A Study to Investigate the Bronchodilatory Effect of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: Placebo
* Drug: NVA237


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo then NVA237 50μg<br>Placebo 50 μg capsules followed by NVA237 50 μg capsules for inhalation once daily with Concept 1 device. | Drug: Placebo<br>* Matching placebo capsules were supplied for inhalation once daily with Concept 1 device.<br>Drug: NVA237<br>* NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device.<br>|
| Experimental: NVA237 50μg then placebo<br>NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device. | Drug: Placebo<br>* Matching placebo capsules were supplied for inhalation once daily with Concept 1 device.<br>Drug: NVA237<br>* NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours 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. | From Day 1 to 0-24 hours after drug administration on Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours 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. | From day 1 to 0 -12 hours after drug administration on Day 14 | 
| Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours 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. | From Day 1 to 12 hours-24 hours after drug administration on Day 14 | 
| Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) | 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. | Day 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Bronchodilator