A 26-week Treatment, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of NVA237 in Patients With Chronic Obstructive Pulmonary Disease

ovartis Healthcare Pvt Ltd0 个研究点目标入组 800 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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 postbronchodilator
•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.

•1.Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
•2.Patients with concomitant pulmonary disease
•3.Patients with a history of asthma
•4.Any patient with lung cancer or a history of lung cancer
•5.Patients with a history of certain cardiovascular comorbid conditions
•6.Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
•7.Patients in the active phase of a supervised pulmonary rehabilitation program
•8.Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents Other protocol-defined inclusion/exclusion criteria may apply

发起方

ovartis Healthcare Pvt Ltd