A Multi-center, Randomized, Double-blind, 52-week Study to Assess the Safety of NVA237 Compared to QAB149 in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Have Moderate to Severe Airflow Limitation
NVA237
+ Long-acting beta 2-agonist (LABA)
+ Placebo
Chronic Disease+5
+ Lung Diseases
+ Lung Diseases, Obstructive
Treatment Study
Summary
Study start date: October 1, 2012
Actual date on which the first participant was enrolled.The purpose of the study is to provide long term safety data of NVA237. This study will assess the safety and tolerability of a single dose strength of NVA237.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.511 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Male or female patients with COPD according to GOLD 2011 who have signed informed consent. Patients with airflow limitation of 30-80% post-bronchodilator FEV1 at run-in. Current or ex-smokers with a smoking history of at least 10 pack years Patients with a mMRC score of at least 2 at run-in. Exclusion Criteria: Patients contraindicated for muscarinic antagonist agents and beta-2 agonists Patients with a history of malignancy of any organ system, treated or untreated, within the last five years Patients with narrow-angle glaucoma, BPH or bladder-neck obstruction or moderate-severe renal impairment or urinary retention Patients who had a COPD exacerbation within 6 weeks prior to screening. Patients requiring long term oxygen therapy prescribed for more than 12 hr per day. Patients with a history of asthma. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to 40 years of age. Patients with a blood eosinophil count of greater than 600 mm/3 during run-in Patients with concomitant pulmonary disease Patients with a history of certain cardiovascular co-morbid conditions Patients with a diagnosis of alpha-1 anti-trypsin deficiency Patients with active pulmonary tuberculosis Patients in the active phase of a pulmonary rehabilitation programme Other protocol-defined inclusion / exclusion criteria may apply
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 61 locations
Novartis Investigative Site
Gulf Shores, United StatesOpen Novartis Investigative Site in Google MapsNovartis Investigative Site
Mobile, United StatesNovartis Investigative Site
Tucson, United StatesNovartis Investigative Site
Riverside, United States