Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease
Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease
This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when
 combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients
 with chronic obstructive pulmonary disease (COPD).
Inclusion Criteria:

 -  Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as
 classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD)
 Guidelines, 2007) and:

 -  Smoking history of at least 10 pack-years

 -  Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30%
 of the predicted normal value

 -  Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

 Exclusion Criteria:

 -  Patients who have received systemic corticosteroids and/or antibiotics and/or was
 hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the
 run-in period

 -  Patients who have had a respiratory tract infection within 6 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 applied to the study.