Study of Indacaterol Dosed in the Evening in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Inclusion criteria:

• Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
• Co-operative outpatients with a diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the Global initiative for chronic obstructive lung disease (GOLD) Guidelines, 2006) and:
• Smoking history of at least 20 pack years
• Post-bronchodilator FEV1 < 80% and ≥30% of the predicted normal value
• Post-bronchodilator FEV1/forced vital capacity (FVC) < 70%

Exclusion criteria:

• Pregnant or lactating females
• Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
• Patients requiring long term oxygen therapy (>15 h a day)
• Patient who have had a respiratory tract infection 6 weeks prior to V2 (with further criteria)
• Patients with concomitant pulmonary disease, pulmonary tuberculosis, or clinically significant bronchiectasis
• Patients with history of asthma (with further criteria)
• Patients with Type I or uncontrolled type II diabetes.
• Patients who have clinically relevant laboratory abnormalities or a clinically significant abnormality
• Any patient with active cancer or a history of cancer with less than 5 years disease free survival time
• Patient with a history with long QT syndrome or whose QTc interval is prolonged
• Patients with a hypersensitivity to any of the study drugs or drugs with similar chemical structure
• Patients who have had treatment with an investigational drug (with further criteria)
• Patients who have had live attenuated vaccination within 30 days prior to Visit 2, or during run-in period
• Patients with known history of non compliance to medication
• Patients unable to satisfactorily use a dry powder inhaler device or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria may apply