Tiotropium + Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 1)
| Status: | Completed |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2013 |
| End Date: | November 2014 |
A Randomised, Double-blind, Placebo- and Active-controlled Parallel Group Study to Assess the Efficacy of 12 Weeks of Once Daily Treatment of Two Doses of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (Delivered by the Respimat Inhaler) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The objective of this study is to assess the efficacy and safety of 12 weeks once daily
treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat
inhaler) compared with tiotropium and placebo in patients with COPD.
treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat
inhaler) compared with tiotropium and placebo in patients with COPD.
Inclusion criteria:
- Diagnosis chronic obstructive pulmonary disease
- Relatively stable airway obstruction with post FEV1 >=30 and < 80% predicted normal
and post FEV1/ FVC < 70%
- Male or female patients, 40 years of age or more
- Smoking history more than 10 pack years
Exclusion criteria:
- Significant diseases other than COPD
- History of asthma
- COPD exacerbation in previous 3 months
- Completion of pulmonary rehabilitation program within previous 6 weeks or current
participation in pulmonary rehabilitation program.
- Pregnant or nursing women
- Patients unable to comply with pulmonary medication restrictions
We found this trial at
21
sites
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