A 12 Week Study of QVA149 Compared to Fluticasone/Salmeterol (Advair) for Treatment of COPD
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: QVA149 (Drug); fluticasone/salmeterol (Drug)
Phase: Phase 3
Status: Withdrawn
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals
Summary
Study is to show that QVA149 is superior to the standard of care, fluticasone/salmeterol, in
patients with moderate to severe airflow limitation
Clinical Details
Official title: 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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Area under the curve (AUC) 0-12 hours for FEV1 following 12 weeks of treatment
Secondary outcome: Trough Forced Expiratory Volume in 1 second (FEV1) following 12 weeks of treatmentTransition Dyspnea Index (TDI) Focal Score Quality of Lfe Assessment with St George's Respiratory Questionaire (SGRQ) Change from baseline in daily number of puffs of rescue medication Daily symptoms reported by patient COPD assessment (CAT) test Safety and tolerability Peak Forced Expiratory Volume in 1 second (FEV1) within 4 hours post-dose Area under the curve (AUC) 0-4 hours for FEV1
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Novartis Investigative Site, Feldkirch 6800, Austria
Novartis Investigative Site, Grieskirchen 4710, Austria
Novartis Investigative Site, Hallein 5400, Austria
Novartis Investigative Site, Linz 4020, Austria
Novartis Investigative Site, Thalheim bei Wels 4600, Austria
Novartis Investigative Site, Wels 4600, Austria
Novartis Investigative Site, Aschaffenburg 63739, Germany
Novartis Investigative Site, Bad Woerishofen 86825, Germany
Novartis Investigative Site, Berlin 10119, Germany
Novartis Investigative Site, Berlin 13156, Germany
Novartis Investigative Site, Berlin 10717, Germany
Novartis Investigative Site, Berlin 10789, Germany
Novartis Investigative Site, Berlin 12203, Germany
Novartis Investigative Site, Berlin 12687, Germany
Novartis Investigative Site, Berlin 10117, Germany
Novartis Investigative Site, Dresden 01307, Germany
Novartis Investigative Site, Frankfurt 60389, Germany
Novartis Investigative Site, Frankfurt 60596, Germany
Novartis Investigative Site, Grosshansdorf 22947, Germany
Novartis Investigative Site, Hamburg 20253, Germany
Novartis Investigative Site, Hamburg 20354, Germany
Novartis Investigative Site, Hamburg 22335, Germany
Novartis Investigative Site, Hannover 30317, Germany
Novartis Investigative Site, Leipzig 04207, Germany
Novartis Investigative Site, Leipzig 04357, Germany
Novartis Investigative Site, Lübeck 23552, Germany
Novartis Investigative Site, Münster 48145, Germany
Novartis Investigative Site, Potsdam 14467, Germany
Novartis Investigative Site, Rheine 48431, Germany
Additional Information
Starting date: December 2013
Last updated: November 8, 2013
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