Phase 2
Completed N=33
A Study to Investigate the Bronchodilatory Effect of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT00856193 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
May 2011
Primary outcomePrimary: Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14 — 1.827; 1.664 Liters
Summary
This study was intended to assess how well inhaled NVA237 opens up the airways of patients with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14 |
1.827; 1.664 | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14 |
1.879; 1.714 | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14 |
1.776; 1.615 | — |
| SECONDARY Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) |
2; 4; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female aged greater than 40 years with COPD Current or ex-smokers
Exclusion Criteria
- Cardiac (heart) disorders, history of asthma, requiring oxygen therapy. Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00856193). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.