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Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Randomized, Double-blind, Placebo Controlled, Multicentre Study to Determine the Effect of QVA149 on Lung Function in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00570778•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will evaluate the safety and efficacy of QVA149 in patients with moderate to severe COPD.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
•2. Patients with moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines 2006.
•3. Patients who have smoking history of at least 10 pack years.
•4. Patients with a post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) ≥30% and \< 80% of the predicted normal and post-bronchodilator FEV1/Forced Vital Capacity (FVC) \<0.70.

Exclusion Criteria

•1. Pregnant or nursing women, or women of child-bearing potential, regardless of whether or not sexually active if they are not using acceptable methods of contraception.
•2. Patients requiring long term oxygen therapy (\> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency department for a COPD exacerbation or as result of their airways disease in the 6 weeks prior to screening.
•3. Patients who have had a respiratory tract infection within 6 weeks prior to screening.
•4. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.
•5. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count \> 400/mm3.
•6. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
•7. Patients with uncontrolled Type I and Type II diabetes.
•8. History of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years.
•9. Patients who are contraindicated for or who have shown an untoward reaction to inhaled anticholinergic agents.
•10. Patients with a history of long QT syndrome or whose QTc interval (Fridericia method) measured at screening is prolonged (\>450 ms for males or \>470 ms for females).
+1 more criteria

Locations (22)

Novartis Investigator Site

St Louis, Missouri, United States

Novartis Investigator Site

Charlotte, North Carolina, United States

Novartis Investigator site

Raleigh, North Carolina, United States

Novartis Investigator Site

Antwerp, Belgium

Novartis Investigator Site

Ghent, Belgium

Novartis Investigator Site

Jambes, Belgium

Novartis Investigator Site

Sankt Vith, Belgium

Novartis Investigator Site

Moncton, Canada

Novartis Investigator Site

Montreal, Canada

Novartis Investigator site

Toronto, Canada

Key Dates

Start Date

December 1, 2007

Primary Completion Date

September 1, 2008

Completion Date

September 1, 2008

Last Updated

July 26, 2018

Enrollment

154

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

indacaterol/glycopyrrolate

DRUG

indacaterol

DRUG

placebo

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

View study

RECRUITINGNA

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

NCT07382258

Chronic Obstructive Pulmonary Disease (COPD)

View study

RECRUITINGNA

Mindful-Breath for People With COPD

NCT07195838

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 26, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy and Safety of QVA149 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

Mindful-Breath for People With COPD

The HELlenic Thoracic Society Initiative for CΟPD and CVD

Magnetic Stimulation of Diaphragm in Chronic Obstructive Pulmonary Disease

COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A