A Study to Investigate the Bronchodilatory Effect of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT00856193
- Lead Sponsor
- Novartis
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- Male or female aged greater than 40 years with COPD Current or ex-smokers
- Cardiac (heart) disorders, history of asthma, requiring oxygen therapy. Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description NVA237 50μg then placebo Placebo NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device. Placebo then NVA237 50μg Placebo Placebo 50 μg capsules followed by NVA237 50 μg capsules for inhalation once daily with Concept 1 device. NVA237 50μg then placebo NVA237 NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device. Placebo then NVA237 50μg NVA237 Placebo 50 μg capsules followed by NVA237 50 μg capsules for inhalation once daily with Concept 1 device.
- Primary Outcome Measures
Name Time Method Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14 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 Outcome Measures
Name Time Method 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 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 pre-dose (day 1) to the readings taken 0-12 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.
Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) Day 14 According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening , causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. See Adverse Events module for details.
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 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 pre-dose (day 1) to the readings taken 12-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate.
Trial Locations
- Locations (2)
Harrison Clinical Research Deutschland GmbH
🇩🇪Albrechtstrasse 14, Munich, Germany
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States