A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo
- Conditions
- Health Condition 1: null- Chronic Obstructive Pulmonary Disease
- Registration Number
- CTRI/2009/091/000910
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 800
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Trough Forced Expiratory Volume in 1 Second (FEV1)Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method * George's Respiratory Questionnaire (SGRQ)Timepoint: 26 weeks;* Transition Dyspnea Index (TDI)Timepoint: 26 weeks