A randomized, double-blind, placebo-controlled, 2-period, cross-over study to assess the efficacy and safety of differing doses of NVA237 administered either once daily or twice daily, in patients with moderate to severe chronic obstructive pulmonary disease (COPD)
- Conditions
- chronic obstructive pulmonary diseaseCOPD10038716
- Registration Number
- NL-OMON34643
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 58
1. Male or female adults aged 40 years and above.
2. Moderate to severe stable COPD (Stage II or Stage III) according to the (GOLD Guidelines 2008).
3. Smoking history of at least 10 pack years.
4. Post-bronchodilator FEV1 >30% and < 80% of the predicted normal.
5. FEV1/FVC ratio <70% (post bronchodilation).
• Lower airway infection in the past 4 weeks.
• Bronchial asthma.
• Type I and uncontrolled type II diabetes.
• a1-antitrypsin deficiency.
• Other relevant pulmonary diseases.
• Contra-indications for anticholinergics.
• Use of ceratin COPD and other medications (see protocol for details).
• Vaccination with live or inactivated vaccines in the past 30 and 2 days resp.
• Longterm oxygen therapy.
• Pregnancy and breast feeding. Inadequate contraception, if relevant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Relationship of incremental doses of NVA237 q.d. and b.i.d. and their effect on<br /><br>trough FEV1 after 28 days of treatment, as defined by the percentage of the<br /><br>maximal effect that each dose achieves in relation to the maximal effect of<br /><br>NVA237. (Trough is defined as the mean of FEV1<br /><br>measurements at 23 h 15 min and 23 h 45 min post morning dose).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Use of rescue medication, FEV1 (AUC 0-24 h and shorter intervals, peak and 12<br /><br>h), FVC, safety.</p><br>