Safety and Tolerability of 28 Days Treatment With Glycopyrronium Bromide (NVA237) (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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This study assessed the safety/tolerability of 28 days of treatment with NVA237 100 µg and 200 µg once a day, compared to placebo in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD).

Official Title
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A Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-center Study, to Assess the Safety and Tolerability of 28 Days Treatment With NVA237 (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: NVA237 100 µg
* Drug: Placebo
* Drug: NVA237 200 µg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female adults aged 40 years or older Patients with moderate to severe COPD according to the GOLD Guidelines (2006) Patients who have smoking history of at least 10 pack years Patients with a post-bronchodilator Forced Expiratory Volume in One Second (FEV1) equal or greater than 30% of the predicted normal value and less than 80% of the predicted normal value, and post-bronchodilator FEV1/FVC less than 0.7 at visit 2 Written informed consent by the patient prior to initiation of any study-related procedure Exclusion Criteria: Patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to visit 1 or during the screening period (up to visit 3). Patients who have had a respiratory tract infection within 6 weeks prior to visit 1 or during the screening period (up to visit 3). Patients with a history of asthma indicated by (but not limited to): Blood eosinophil count > 400/mm3, onset of symptoms prior to age 40 years. Patients with a history of long QT syndrome or whose QTc measured at visit 1 is prolonged (more than 440 ms for males or more than 460 ms for females). Patients with a history of untoward reactions to sympathomimetic amines or inhaled medication or any component thereof. Patients who, in the judgment of the investigator have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia, narrow-angle glaucoma, symptomatic prostatic hyperplasia, bladder-neck obstruction or moderate to severe renal impairment that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NVA237 100 µg<br> | Drug: NVA237 100 µg<br>* Dry powder inhalation once a day for up to 28 days<br>* Other names: Glycopyrronium Bromide;|
| Experimental: NVA237 200 µg<br> | Drug: NVA237 200 µg<br>* Dry powder inhalation once a day for up to 28 days<br>* Other names: Glycopyrronium Bromide;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo to NVA237 dry powder inhalation once a day for up to 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) | The assessment of safety was based on adverse events, particularly those adverse events known to be associated to treatment with muscarinic antagonists. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Sections. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day | Forced expiratory volume maneuvers recorded using a calibrated spirometer. Trough forced expiratory volume in one second (FEV1) on Days 1 & 28 defined as the mean of the FEV1 values measured at 23 hours 15 minutes and 23 hours 45 minutes post-dose. | 28 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, glycopyrronium bromide, antimuscarinic