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COMPLETEDPHASE3

Masitinib in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels

A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, Phase 3 Study to Compare the Efficacy and the Safety of Masitinib Versus Placebo in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels

NCT03771040•AB Science

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the safety and efficacy of masitinib (6 mg/kg/day) in severe persistent asthma, uncontrolled with high dose of inhaled corticosteroid and with elevated eosinophil levels.

Detailed Description

Masitinib is a selective tyrosine kinase inhibitor. It is known that activation of inflammatory cells, such as mast cells, and fibrous tissue remodeling are associated with c-Kit, Lyn and PDGFR kinase signaling pathways; all key targets of masitinib. This is a multicenter, double-blind, randomized, parallel-group (ascending dose titration of masitinib to 6.0 mg/kg/day and matching placebo), comparative study of oral masitinib in the treatment of patients with severe asthma, uncontrolled with high dose of inhaled corticosteroid and with elevated eosinophil levels. Eligible patients will be treated during at least 48 weeks.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with a physician diagnosis of persistent asthma for at least 12 months based on Global Initiative for Asthma (GINA) 2009 Guidelines whose asthma is partially controlled or uncontrolled on inhaled corticosteroids (ICS) / long-acting beta2-agonists (LABA) combination therapy.
•Patient with elevated eosinophil level related to asthma at baseline: ≥0.15 K/uL or patient with eosinophil level ≥0.15 K/uL related to asthma demonstrated in the year prior to screening
•Non-smoker patient for at least one year and with a prior tobacco consumption \<10 packs/year

Exclusion Criteria

•Female patient who is pregnant or lactating
•Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control
•Chronic obstructive pulmonary disease and/or other lung diseases impairing Pulmonary Function Tests
•Within 12 weeks prior to screening, patient who received oral corticosteroids for any other reason than to treat severe asthma exacerbation (patients needing long term corticosteroids intake to control basal asthma condition)
•Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit
•Patient with active lung disease other than asthma (e.g. chronic bronchitis)

Locations (5)

Centro Respiratorio Quilmes

Buenos Aires, Argentina

Sarawak General Hospital

Kuching, Malaysia

Clínica Universidad de los Andes

Miraflores, Peru

The Philippine Heart Center

Quezon City, Philippines

National institute of phthisiology and pulmonology named after F.G. Yanovsky NAMS of Ukraine

Kiev, Ukraine

Key Dates

Start Date

December 1, 2016

Primary Completion Date

September 1, 2020

Completion Date

September 1, 2020

Last Updated

December 8, 2020

Enrollment

347

ACTUAL participants

Conditions

Asthma

Interventions

Masitinib

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: December 8, 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.

View ClinicalTrials.gov Terms and Conditions

Masitinib in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels

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