Study of Efficacy and Safety of NVA237 in Patients With Poorly Controlled Asthma

The study will assess efficacy and safety of NVA237 compared to placebo, in addition to
background therapy with LABA/ICS in patients with poorly controlled asthma.

Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed; Male and
female adult patients aged 18 to <75 years; Patients with a diagnosis of asthma (according
to GINA 2012) for a period of at least 5 years prior screening; The diagnosis of asthma
must have been made before the patient was 40; Increase in forced expiratory volume in 1
second (FEV1) of ≥ 12% and ≥ 200 mLs within 30 minutes after administration of 400 µg
salbutamol/360 µg albuterol (or equivalent dose); Pre-bronchodilator FEV1 of ≥ 50 and ≤
80% of the predicted normal value for the patient; Patients who qualify for treatment
(according to GINA 2012) and have been treated with a stable dose of a fixed dose inhaled
corticosteriod (ICS) and long-acting β2 agonist (LABA) combination for at least 4 weeks
prior to screening. Patient must be using a total daily dose of ICS of ≥800 μg/day of
budesonide of equivalent; All patients must be symptomatic with a mean ACQ-5 score ≥ 1.5
at Visit 101 and Visit 102; A documented history of one or more asthma exacerbations in
the previous 12 months that required either treatment with additional or increased dose of
systemic corticosteroids for at least 3 days, or an emergency room visit, or hospital
treatment, or intubation

Exclusion Criteria:

Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to
any of the following inhaled drugs, drugs of a similar class, or any component thereof:

Muscarinic antagonist agents, sympathomimetic amines, lactose or any of the other
excipients of the study drug, long and short acting beta-2 agonists, corticosteroids;
Women of child-bearing potential; Resting QTcF ≥ 450 ms (male) or ≥ 460 ms (female) at
Visit 101 (assessed by central reader) and at Visit 102 (assessed by investigator at the
site); Patients with a body mass index (BMI) of more than 40 kg/m2; Patients who have
clinically significant renal, cardiovascular (such as but not limited to unstable ischemic
heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction,
arrhythmia, neurological, endocrine, immunological, psychiatric, gastrointestinal,
hepatic, or hematological abnormalities which could interfere with the assessment of the
efficacy and safety of the study treatment; Patients with narrow-angle glaucoma,
symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe
renal impairment or urinary retention (BPH patients who are stable on treatment can be
considered); Patients who have had an asthma exacerbation that required either treatment
with additional or increased dose of systemic corticosteroids for at least 3 days, or an
emergency room visit, or hospital treatment, or intubation in the 6 weeks prior to
screening; Patients who have smoked or inhaled tobacco products within the 6 month period
prior to screening, or who have a smoking history of greater than 10 pack years (Note:10
pack years = 1 pack /day x 10 yrs., or ½ pack/day x 20 yrs.); Patients with a history of
chronic lung diseases other than asthma, including (but not limited to) chronic
obstructive pulmonary disease, bronchiectasis, sarcoidosis, interstitial lung disease,
cystic fibrosis, and tuberculosis (unless tuberculosis is confirmed as no longer active by
imaging); Patients on Maintenance Immunotherapy (desensitization) for allergies must have
been so for at least 3 months prior to run-in, and must be expected to remain unchanged
throughout the course of the study;