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

NCT ID: NCT00842270

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Asthma

Keywords

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severe asthma corticosteroids dependent asthma exacerbation weaning tyrosine kinase inhibitor severe persistent corticosteroid dependent asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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2

4,5 mg/kg/day

Group Type EXPERIMENTAL

AB1010

Intervention Type DRUG

4,5 mg/kg/day

3

6 mg/kg/day

Group Type EXPERIMENTAL

AB1010

Intervention Type DRUG

6 mg/kg/day

4

matching placebo for AB1010 3, 4,5 and 6 mg/kg/day

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

matching placebo to AB1010 dosages

1

AB1010 3 mg/kg/day

Group Type EXPERIMENTAL

AB1010

Intervention Type DRUG

3 mg/kg/day

Interventions

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AB1010

3 mg/kg/day

Intervention Type DRUG

AB1010

4,5 mg/kg/day

Intervention Type DRUG

AB1010

6 mg/kg/day

Intervention Type DRUG

placebo

matching placebo to AB1010 dosages

Intervention Type DRUG

Other Intervention Names

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masitinib masitinib masitinib

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AB Science

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Lee-Fowler TM, Guntur V, Dodam J, Cohn LA, DeClue AE, Reinero CR. The tyrosine kinase inhibitor masitinib blunts airway inflammation and improves associated lung mechanics in a feline model of chronic allergic asthma. Int Arch Allergy Immunol. 2012;158(4):369-74. doi: 10.1159/000335122. Epub 2012 Apr 4.

Reference Type BACKGROUND
PMID: 22487554 (View on PubMed)

Humbert M, de Blay F, Garcia G, Prud'homme A, Leroyer C, Magnan A, Tunon-de-Lara JM, Pison C, Aubier M, Charpin D, Vachier I, Purohit A, Gineste P, Bader T, Moussy A, Hermine O, Chanez P. Masitinib, a c-kit/PDGF receptor tyrosine kinase inhibitor, improves disease control in severe corticosteroid-dependent asthmatics. Allergy. 2009 Aug;64(8):1194-201. doi: 10.1111/j.1398-9995.2009.02122.x.

Reference Type RESULT
PMID: 19614621 (View on PubMed)

Other Identifiers

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AB04026

Identifier Type: -

Identifier Source: org_study_id