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)

Novartis1 site in 1 country281 target enrollmentAugust 2007

ConditionsChronic Obstructive Pulmonary Disease (COPD)

InterventionsNVA237 100 µg NVA237 200 µg Placebo

DrugsNVA237 100 µg Placebo NVA237 200 µg

Overview

Phase: Phase 2
Intervention: NVA237 100 µg
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Novartis
Enrollment: 281
Locations: 1
Primary Endpoint: Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

January 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

NVA237 100 µg

Intervention: NVA237 100 µg

NVA237 200 µg

Intervention: NVA237 200 µg

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Time Frame: 28 days

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.