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A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma

A Randomized Double-blind Multiple-dose Placebo-controlled Trial to Establish the Efficacy of QBX258 (Combination of VAK694 and QAX576) in Asthma That is Inadequately Controlled With Inhaled Corticosteroids and Long Acting Beta Agonists

NCT01479595•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study is designed to investigate the efficacy and safety of QBX258 in subjects with moderate to severe asthma.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with atopic asthma \>1 year duration diagnosed according to the GINA guidelines.
•Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 39 kg/m2.
•Asthma which is not adequately controlled on current treatment, as demonstrated by an Asthma Control Questionnaire (ACQ) score of \> 1.5.
•FEV1 40 to 90% of predicted.

Exclusion Criteria

•Diagnosed with COPD as defined by the GOLD guidelines
•Subjects who have had a respiratory tract infection within 4 weeks prior to screening.
•Women of child-bearing potential must use highly effective methods of contraception during dosing and for at least 18 weeks after last study drug administration

Locations (20)

Novartis Investigative Site

Anaheim, California, United States

Novartis Investigative Site

Riverside, California, United States

Novartis Investigative Site

Rolling Hills Estates, California, United States

Novartis Investigative Site

San Marino, California, United States

Novartis Investigative Site

Denver, Colorado, United States

Novartis Investigative Site

Denver, Colorado, United States

Novartis Investigative Site

Aventura, Florida, United States

Novartis Investigative Site

Boston, Massachusetts, United States

Novartis Investigative Site

Minneapolis, Minnesota, United States

Novartis Investigative Site

St Louis, Missouri, United States

Key Dates

Start Date

February 1, 2012

Primary Completion Date

February 1, 2015

Completion Date

February 1, 2015

Last Updated

August 1, 2016

Enrollment

ACTUAL participants

Conditions

Asthma

Interventions

QBX258

DRUG

Placebo

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: August 1, 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.

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A Study to Establish the Efficacy of QBX258 in Patients With Moderate to Severe Asthma

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)

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