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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

AB1010

placebo

About this trial

This is an interventional treatment trial for Asthma focused on measuring severe asthma, corticosteroids dependent, asthma exacerbation, weaning, tyrosine kinase inhibitor, severe persistent corticosteroid dependent asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Arm Description

4,5 mg/kg/day

6 mg/kg/day

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

AB1010 3 mg/kg/day

Outcomes

Primary Outcome Measures

decrease in oral corticosteroid therapy (weaning extent)

Secondary Outcome Measures

asthma control improvement

asthma exacerbation rate

Full Information

NCT ID

NCT00842270

First Posted

February 11, 2009

Last Updated

December 8, 2018

Sponsor

AB Science

1. Study Identification

Unique Protocol Identification Number

NCT00842270

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

July 2007 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AB Science

4. Oversight

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

4,5 mg/kg/day

Arm Title

Arm Type

Experimental

Arm Description

6 mg/kg/day

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Arm Type

Experimental

Arm Description

AB1010 3 mg/kg/day

Intervention Type

Drug

Intervention Name(s)

AB1010

Other Intervention Name(s)

masitinib

Intervention Description

3 mg/kg/day

Intervention Type

Drug

Intervention Name(s)

AB1010

Other Intervention Name(s)

masitinib

Intervention Description

4,5 mg/kg/day

Intervention Type

Drug

Intervention Name(s)

AB1010

Other Intervention Name(s)

masitinib

Intervention Description

6 mg/kg/day

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

matching placebo to AB1010 dosages

Primary Outcome Measure Information:

Title

decrease in oral corticosteroid therapy (weaning extent)

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

asthma control improvement

Time Frame

16 weeks

Title

asthma exacerbation rate

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Citations:

PubMed Identifier

22487554

Citation

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.

Results Reference

background

PubMed Identifier

19614621

Citation

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.

Results Reference

result

Links:

URL

https://www.karger.com/Article/Abstract/335122

Description

Publication of preclinical study results

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

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