Efficacy and Safety Study of Indacaterol Maleate/Glycopyrronium Bromide in Chronic Obstructive Pulmonary Disease (COPD) Patients.

Inclusion Criteria:

- Male or female adults aged ≥40 yrs

- Smoking history of at least 10 pack years

- Diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) as classified by the
Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2015)

- Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)< 80% and ≥ 30% of the
predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

- Modified Medical Research Council questionnaire grade of 2 or higher

Exclusion Criteria:

- 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

- Patients with a history of certain cardiovascular co-morbid conditions

- Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency

- Patients in the active phase of a supervised pulmonary rehabilitation program

- Patients contraindicated for inhaled anticholinergic agents and β2 agonists

- Other protocol-defined inclusion/exclusion criteria may apply