A 12 Week Study of QVA149 Compared to Fluticasone/Salmeterol (Advair) for Treatment of COPD
Status: | Completed |
---|---|
Conditions: | Chronic Obstructive Pulmonary Disease, Pulmonary |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 10/3/2013 |
Start Date: | July 2013 |
End Date: | March 2014 |
Contact: | Novartis Pharmaceuticals |
Phone: | 1-888-669-6682 |
A 12-week Treatment, Multi-center, Randomized, Double-blind, Double-dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in COPD Patients With Moderate to Severe Airflow Limitation
Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in
patients with moderate to severe airflow limitation
Inclusion Criteria:
- Age >= 40 years, patients with airflow limitation indicated by post-bronchdilation
FEV1 >=30% and <80% of predicted normal, current or ex-smokers with a 10 pack year
smoking history, patients with a mMRC grade 2 or greater
Exclusion Criteria:
- prolonged QTCF >450 ms, paroxysmal atrial fibrillation, Type I or uncontrolled Type
II diabetes, history of asthma, COPD diagnosis before age 40, receiving treatments
not allowed in the study, other concomitant pulmonary diseases.
Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
20
sites
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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