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A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation. | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.

A 12-week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.

NCT01727141•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to severe airflow limitation.

Detailed Description

NOTE: Detailed Description: data not entered

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and female patients that have signed informed consent and are \>/= 40 years of age.
•Patients with stable COPD according to GOLD 2011.
•Patients with a post-bronchodilator FEV1 of \>/= 30% and \< 80% predicted and a post-bronchodilator FEV1/FVC \<0.70.
•Current or ex-smokers who have a smoking history of at least 10 pack years.
•Patients with an mMRC grade 2 or greater.

Exclusion Criteria

•Patients with Type I or uncontrolled Type II diabetes - Patients with a history of long QT syndrome or whose QTc measured at Visit 101 (Fridericia method) is prolonged (\>450 ms for males and females) and confirmed by a central assessor. (These patients should not be re-screened.)
•Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 102. (These patients should not be re-screened.)
•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 who have a respiratory tract infection within 4 weeks prior to screening.
•Patients requiring long term oxygen therapy prescribed for more than 12 hr per day.
•Patients with a history of asthma. 8. Patients with an onset of respiratory symptoms, including COPD diagnosis, prior to age 40 years.
•Patients with a blood eosinophil count of greater than 600 mm/3 during run-in.
•Patients with concomitant pulmonary disease.
+3 more criteria

Locations (143)

Novartis Investigative Site

Birmingham, Alabama, United States

Novartis Investigative Site

Montgomery, Alabama, United States

Novartis Investigative Site

Mesa, Arizona, United States

Novartis Investigative Site

Phoenix, Arizona, United States

Novartis Investigative Site

Fountain Valley, California, United States

Novartis Investigative Site

Fullerton, California, United States

Novartis Investigative Site

Huntington Beach, California, United States

Novartis Investigative Site

Montclair, California, United States

Novartis Investigative Site

Orange, California, United States

Novartis Investigative Site

Orangevale, California, United States

Key Dates

Start Date

November 1, 2012

Primary Completion Date

February 1, 2014

Completion Date

February 1, 2014

Last Updated

March 29, 2016

Enrollment

1,042

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

QVA149

DRUG

QAB149

DRUG

NVA237

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: March 29, 2016Data 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

A 12 Week Treatment, Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol Maleate / Glycopyrronium Bromide in COPD Patients With Moderate to Severe Airflow Limitation.

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