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The Effect of QVA149 on Dyspnea in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BLAZE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01490125
First received: November 15, 2011
Last updated: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

This study will assess the safety and efficacy of QVA on patient-reported dyspnea in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: QVA149
Drug: Tiotropium
Drug: Placebo
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • The improvement in TDI (total transient dyspnea index) score after treatment with QVA149 compared to placebo [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    TDI is part of the BDI/TDI questionnaire where the patient will be asked to indicate whether they have improved or deteriorated since their baseline dypsnea index (BDI)


Secondary Outcome Measures:
  • The improvement in TDI score after treatment with QVA149 compared to tiotropium [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    TDI is part of the BDI/TDI questionnaire where the patient will be asked to indicate whether they have improved or deteriorated since their baseline dypsnea index (BDI)

  • Forced expiratory volume in one second (FEV1) area under the curve (AUC)(0-4hrs) after 6 weeks treatment with QVA149 compared to placebo and tiotropium [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The FEV1 will measure the maximum amount of air a patient can blow out of their lungs in 1 second at several time-points from 0-4 hours.

  • Forced vital capacity (FVC) AUC (0-4 hrs) after treatment with QVA149 compared to placebo and tiotropium [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    FVC is the total amount of air that can be exhaled by the patient after a full inhalation. The FVC will be repeated over several time-points from 0-4 hours.

  • Mean change from baseline in Capacity of Daily Living during the Morning (CDLM) Questionnaire [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The CDLM is a 7 question questionnaire that will be completed by the patient every morning during the study

  • Mean change from baseline in number of puffs of rescue medication [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The number of puffs of rescue medication taken by the patient will be collected each day during the study

  • Compare improvement in CDLM Questionnaire to FEV1 AUC 0-4 hrs. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    The results of the CDLM questionnaire will be compared to the results of the FEV1 AUC 0-4 hours

  • Safety and tolerability [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Safety and tolerability will be evaulated from laboratory tests and ECG results, vital signs and any adverse events


Enrollment: 246
Study Start Date: October 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QVA149 Drug: QVA149
Patients will undergo 3 treatment periods. Each treatment period will be 6 weeks in duration. Each treatment period will be separated by a 2 week wash out period.
Active Comparator: Tiotropium Drug: Tiotropium
Patients will undergo 3 treatment periods. Each treatment period will be 6 weeks in duration. Each treatment period will be separated by a 2 week wash out period
Placebo Comparator: Placebo to QVA149 and Placebo to Tiotropium
Eligible patients will randomly undergo treatment with once-daily placebo to QVA149 and tiotropium during 1 treatment period (6 weeks)
 Drug: Placebo
Patients will undergo 3 treatment periods. Each treatment period will be 6 weeks in duration. Each treatment period will be separated by a 2 week wash out peri

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with moderate to severe chronic obstructive pulmonary disease
  • Smoking history of 10 pack years
  • Post-bronchodilator FEV1 between 30 - 80%
  • Patients must be able to use computer mouse and display

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/COPD
  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490125

  Hide Study Locations
Locations
Belgium
Novartis Investigative Site
Bruxelles, Belgium, 1000
Novartis Investigative Site
Gilly, Belgium, 6060
Novartis Investigative Site
Jambes, Belgium, 5100
Novartis Investigative Site
Jette, Belgium, 1090
Novartis Investigative Site
Leuven, Belgium, 3000
Novartis Investigative Site
Liege, Belgium, 4000
Novartis Investigative Site
Oostende, Belgium, 8400
Novartis Investigative Site
Wavre, Belgium, 1301
Canada, Ontario
Novartis Investigative Site
Burlington, Ontario, Canada, L7N 3V2
Novartis Investigative Site
Mississauga, Ontario, Canada, L5M 2V8
Novartis Investigative Site
Toronto, Ontario, Canada, M5G1N8
Novartis Investigative Site
Toronto, Ontario, Canada, M6H 3M2
Canada, Quebec
Novartis Investigative Site
Laval, Quebec, Canada, H7S 2M5
Novartis Investigative Site
Mirabel, Quebec, Canada, J7J 2K8
Novartis Investigative Site
St-Charles-Borromée, Quebec, Canada, J6E 6J2
Germany
Novartis Investigative Site
Cottbus, Sachsen, Germany, 03050
Novartis Investigative Site
Aschaffenburg, Germany, 63739
Novartis Investigative Site
Berlin, Germany, 13156
Novartis Investigative Site
Berlin, Germany, 10789
Novartis Investigative Site
Berlin, Germany, 12203
Novartis Investigative Site
Berlin, Germany, 12099
Novartis Investigative Site
Frankfurt, Germany, 60389
Novartis Investigative Site
Halle, Germany, 06108
Novartis Investigative Site
Hannover, Germany, 30317
Novartis Investigative Site
Leipzig, Germany, 04357
Novartis Investigative Site
Leipzig, Germany, 04103
Novartis Investigative Site
Leipzig, Germany, 04207
Novartis Investigative Site
Leipzig, Germany, 04275
Novartis Investigative Site
Mainz, Germany, D-55101
Novartis Investigative Site
Potsdam, Germany, 14478
Novartis Investigative Site
Potsdam, Germany, 14467
Novartis Investigative Site
Rheine, Germany, 48431
Novartis Investigative Site
Rüdersdorf, Germany, 15562
Spain
Novartis Investigative Site
Malaga, Andalucia, Spain, 29010
Novartis Investigative Site
Mérida, Badajoz, Spain, 06800
Novartis Investigative Site
Badalona, Barcelona, Spain, 08914
Novartis Investigative Site
Ponferrada, Leon, Spain, 24400
Novartis Investigative Site
Madrid, Spain, 28007
United Kingdom
Novartis Investigative Site
Salford, Manchester, United Kingdom, M6 8HD
Novartis Investigative Site
Bradford, United Kingdom, BD9 6RJ
Novartis Investigative Site
Glasgow, United Kingdom, G11 6NT
Novartis Investigative Site
Newcastle-upon-Tyne, United Kingdom, NE7 7DN
Novartis Investigative Site
Portsmouth, United Kingdom, PO6 3AD
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Phamaceuticals Novartis Phamaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01490125     History of Changes
Other Study ID Numbers: CQVA149A2322, 2011-000229-63
Study First Received: November 15, 2011
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Ethics Review Committee
Canada: Health Canada
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Spain: Ministry of Health and Ministry of Health and Consumption
Spain: Comite Etico de Investigacion Clinica
Spain: Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by Novartis:
COPD
Dyspnea
QVA149
tiotropium

Additional relevant MeSH terms:
Dyspnea
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Tiotropium
Parasympatholytics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013