To Determine the Relationship Between Baseline Reversibility and the Efficacy of Indacaterol

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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