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The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (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); Tiotropium (Drug); Placebo to QVA149 (Drug); Placebo to tiotropium (Drug); Salbutamol/albuterol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

This study assessed the effect of QVA149 on patient-reported dyspnea in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.

Clinical Details

Official title: A Multicenter, Randomized, Blinded, Double-dummy, Placebo-controlled, 3-period Cross-over Study to Evaluate the Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), Using Tiotropium as an Active Control

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo

Secondary outcome:

Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Tiotropium

Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 5min-4h After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium

Standardized Forced Vital Capacity (FVC) Area Under the Curve (AUC) 5min-4 Hrs After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium

Change From Baseline in The Capacity of Daily Living During the Morning (CDLM) Score Averaged Over 6 Weeks of Treatment

Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Used Over the 6 Weeks of Treatment

Detailed description: This study used a multi-center, randomized, blinded, double-dummy placebo controlled, three-period crossover design to assess the effect of once daily QVA149 q. d vs. placebo and tiotropium 18 μg q. d. in terms of patient reported dyspnea as assessed by Baseline Dyspnea Index (BDI)/Transient Dyspnea Index (TDI)(SAC version) in patients with moderate to severe COPD.

Eligibility

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with moderate to severe stable chronic obstructive pulmonary disease

- Smoking history of 10 pack years

- Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) between 30 - 80%

- Patients must be able to use computer mouse and display

- mMRC grade>2

Exclusion Criteria:

- Patients with a history of long QT syndrome

- Patients with Type I or uncontrolled Type II diabetes

- Patients who have had a COPD exacerbation or respiratory tract infection within 6

weeks prior to screening

- Patients with any history of asthma

- Patients with pulmonary lobectomy, lung volume reduction surgery, or lung

transplantation

- Patients with concomitant pulmonary disease

- Patients requiring long term oxygen therapy (>15 h a day)

Other protocol-defined inclusion/exclusion criteria may apply.

Locations and Contacts

Novartis Investigative Site, Bruxelles 1000, Belgium

Novartis Investigative Site, Gilly 6060, Belgium

Novartis Investigative Site, Jambes 5100, Belgium

Novartis Investigative Site, Jette 1090, Belgium

Novartis Investigative Site, Leuven 3000, Belgium

Novartis Investigative Site, Liege 4000, Belgium

Novartis Investigative Site, Oostende 8400, Belgium

Novartis Investigative Site, Wavre 1301, Belgium

Novartis Investigative Site, Aschaffenburg 63739, Germany

Novartis Investigative Site, Berlin 10789, Germany

Novartis Investigative Site, Berlin 12099, Germany

Novartis Investigative Site, Berlin 12203, Germany

Novartis Investigative Site, Berlin 13156, Germany

Novartis Investigative Site, Frankfurt 60389, Germany

Novartis Investigative Site, Halle 06108, Germany

Novartis Investigative Site, Hannover 30317, Germany

Novartis Investigative Site, Leipzig 04275, Germany

Novartis Investigative Site, Leipzig 04207, Germany

Novartis Investigative Site, Leipzig 04103, Germany

Novartis Investigative Site, Leipzig 04357, Germany

Novartis Investigative Site, Mainz D-55101, Germany

Novartis Investigative Site, Potsdam 14467, Germany

Novartis Investigative Site, Potsdam 14478, Germany

Novartis Investigative Site, Rheine 48431, Germany

Novartis Investigative Site, Rüdersdorf 15562, Germany

Novartis Investigative Site, Madrid 28007, Spain

Novartis Investigative Site, Bradford BD9 6RJ, United Kingdom

Novartis Investigative Site, Glasgow G11 6NT, United Kingdom

Novartis Investigative Site, Newcastle-upon-Tyne NE7 7DN, United Kingdom

Novartis Investigative Site, Portsmouth PO6 3AD, United Kingdom

Novartis Investigative Site, Malaga, Andalucia 29010, Spain

Novartis Investigative Site, Mérida, Badajoz 06800, Spain

Novartis Investigative Site, Badalona, Barcelona 08914, Spain

Novartis Investigative Site, Ponferrada, Leon 24400, Spain

Novartis Investigative Site, Salford, Manchester M6 8HD, United Kingdom

Novartis Investigative Site, Burlington, Ontario L7N 3V2, Canada

Novartis Investigative Site, Mississauga, Ontario L5M 2V8, Canada

Novartis Investigative Site, Toronto, Ontario M5G1N8, Canada

Novartis Investigative Site, Toronto, Ontario M6H 3M2, Canada

Novartis Investigative Site, Laval, Quebec H7S 2M5, Canada

Novartis Investigative Site, Mirabel, Quebec J7J 2K8, Canada

Novartis Investigative Site, St-Charles-Borromée, Quebec J6E 6J2, Canada

Novartis Investigative Site, Cottbus, Sachsen 03050, Germany

Additional Information

Starting date: October 2011
Last updated: November 5, 2013

Page last updated: August 23, 2015

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