Efficacy and Safety Study of Indacaterol Maleate/Glycopyrronium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients.

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo (umeclidinium/vilanterol ); Drug: QVA149; Drug: Umeclidinium/vilanterol; Drug: Placebo (QVA149)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02487498

CQVA149A2350

Details and patient eligibility

About

The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.

Enrollment: 355 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female adults aged ≥40 yrs
• Smoking history of at least 10 pack years
• Diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2015)
• Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)< 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%
• Modified Medical Research Council questionnaire grade of 2 or higher

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: Crossover Assignment

Masking: Double Blind

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355 participants in 2 patient groups

QVA149

Experimental group

Description:

QVA149 capsules for inhalation, delivered via QVA149 SDDPI

Treatment:

Drug: Placebo (umeclidinium/vilanterol )

Drug: QVA149

Umeclidinium/vilanterol

Experimental group

Description:

Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler

Treatment:

Drug: Umeclidinium/vilanterol

Drug: Placebo (QVA149)