A Randomized, Double-blind, Placebo-controlled, Multi-center, Two-period Crossover Study to Investigate the Bronchodilatory Effect of 50 µg NVA237 Inhaled Once Daily in Patient With Chronic Obstructive Pulmonary Disease (COPD).
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- Novartis
- Enrollment
- 33
- Locations
- 2
- Primary Endpoint
- Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
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
Arms & Interventions
Placebo then NVA237 50μg
Placebo 50 μg capsules followed by NVA237 50 μg capsules for inhalation once daily with Concept 1 device.
Intervention: Placebo
Placebo then NVA237 50μg
Placebo 50 μg capsules followed by NVA237 50 μg capsules for inhalation once daily with Concept 1 device.
Intervention: NVA237
NVA237 50μg then placebo
NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device.
Intervention: Placebo
NVA237 50μg then placebo
NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device.
Intervention: NVA237
Outcomes
Primary Outcomes
Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14
Time Frame: From Day 1 to 0-24 hours after drug administration on Day 14
Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from predose (day 1) to the readings taken 0-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.
Secondary Outcomes
- Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14(From day 1 to 0 -12 hours after drug administration on Day 14)
- Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs)(Day 14)
- Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14(From Day 1 to 12 hours-24 hours after drug administration on Day 14)