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

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: QVA149; Drug: Placebo to QVA149; Drug: Salbutamol/albuterol; Drug: Tiotropium; Drug: Placebo to tiotropium

Study type: Interventional

Funder types: Industry

Identifiers

NCT01490125

2011-000229-63 (EudraCT Number)

CQVA149A2322

Details and patient eligibility

About

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

Full 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.

Enrollment: 247 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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247 participants in 3 patient groups, including a placebo group

QVA149 + placebo to tiotropium

Experimental group

Description:

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.

Treatment:

Drug: QVA149

Drug: Salbutamol/albuterol

Drug: Placebo to tiotropium

Tiotropium + placebo to QVA149

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo to QVA149

Drug: Salbutamol/albuterol

Drug: Tiotropium

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo to QVA149

Drug: Salbutamol/albuterol

Drug: Placebo to tiotropium