Comparison of Safety and Efficacy of the Combination Product QVA149A Against the Concurrent Administration of the Individual Components, QAB149 and NVA237, in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BEACON)

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: NVA237; Drug: Placebo; Drug: QAB149; Drug: QVA149

Study type: Interventional

Funder types: Industry

Identifiers

NCT01529632

CQVA149A2326

2011-006050-91 (EudraCT Number)

Details and patient eligibility

About

The study assessed the safety and efficacy of the fixed combination product QVA149 versus the component products QAB149 and NVA237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (COPD).

Full description

The study assessed the safety and efficacy of the fixed combination product QVA149 versus the component products QAB149 and NVA237, administered concurrently, in patients that have moderate to severe chronic obstructive pulmonary disease (COPD).

Enrollment: 193 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female adults aged ≥ 40 yrs
• Smoking history of at least 10 pack years
• Diagnosis of COPD (moderate to severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2010)
• Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

Exclusion criteria

• Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
• Patients with concomitant pulmonary disease
• Patients with a history of asthma
• Any patient with lung cancer or a history of lung cancer
• Patients with a history of certain cardiovascular co-morbid conditions
• Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
• Patients in the active phase of a supervised pulmonary rehabilitation program
• Patients contraindicated for inhaled anticholinergic agents and β2 agonists

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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193 participants in 2 patient groups

QVA149

Experimental group

Description:

QVA149 plus placebo once daily for 28 days.

Treatment:

Drug: Placebo

Drug: QVA149

QAB149 + NVA237

Active Comparator group

Description:

Indacaterol maleate (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.

Treatment:

Drug: NVA237

Drug: QAB149