A 52-week treatment, randomized, double-blind, placebo-controlled, with open label tiotropium, parallel-group study to assess the efficacy, safety and tolerability of NVA237 in patients with chronic obstructive pulmonary disease

INTERVENTION: Product Name: NVA237 Product Code: NVA237 Pharmaceutical Form: Capsule, hard Current Sponsor code: NVA237 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Inhalation use Trade Name: Spiriva Product Name: Spiriva Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: tiotropium bromide Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 18‐ CONDITION: Chronic Obstructive Pulmonary Disease (COPD) ; MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD PRIMARY OUTCOME: Main Objective: To confirm that NVA237 50µg o.d. (delivered via a SDDPI) vs placebo significantly increases mean 24 h post‐dose (trough) FEV1 following 12 weeks of treatment in patients with moderate to severe COPD (GOLD Guidelines 2008) Primary end point(s): Mean trough FEV1 after 12 weeks treatment imputed with LOCF Secondary Objective: Key: ; • evaluate the effect of NVA237 (50µg o.d.) vs placebo on breathlessness measured using the Transition Dyspnea Index (TDI) after 26 weeks treatment.; • evaluate the effect of NVA237 (50µg o.d.) vs placebo on the total score of the St George’s Respiratory Questionnaire (SGRQ) after 52 weeks treatment.; ; Important secondary objectives/variables; • evaluate the effect of NVA237 (50µg o.d.) vs placebo on time to first COPD exacerbation during 52 weeks treatment.; • evaluate the effect of NVA237 (50µg o.d.) vs placebo on daily rescue medication use (number of puffs) over 52 weeks.; ; Note: Additionnal secondary comparisons are outlined in the protocol; ; Additional safety assessment:; • assess the safety of NVA237 by following up on all patients’ life status (survival information) and cause of death (if applicable) during 56 weeks (52 weeks randomized treatment period plus 4 weeks follow up). INCLUSION CRITERIA: 1. Male or female adults aged =40 years, who have signed an Informed Consent Form prior to initiation of any study‐related procedure. 2. Patients with moderate to severe stable COPD (Stage II or Stage III) according to the (GOLD Guidelines 2008). 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 etc.) 4. Patients with a post‐bronchodilator FEV1 =30% and < 80% of the predicted normal, and post‐bronchodilator FEV1/FVC < 0.7 at Visit 2 (day ‐14) 5. Patients, according to daily electronic diary data between Visit 2 (‐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 (For scoring information see Section 7.4.3.1.) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this ag