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The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01490125

Last Updated: 2013-12-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

247 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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COPD Dyspnea QVA149 tiotropium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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QVA149 + placebo to tiotropium

Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.

Group Type EXPERIMENTAL

QVA149

Intervention Type DRUG

QVA149 110/50 μg hard non-gelatin capsule, inhalation/blister once a day via SDDPI

Placebo to tiotropium

Intervention Type DRUG

Placebo 0 mg hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device

Salbutamol/albuterol

Intervention Type DRUG

salbutamol/albuterol (containing CFC-free propellant -HFA 134a) inhaler used as rescue medication when needed.

Tiotropium + placebo to QVA149

Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.

Group Type ACTIVE_COMPARATOR

Tiotropium

Intervention Type DRUG

Tiotropium 18 ug hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device

Placebo to QVA149

Intervention Type DRUG

Placebo 0 mg hard non-gelatin capsule, inhalation/ blister once a day via SDDPI

Salbutamol/albuterol

Intervention Type DRUG

salbutamol/albuterol (containing CFC-free propellant -HFA 134a) inhaler used as rescue medication when needed.

Placebo

Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.

Group Type PLACEBO_COMPARATOR

Placebo to QVA149

Intervention Type DRUG

Placebo 0 mg hard non-gelatin capsule, inhalation/ blister once a day via SDDPI

Placebo to tiotropium

Intervention Type DRUG

Placebo 0 mg hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device

Salbutamol/albuterol

Intervention Type DRUG

salbutamol/albuterol (containing CFC-free propellant -HFA 134a) inhaler used as rescue medication when needed.

Interventions

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QVA149

QVA149 110/50 μg hard non-gelatin capsule, inhalation/blister once a day via SDDPI

Intervention Type DRUG

Tiotropium

Tiotropium 18 ug hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device

Intervention Type DRUG

Placebo to QVA149

Placebo 0 mg hard non-gelatin capsule, inhalation/ blister once a day via SDDPI

Intervention Type DRUG

Placebo to tiotropium

Placebo 0 mg hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device

Intervention Type DRUG

Salbutamol/albuterol

salbutamol/albuterol (containing CFC-free propellant -HFA 134a) inhaler used as rescue medication when needed.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Brussels, , Belgium

Site Status

Novartis Investigative Site

Gilly, , Belgium

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Novartis Investigative Site

Jambes, , Belgium

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Novartis Investigative Site

Jette, , Belgium

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Novartis Investigative Site

Leuven, , Belgium

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Novartis Investigative Site

Liège, , Belgium

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Novartis Investigative Site

Ostend, , Belgium

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Novartis Investigative Site

Wavre, , Belgium

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Novartis Investigative Site

Burlington, Ontario, Canada

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Novartis Investigative Site

Mississauga, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Novartis Investigative Site

Laval, Quebec, Canada

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Mirabel, Quebec, Canada

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Novartis Investigative Site

Saint-Charles-Borromée, Quebec, Canada

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Novartis Investigative Site

Berlin, Germany, Germany

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Novartis Investigative Site

Leipzig, Germany, Germany

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Novartis Investigative Site

Mainz, Germany, Germany

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Potsdam, Germany, Germany

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Novartis Investigative Site

Cottbus, Saxony, Germany

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Aschaffenburg, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Frankfurt, , Germany

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Halle, , Germany

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Hanover, , Germany

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Leipzig, , Germany

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Novartis Investigative Site

Leipzig, , Germany

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Novartis Investigative Site

Leipzig, , Germany

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Novartis Investigative Site

Potsdam, , Germany

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Novartis Investigative Site

Rheine, , Germany

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Novartis Investigative Site

Rüdersdorf, , Germany

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Novartis Investigative Site

Málaga, Andalusia, Spain

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Novartis Investigative Site

Mérida, Badajoz, Spain

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Novartis Investigative Site

Badalona, Barcelona, Spain

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Novartis Investigative Site

Ponferrada, Leon, Spain

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Novartis Investigative Site

Madrid, Madrid, Spain

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Novartis Investigative Site

Salford, Manchester, United Kingdom

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Novartis Investigative Site

Bradford, , United Kingdom

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Novartis Investigative Site

Glasgow, , United Kingdom

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Novartis Investigative Site

Newcastle upon Tyne, , United Kingdom

Site Status

Novartis Investigative Site

Portsmouth, , United Kingdom

Site Status

Countries

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Belgium Canada Germany Spain United Kingdom

References

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Mahler DA, Decramer M, D'Urzo A, Worth H, White T, Alagappan VK, Chen H, Gallagher N, Kulich K, Banerji D. Dual bronchodilation with QVA149 reduces patient-reported dyspnoea in COPD: the BLAZE study. Eur Respir J. 2014 Jun;43(6):1599-609. doi: 10.1183/09031936.00124013. Epub 2013 Oct 31.

Reference Type DERIVED
PMID: 24176997 (View on PubMed)

Other Identifiers

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2011-000229-63

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQVA149A2322

Identifier Type: -

Identifier Source: org_study_id