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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01449162
Recruitment Status : Completed
First Posted : October 10, 2011
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
AB Science

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Masitinib Drug: Placebo Phase 3

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. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : June 2011
Actual Primary Completion Date : November 2019
Actual Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arm Intervention/treatment
Experimental: Masitinib as add-on to oral corticosteroids
Participants receive masitinib (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids
Drug: Masitinib
6 mg/kg/day
Other Name: AB1010

Placebo Comparator: Placebo as add-on to oral corticosteroids
Participants receive placebo (6 mg/kg/day), given orally twice daily, as add-on to oral corticosteroids
Drug: Placebo
Other Name: Placebo Oral Tablet




Primary Outcome Measures :
  1. Severe asthma exacerbation rate [ Time Frame: Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months ]
    The number of severe asthma exacerbations over time frame of outcome measure


Secondary Outcome Measures :
  1. Asthma exacerbation rate [ Time Frame: Duration of patient treatment exposure, assessed until withdrawal from study, study completion date, or for a maximum of 60 months ]
    The number of asthma exacerbations over time frame of outcome measure

  2. ACQ Score [ Time Frame: 36 weeks ]
    Asthma Control Questionnaire (ACQ) Score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449162


Locations
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Bulgaria
Dr. Georgi Stranski University Hospital
Pleven, Bulgaria, 5800
Czechia
Hospital Polyclinic Melnik
Mělník, Czechia
France
Hospital La Cavale Blanche
Brest, France, 29609
l'Hopital Albert Calmette
Lille, France
l'Hopital de la Croix Rousse
Lyon, France, 69317
Hungary
University of Debrecen Medical and Health Science Center
Debrecen, Hungary, 4032
India
King George Hospital
Hyderabad, India, 500068
Spain
Hospital Universitario Doctor Peset
Valencia, Spain, 46017
Sponsors and Collaborators
AB Science
Investigators
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Principal Investigator: Lavinia Davidescu, MD, PhD University of Medicine and Pharmacy Oradea, Oradea, Romania

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Responsible Party: AB Science
ClinicalTrials.gov Identifier: NCT01449162    
Other Study ID Numbers: AB07015
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020
Keywords provided by AB Science:
severe persistent asthma
tyrosine kinase inhibitor
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases