Efficacy of Oral AB1010 in Adult Patients With Severe Persistent Corticosteroid Dependent Asthma

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. Identifier: NCT00842270
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : February 12, 2009
Information provided by:
AB Science

Brief Summary:

The aim of the study is to evaluate, comparatively to a placebo, the activity of oral AB1010, administered at three dose levels during 4 months to patients with severe persistent corticosteroid dependent asthma, assessed on :

  • the decrease in corticosteroid therapy
  • the asthma control improvement (symptomatic scores, rescue medication intake, respiratory function)
  • the pharmacokinetic profile of AB1010
  • clinical and biological safety parameters

Condition or disease Intervention/treatment Phase
Asthma Drug: AB1010 Drug: placebo Phase 2

Detailed Description:

This is a double-blind, placebo-controlled, randomized, parallel-groups, multicenter study of daily oral AB1010 at doses 3, 4.5 and 6 mg/kg/day.

The study treatment is administered for 16 weeks:

  • the first 4 weeks are a run-in period during which corticosteroids remain stable;
  • during the following 8 weeks, corticosteroids are decreased every week until weaning or an exacerbation occurs;
  • the last 4 weeks are a stabilization period. Patients have to perform a visit every 2 weeks during run-in, then every week for the following 3 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Efficacy of Oral AB1010 in Adult Patients With Severe Persistent Corticosteroid Dependent Asthma
Study Start Date : January 2006
Actual Primary Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arm Intervention/treatment
Experimental: 2
4,5 mg/kg/day
Drug: AB1010
4,5 mg/kg/day
Other Name: masitinib

Experimental: 3
6 mg/kg/day
Drug: AB1010
6 mg/kg/day
Other Name: masitinib

Placebo Comparator: 4
matching placebo for AB1010 3, 4,5 and 6 mg/kg/day
Drug: placebo
matching placebo to AB1010 dosages

Experimental: 1
AB1010 3 mg/kg/day
Drug: AB1010
3 mg/kg/day
Other Name: masitinib

Primary Outcome Measures :
  1. decrease in oral corticosteroid therapy (weaning extent) [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. asthma control improvement [ Time Frame: 16 weeks ]
  2. asthma exacerbation rate [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Known severe persistent corticosteroid dependent asthma (WHO/NHLBI workshop definition).
  • Disease duration > 1 year.
  • Stable disease with no exacerbation episode for at least one month before inclusion.
  • Daily treated with 10 to 50 mg of equivalent prednisolone, with stable dosage since at least 3 months.
  • Known reversibility of bronchial obstruction, defined as an enhancement of FEV1 ≥ 12%, 10 minutes after salbutamol administration, or 14 days after systemic treatment with 1 mg/kg/day of equivalent prednisolone.

Exclusion Criteria:

  • Asthmatic patients still exposed to allergens or to triggering factors influencing asthma control.
  • History of infection requiring hospitalization or treatment with antibiotics within 2 weeks of screening.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alain Moussy, AB Science Identifier: NCT00842270     History of Changes
Other Study ID Numbers: AB04026
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: February 12, 2009
Last Verified: February 2009

Keywords provided by AB Science:
severe asthma
corticosteroids dependent
asthma exacerbation
tyrosine kinase inhibitor
severe persistent corticosteroid dependent asthma

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases