Masitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids

Asthma Clinical Trial

Official title:

A Prospective, Multicenter, Randomised, Double-blind, Placebo-controlled, 2-parallel Groups, Phase 3 Study 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449162
• Other study ID #: AB07015
• Status: Completed
• Phase: Phase 3
• Start date: January 2011
• Est. completion date: November 2019

Study information

• Verified date: February 2021
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. The objective of this study is to compare the efficacy and safety of masitinib at 6 mg/kg/day versus matched placebo in severe persistent asthma patients that is uncontrolled with oral corticosteroids. The primary outcome measure will be severe asthma exacerbation rate over duration of the treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Main inclusion criteria:

1. 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

2. Patient treated with oral corticosteroids during at least one period of 21 days, from 1 year prior to screening to 3 months before screening

3. Patient with no significant change in the regular asthma medication, no severe asthma exacerbation for at least 4 weeks prior to screening visit

4. Non-smoker patient for at least 1 year and with a prior tobacco consumption < 10 packs/year

Main exclusion criteria:

1. Patient with active lung disease other than asthma (e.g. chronic bronchitis)

2. Female patient who is pregnant or lactating

3. Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control

4. Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Masitinib
6 mg/kg/day
• Placebo

Locations

Country	Name	City	State
Bulgaria	Dr. Georgi Stranski University Hospital	Pleven
Czechia	Hospital Polyclinic Melnik	Melník
France	Hospital La Cavale Blanche	Brest
France	l'Hopital Albert Calmette	Lille
France	l'Hopital de la Croix Rousse	Lyon
Hungary	University of Debrecen Medical and Health Science Center	Debrecen
India	King George Hospital	Hyderabad
Spain	Hospital Universitario Doctor Peset	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

Countries where clinical trial is conducted

Bulgaria,  Czechia,  France,  Hungary,  India,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Asthma exacerbation rate	The number of 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	ACQ Score	Asthma Control Questionnaire (ACQ) Score	36 weeks