A Study to Assess the Long-term Safety of QVA149 (ENLIGHTEN)

Novartis

Status and phase

Completed

Phase 3

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: QVA149

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

2009-013235-38 (EudraCT Number)

CQVA149A2307

Details and patient eligibility

About

The study is designed to provide long-term safety data for QVA149 in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Enrollment

339 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 COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
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