QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) (ILLUMINATE)

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo to fluticasone/salmeterol; Drug: indacaterol and glycopyrronium (QVA149); Drug: fluticasone/salmeterol; Drug: Placebo to indacaterol and glycopyrronium (QVA149)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01315249

CQVA149A2313

2010-023621-37 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.

Enrollment: 523 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Smoking history of at least 10 pack years
• Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2009)
• Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) >40% and < 80% of the predicted normal value and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <70%

Exclusion criteria

• Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last year.
• Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
• 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 (within last 5 years)
• Patients with a history of certain cardiovascular co-morbid conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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523 participants in 2 patient groups

QVA149

Experimental group

Description:

Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.

Treatment:

Drug: indacaterol and glycopyrronium (QVA149)

Drug: Placebo to fluticasone/salmeterol

fluticasone/salmeterol

Active Comparator group

Description:

Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Treatment:

Drug: Placebo to indacaterol and glycopyrronium (QVA149)

Drug: fluticasone/salmeterol