Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Using Salmeterol as Active Control

A 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control

This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

Inclusion Criteria:

Clinical diagnosis of moderate to severe Chronic Obstructive Pulmonary Disease (COPD) as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2006 Guidelines (mandatory) and including:

• Smoking history of at least 20 pack years
• Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% predicted and >or= 30% of predicted normal value
• Post-bronchodilator FEV1/FVC < 70%

("Post" defined as within 30 minutes of inhalation of 400 µg salbutamol)

Exclusion Criteria:

• Pregnant or nursing (lactating) women and women of child-bearing potential UNLESS they meet pre-specified definitions of post-menopausal or are using pre-specified acceptable methods of contraception
• Hospitalisation for COPD exacerbation in the 6 weeks prior to Visit 1 or during run-in
• Patients requiring oxygen therapy for chronic hypoxemia (typically >15h/day)
• Respiratory tract infection within 6 weeks prior to Visit 1 and during the run-in period
• Concomitant pulmonary disease
• Asthma history (eosinophils > 400/mm3; symptoms prior to age 40). Includes history of childhood asthma
• History of long QTc syndrome or QTc interval > 450 ms for males and >470 ms for females
• Patients who have a clinically significant condition or a clinically relevant laboratory abnormality
• History of reactions to sympathomimetic amines or inhaled medication
• Inability to use the dry powder devices or perform spirometry
• Irregular day/night, wake/sleep cycles, e.g. shift workers
• Certain medications for COPD and allied conditions such as long acting bronchodilators must not be used prior to Visit 1 and for a pre-specified minimum washout period
• Patients unable or unwilling to complete a patient diary

Other protocol-defined inclusion/exclusion criteria may apply.