

Treatment:

Device: Respimat

Drug: Placebo