DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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Status: Withdrawn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 treatment

Transition 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017