NVA237 Versus Placebo 12-week Efficacy Study
NVA237 Versus Placebo 12-week Efficacy Study
The study serves to determine whether the treatment of patients with stable, symptomatic
 Chronic Obstructive Pulmonary Disease (COPD) with the investigational drug NVA237 is
 efficient and safe. The efficacy and safety of the drug will be tested against a placebo
 treatment.

 The primary criterion to assess efficacy will be the difference between the serial lung
 function measurements of patients who have been treated for 12 weeks with NVA237 versus those
 that have received placebo treatment for 12 weeks. A serial lung function measurement (FEV1
 testing) will be conducted and the "area under the curve" will be the measure for the ability
 to breathe.
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.