Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

• Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve (AUC) 5 Minutes-12 Hours at Day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  Spirometry testing was performed in accordance with American Thoracic Society standards. FEV1 was assessed at 5, 15, 30 minutes, 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post dose on Day 7. Standardized (with respect to time) AUC (5 minutes-12 hours) for FEV1 on day 7 was calculated using the trapezoidal rule. Least square means are based on the Analysis of Covariance: FEV1 AUC = sequence effect + patient (sequence) + period + treatment + baseline FEV1 (period) + error.
• Number of Participants With Adverse Events, Serious Adverse Events and Discontinuations Due to Adverse Events [ Time Frame: 47 days ] [ Designated as safety issue: No ]
  Additional information about adverse events can be found in the Adverse Event Section.

• Trough FEV1, FEV1 and Forced Vital Capacity (FVC), standardized FEV1 Area Under Curve (AUC), Inspiratory Capacity (IC); rescue medication usage [ Time Frame: 7 days ] [ Designated as safety issue: No ]
• Safety assessments will include vital signs, electrocardiograms (ECG) and adverse events (AEs). [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.

• Drug: indacaterol/glycopyrrolate
  Inhalation capsule indacaterol/glycopyrrolate 300/50 μg inhaled once daily via a single dose dry powder inhaler for 7 days.
  Other Name: QVA149
• Drug: indacaterol
  Inhalation capsule indacaterol supplied as 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
  Other Name: QAB149
• Drug: placebo
  Placebo inhalation capsules inhaled once daily via a single dose dry powder inhaler for 7 days.

• Experimental: indacaterol/glycopyrrolate 300/50 μg
  One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
  Intervention: Drug: indacaterol/glycopyrrolate
• Active Comparator: indacaterol 600 μg
  Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
  Intervention: Drug: indacaterol
• Active Comparator: indacaterol 300 μg
  One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
  Intervention: Drug: indacaterol
• Placebo Comparator: placebo
  Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
  Intervention: Drug: placebo

Inclusion Criteria:

1. Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
2. Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
3. Patients who have smoking history of at least 10 pack years.
4. Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and < 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity (FVC) <0.70.

Exclusion Criteria:

1. Pregnant or nursing women, or women of child-bearing potential, regardless of whether or not sexually active if they are not using acceptable methods of contraception.
2. Patients requiring long term oxygen therapy (> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to screening.
3. Patients who have had a respiratory tract infection within 6 weeks prior to screening.
4. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
5. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 400/mm3.
6. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
7. Patients with uncontrolled Type I and Type II diabetes.
8. History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
9. Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
10. Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at screening is prolonged (>450 ms for males or >470 ms for females).
11. Patients with a history of untoward reactions to sympathomimetic amines, inhaled medication or any component thereof, or any of the study drugs or drugs with similar chemical structures.

Other protocol-defined inclusion/exclusion criteria may apply.