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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Status: Withdrawn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

Peak Forced Expiratory Volume in 1 second (FEV1) within 4 hours post-dose

Area under the curve (AUC) 0-4 hours for FEV1

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

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, Buenos Aires 1425, Argentina

Novartis Investigative Site, Buenos Aires C1115AAB, Argentina

Novartis Investigative Site, Buenos Aires C1122AAK, Argentina

Novartis Investigative Site, Buenos Aires, Argentina

Novartis Investigative Site, Mendoza 5500, Argentina

Novartis Investigative Site, Mendoza M5500CBA, Argentina

Novartis Investigative Site, Antwerpen 2060, Belgium

Novartis Investigative Site, Bruxelles 1000, Belgium

Novartis Investigative Site, Genk 3600, Belgium

Novartis Investigative Site, Gilly 6060, Belgium

Novartis Investigative Site, Hasselt 3500, Belgium

Novartis Investigative Site, Jambes 5100, Belgium

Novartis Investigative Site, Barranquilla, Colombia

Novartis Investigative Site, Florida Blanca, Colombia

Novartis Investigative Site, MedellĂ­n, Colombia

Novartis Investigative Site, Cvikov 471 54, Czech Republic

Novartis Investigative Site, Jindrichuv Hradec 377 01, Czech Republic

Novartis Investigative Site, Karlovy Vary 360 66, Czech Republic

Novartis Investigative Site, Kurim 664 34, Czech Republic

Novartis Investigative Site, Pardubice 530 09, Czech Republic

Novartis Investigative Site, Teplice 415 01, Czech Republic

Novartis Investigative Site, Karamsad 388225, India

Novartis Investigative Site, Guntur, Andhra Pradesh 522 001, India

Novartis Investigative Site, Kyjov, CZE 697 70, Czech Republic

Novartis Investigative Site, Ahmedabad, Gujarat 380 008, India

Novartis Investigative Site, Faridabad, Haryana 121 001, India

Novartis Investigative Site, Bangalore, Karnataka 560 002, India

Novartis Investigative Site, Nagpur, Maharashtra 400 012, India

Novartis Investigative Site, Pune, Maharashtra 411004, India

Novartis Investigative Site, Jaipur, Rajasthan 302004, India

Novartis Investigative Site, San Miguel de Tucuman, Tucuman 4000, Argentina

Additional Information

Starting date: December 2013
Last updated: November 8, 2013

Page last updated: August 23, 2015

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