NVA237 Versus Placebo 12-week Efficacy Study

Inclusion criteria:

1. Patients with stable, symptomatic Chronic Obstructive Pulmonary Disease (COPD) with
airflow obstruction of level 2 and 3 according to the current Global initiative for
chronic Obstructive Lung Disease (GOLD) strategy (2011).

2. Patients with Forced Expiratory Volume in one second (FEV1) ≥ 30% and <80 % of the
predicted normal, and FEV1/ Forced Vital Capacity (FVC) < 0.70 when measured 45 min
after the inhalation of 84 µg ipratropium bromide.

3. Current or ex-smokers with at least 10 cigarette pack years smoking history.

Exclusion criteria:

1. Patients with a history of long QT syndrome, with a prolonged QTc measured during
screening, or patients who have a clinically significant ECG abnormality at
screening.

2. History of malignancy of any organ system (other than localized basal cell carcinoma
of the skin), treated or untreated, within the past 5 years, regardless of whether
there is evidence of local recurrence or metastases.

3. Pregnant or nursing (lactating) women. Women of childbearing potential unless using
an effective method of contraception.

4. Patients who in the judgment of the investigator, would be at potential risk if
enrolled into the study.

5. Patients who have a clinically significant concomitant disease at screening,
including but not limited to clinically significant laboratory abnormalities,
clinically significant renal, cardiovascular, neurological, endocrine, immunological,
psychiatric, gastrointestinal, hepatic, or hematological abnormalities, or with
uncontrolled diabetes, which could interfere with the assessment of the efficacy and
safety of the study treatment.

6. Patients with a body mass index (BMI) of more than 40 kg/m2.

7. Patients contraindicated for treatment with, or having a history of reactions/
hypersensitivity to anticholinergic agents, long and short acting beta-2 agonists, or
sympathomimetic amines.

8. Patients with any history of asthma, with onset of symptoms prior to age 40 years, or
patients with a high blood eosinophil count during screening.

Other protocol-defined inclusion/exclusion criteria may apply.