Status:
WITHDRAWN
A 12 Week Study of QVA149 Compared to Fluticasone/Salmeterol (Advair) for Treatment of COPD
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in patients with moderate to severe airflow limitation.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01860066
Start Date
December 1 2013
End Date
September 1 2014
Last Update
November 11 2013
Active Locations (31)
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1
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina, 1425
2
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina, C1115AAB
3
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina, C1122AAK
4
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina