Randomised, Double-blind, Placebo-controlled, 6 Treatment, 4 Period, Incomplete Cross-over Trial to Characterise the 24-hour Lung Function Profiles of Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 µg, 5/5 µg), Tiotropium (2.5 µg, 5 µg) and Olodaterol (5 µg) (Oral Inhalation, Delivered by the Respimat® Inhaler) After 6 Weeks Once Daily Treatment in Patients With Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM]
- NCT01559116
- PHASE3
- INTERVENTIONAL
Last updated: 2015-07-16
Purpose of Trial
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.
This study is for people with
Pulmonary Disease, Chronic Obstructive
Interventions being studied
tiotropium + olodaterol
tiotropium
olodaterol
tiotropium
tiotropium + olodaterol
Placebo
Respimat
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
ELIGIBILITY
Gender: ALL
Age: 40+
Healthy Volunteers: No
4 Locations
Jasper
1237.20.1204 Boehringer Ingelheim Investigational Site
Alabama, United States
Easley
1237.20.1203 Boehringer Ingelheim Investigational Site
South Carolina, United States
Greenville
1237.20.1201 Boehringer Ingelheim Investigational Site
South Carolina, United States
Spartanburg
1237.20.1202 Boehringer Ingelheim Investigational Site
South Carolina, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov