To asses the Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 450

Inclusion Criteria

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

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

3.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).

4.Post-bronchodilator FEV1 greater than equal to 30percent and less than 80percent of the predicted normal, and post-bronchodilator FEV1/FVC lesserthan 0.7 at Visit 2 (Day -14) (post means: record FEV1 and FVC 45 min after administering ipratropium).

5.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

1.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.

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

3.Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by imaging to be no longer active) or clinically significant bronchiectasis, sarcoidosis and interstitial lung disorder.

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

5.Patients with known history and diagnosis of Î±-1 antitrypsin deficiency.

6.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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Trough FEV1 following 12 weeks of treatment.Timepoint: 12 weeks

Secondary Outcome Measures

Name	Time	Method
1.The total score of the St Georges Respiratory Questionnaire (SGRQ) <br/ ><br>2.â?¢Breathlessness measured using the Transition Dyspnea Index (TDI) after 12 and 26 weeks treatment. <br/ ><br>3.Daily rescue medication use (number of puffs)Timepoint: 1. 12 to 26 weeks <br/ ><br>2.Visit 7 (12 weeks), Visit 10 (26 weeks) and baseline dyspnea index (BDI) at Visit 3. <br/ ><br>3.Over 26 weeks. <br/ ><br>