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 (CNVA237A2304)
- Conditions
- chronic obstructive pulmonary diseaseCOPD10038716
- Registration Number
- NL-OMON34669
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
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
• Oxygen therapy.
• Lower airway infection in the past 6 weeks.
• Bronchial asthma.
• a1-antitrypsin deficiency.
• Other relevant pulmonary diseases.
• Use of ceratin COPD medications (see protocol for details).
• Pregnancy and breast feeding. Inadequate contraception, if relevant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pulmonary function parameters at trough.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Transition Dyspnea Index (TDI), St George*s Respiratory Questionnaire<br /><br>(SGRQ),time to 1st exacerbation, number of exacerbations, use of rescue<br /><br>medication, all measurements of pulmonary function parameters , signs and<br /><br>symptoms, adverse events.</p><br>