Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease
This study will assess of the efficacy and safety of a once-daily, 50µg inhalation of NVA237
 in moderate to severe chronic obstructive pulmonary disease (COPD) patients over 26 weeks
 treatment.
Inclusion Criteria:

 -  Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior
 to initiation of any study-related procedure

 -  With moderate to severe stable COPD (Stage II or Stage III).

 -  Current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack-
 years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20
 years).

 -  Post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and
 post-bronchodilator FEV1/FVC < 0.7 at Visit 2 (Day -14) (post means: record FEV1 and
 FVC 45 min after administering ipratropium).

 -  Symptomatic patients, according to daily electronic diary data between Visit 2 (Day
 -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7
 days prior to Visit 3

 Exclusion Criteria:

 -  With a history of malignancy of any organ system (including lung cancer), treated or
 untreated, within the past 5 years whether or not there is evidence of local
 recurrence or metastases, with the exception of localized basal cell carcinoma of the
 skin.

 -  Patients with any history of asthma indicated by (but not limited to) a blood
 eosinophil count > 600/mm3 (at Visit 2) or onset of symptoms prior to age 40 years.
 Patients without asthma but who have a blood eosinophil count >600/mm3 at Visit 2 are
 excluded.

 -  Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless
 confirmed by imaging to be no longer active) or clinically significant bronchiectasis,
 sarcoidosis and interstitial lung disorder.

 -  Patients with lung lobectomy or lung volume reduction or lung transplantation.

 -  Patients with known history and diagnosis of α-1 antitrypsin deficiency.

 -  Patients who have had a COPD exacerbation that required treatment with antibiotics,
 systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to
 Visit 1 Patients who have had a respiratory tract infection within 6 weeks prior to
 Visit 1.

 Other protocol-defined inclusion/exclusion criteria may apply.