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Trial record 1 of 1 for:    NCT01490125.
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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

November 15, 2011
May 21, 2013
October 2011
August 2012   (final data collection date for primary outcome measure)
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)
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)
Complete list of historical versions of study NCT01490125 on ClinicalTrials.gov Archive Site
  • 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
  • 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 secone (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
Not Provided
Not Provided
 
The Effect of QVA149 on Dyspnea in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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

This study will assess the safety and efficacy of QVA on patient-reported dyspnea in moderate to severe Chronic Obstructive Pulmonary Disease (COPD) patients.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • 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.
  • 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
  • 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
  • Experimental: QVA149
    Intervention: Drug: QVA149
  • Active Comparator: Tiotropium
    Intervention: Drug: Tiotropium
  • 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)
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
246
August 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Germany,   Spain,   United Kingdom
 
NCT01490125
CQVA149A2322, 2011-000229-63
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Study Director: Novartis Phamaceuticals Novartis Phamaceuticals
Novartis
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP