Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

NVA237

+ Long-acting beta 2-agonist (LABA)

+ Placebo

Drug
Who is being recruted

Chronic Disease+5

+ Lung Diseases

+ Lung Diseases, Obstructive

Over 40 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals
Last updated: March 16, 2016
Sourced from a government-validated database.Claim as a partner

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.

NCT01697696
Principal SponsorNovartis Pharmaceuticals
Last updated: March 16, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

511 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Chronic DiseaseLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiratory Tract DiseasesPathological Conditions, Signs and SymptomsDisease AttributesPulmonary Disease, Chronic Obstructive

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
NVA237 dose 1

Group II

Active Comparator
QAB149

Study 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 Maps

Novartis Investigative Site

Mobile, United States

Novartis Investigative Site

Tucson, United States

Novartis Investigative Site

Riverside, United States
Completed61 Study Centers