Phase 2
Completed N=83
Efficacy and Safety of Four Doses of Glycopyrronium Bromide (NVA237) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), in Comparison to an Active Comparator Tiotropium
Source: ClinicalTrials.gov NCT00501852 ↗Enrolled (actual)
83
Serious AEs
0.3%
Results posted
Jan 2011
Primary outcomePrimary: Trough Forced Expiratory Volume in 1 Second (FEV1) Following 7 Days of Treatment — 1.317; 1.333; 1.374; 1.385 Liters
Summary
This study will assess the efficacy and safety of glycopyrronium bromide (NVA237) in patients with stable COPD, in comparison to an active comparator.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in 1 Second (FEV1) Following 7 Days of Treatment |
1.317; 1.333; 1.374; 1.385; 1.243; 1.370 | — |
| SECONDARY Least Squares Means of FEV1 (L) at Day 1, by Timepoint |
1.25; 1.24; 1.24; 1.24; 1.24; 1.25 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
- Patients with moderate to severe COPD according to the Gold Guidelines (2006).
- Patients who have smoking history of at least 10 pack years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
- Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥30% and 400/mm3
- Onset of symptoms prior to age 40 years.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00501852). 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.