Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
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)
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).
Status | Completed |
Enrollment | 281 |
Est. completion date | January 2008 |
Est. primary completion date | January 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | Novartis investigative site | Rueil-Malmaison | |
Germany | Novartis investigative site | Nurnberg | |
Netherlands | Novartis investigative site | Arnhem | |
Spain | Novartis investigative site | Barcelona | |
Turkey | Novartis investigative site | Istanbul | |
United States | Novartis investigative site | Charlotte | North Carolina |
United States | Novartis investigative site | Ft Worth | Texas |
United States | Novartis investigative site | Glendale | Arizona |
United States | Novartis investigative site | Houston | Texas |
United States | Novartis investigative site | Miami | Florida |
United States | Novartis investigative site | Miami | Florida |
United States | Novartis investigative site | Newark | Delaware |
United States | Novartis investigative site | Overland Park | Kansas |
United States | Novartis investigative site | Phoenix | Arizona |
United States | Novartis investigative site | Portland | Oregon |
United States | Novartis investigative site | River Forest | Illinois |
United States | Novartis investigative site | Spartanburg | South Carolina |
United States | Novartis investigative site | St. Chares | Missouri |
United States | Novartis investigative site | Tamarac | Florida |
United States | Novartis investigative site | Union | South Carolina |
United States | Novartis investigative site | Wheat Ridge | Colorado |
Lead Sponsor | Collaborator |
---|---|
Novartis |
United States, France, Germany, Netherlands, Spain, Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | 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 | No |
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