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A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients

A Double-blind, Placebo-controlled, Study Examining the Effect of Orally Administered QAW039 (450 mg QD) on FEV1 and ACQ in Non-atopic, Asthmatic Patients With a Baseline, Pre-bronchodilator FEV1 of 40-80% Predicted, Inadequately Controlled With Low Dose ICS Therapy

NCT01836471•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The purpose of the study was to assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose Inhaled Corticosteroid (ICS) as background therapy.

Detailed Description

This was a multi-centre, randomised, placebo-controlled, double blind, 3-arm study designed to compare the efficacy and safety of a once daily dose of QAW039 with placebo in non-atopic and atopic asthmatics both inadequately controlled despite receiving a low dose ICS background therapy, over a 12 week treatment period. Efficacy and safety of a once daily dose of QAW039 was also compared with an increased dose of ICS in atopic asthmatics taking low dose ICS as background therapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Written informed consent must be obtained before any assessment is performed
•Patients with a diagnosis of persistent asthma (according to Global Initiative for Asthma 2011) for a period of at least 6 months prior to screening
•Patients with a pre-bronchodilator Forced Expiratory Volume In One Second (FEV1) value of 40% to 80% of individual predicted value at screening and prior to treatment
•An Asthma Control Questionnaire score ≥ 1.5 prior to treatment
•Demonstration of reversible airway obstruction

Exclusion Criteria

•Pregnant or nursing (lactating) women
•Acute illness other than asthma at the start of the study
•Patients with clinically significant laboratory abnormalities at screening
•Patients with clinically significant condition which may compromise subject safety or interfere with study evaluation
•Use of other investigational drugs at the time of enrollment

Locations (76)

Novartis Investigative Site

Encinitas, California, United States

Novartis Investigative Site

Huntington Beach, California, United States

Novartis Investigative Site

Los Angeles, California, United States

Novartis Investigative Site

Los Angeles, California, United States

Novartis Investigative Site

Mission Viejo, California, United States

Novartis Investigative Site

Orange, California, United States

Novartis Investigative Site

Palmdale, California, United States

Novartis Investigative Site

Riverside, California, United States

Novartis Investigative Site

Rolling Hills Estates, California, United States

Novartis Investigative Site

San Diego, California, United States

Key Dates

Start Date

May 1, 2013

Primary Completion Date

February 1, 2016

Completion Date

February 1, 2016

Last Updated

March 20, 2017

Enrollment

345

ACTUAL participants

Conditions

Asthma

Interventions

QAW039

DRUG

Placebo QAW039

DRUG

Fluticasone 250 mcg

DRUG

Fluticasone 100 mcg

DRUG

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

View study

RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

View study

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 20, 2017Data 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.

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A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients

Inclusion Criteria

Exclusion Criteria

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma