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COMPLETEDPHASE2

Efficacy, Safety, and Pharmacokinetics of QAW039

A Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Pharmacokinetics of QAW039 in Steroid-free Patients With Mild to Moderate Persistent Asthma

NCT01253603•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with a medical history of mild to moderate persistent allergic asthma.
•Patients must weigh at least 45 kg to participate in the study, and must have abody mass index (BMI) of \>17 kg/m2.
•Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception

Exclusion Criteria

•Women of child-bearing potential.
•Smokers defined as history of smoking in the previous 6 months or a smoking history of more than 10 pack years, a pack year being defined as smoking the equivalent of 20 cigarettes - a pack - every day for the period of 1 year
•Patients with severe persistent asthma

Locations (26)

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

San Diego, California, United States

Novartis Investigative Site

San Diego, California, United States

Novartis Investigative Site

San Jose, California, United States

Novartis Investigative Site

Stockton, California, United States

Novartis Investigative Site

Stockbridge, Georgia, United States

Key Dates

Start Date

November 1, 2010

Primary Completion Date

September 1, 2011

Completion Date

September 1, 2011

Last Updated

December 19, 2020

Enrollment

170

ACTUAL participants

Conditions

Persistent Asthma

Interventions

QAW039 capsules once daily for 28 days

DRUG

Placebo to QAW039 capsules once daily for 28 days

DRUG

Fluticasone propionate inhaler twice daily for 28 days

DRUG

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Persistent AsthmaAsthma in Children+1 more

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COMPLETEDPHASE2

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Moderate to Severe Persistent Asthma

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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: December 19, 2020Data 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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Efficacy, Safety, and Pharmacokinetics of QAW039

Inclusion Criteria

Exclusion Criteria

Asthma Research in Children and Adolescents

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