NCT01449162

Brief Summary

The study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P50-P75 for phase_3 asthma

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_3 asthma

Geographic Reach
6 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2011

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

8.8 years

First QC Date

October 6, 2011

Last Update Submit

February 9, 2021

Conditions

Asthma

Keywords

severe persistent asthmatyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (1)

  • Severe asthma exacerbation rate

    The number of severe asthma exacerbations over time frame of outcome measure

    Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months

Secondary Outcomes (2)

  • Asthma exacerbation rate

    Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months

  • ACQ Score

    36 weeks

Study Arms (2)

Masitinib as add-on to oral corticosteroids

EXPERIMENTAL

Participants receive masitinib (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids

Drug: Masitinib

Placebo as add-on to oral corticosteroids

PLACEBO COMPARATOR

Participants receive placebo (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids

Drug: Placebo

Interventions

MasitinibDRUG

6 mg/kg/day

Also known as: AB1010
Masitinib as add-on to oral corticosteroids
PlaceboDRUG
Also known as: Placebo Oral Tablet
Placebo as add-on to oral corticosteroids

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with severe asthma and already treated with oral corticosteroids at a minimal daily dose of 7.5 mg prednisone or equivalent for at least 3 months prior to screening visit
  • Patient treated with oral corticosteroids during at least one period of 21 days, from 1 year prior to screening to 3 months before screening
  • Patient with no significant change in the regular asthma medication, no severe asthma exacerbation for at least 4 weeks prior to screening visit
  • Non-smoker patient for at least 1 year and with a prior tobacco consumption \< 10 packs/year

You may not qualify if:

  • Patient with active lung disease other than asthma (e.g. chronic bronchitis)
  • Female patient who is pregnant or lactating
  • Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control
  • Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Dr. Georgi Stranski University Hospital

Pleven, 5800, Bulgaria

Location

Hospital Polyclinic Melnik

Mělník, Czechia

Location

Hospital La Cavale Blanche

Brest, 29609, France

Location

l'Hopital Albert Calmette

Lille, France

Location

l'Hopital de la Croix Rousse

Lyon, 69317, France

Location

University of Debrecen Medical and Health Science Center

Debrecen, 4032, Hungary

Location

King George Hospital

Hyderabad, 500068, India

Location

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

Location

MeSH Terms

Conditions

Asthma

Interventions

masitinib

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Lavinia Davidescu, MD, PhD

    University of Medicine and Pharmacy Oradea, Oradea, Romania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2011

First Posted

October 10, 2011

Study Start

January 1, 2011

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

February 10, 2021

Record last verified: 2021-02

Locations

HU(1)ES(1)CZ(1)FR(3)IN(1)BU(1)