To Determine the Relationship Between Baseline Reversibility and the Efficacy of Indacaterol (REVERBREZ)

Novartis

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Indacaterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01272362

CQAB149BFR01

2010-022831-12 (EudraCT Number)

Details and patient eligibility

About

In this 5-months study, the response of patients to salbutamol at baseline will be compared with their response to treatment with indacaterol.

Enrollment: 625 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2009) and:

  1. Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value
  2. Post-bronchodilator FEV1/FVC (forced vital capacity) <70%

• Smoking history of at least 10 pack-years

Exclusion criteria

• Patients who have had a COPD exacerbation in the 6 weeks prior to screening
• Patients who have had a respiratory tract infection within 4 weeks prior to screening
• Patients with concomitant pulmonary disease
• Patients with a history of asthma
• Patients with diabetes Type I or uncontrolled diabetes Type II
• Any patient with lung cancer or a history of lung cancer
• Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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625 participants in 1 patient group

Indacaterol

Experimental group

Treatment:

Drug: Indacaterol