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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842270
• Other study ID #: AB04026
• Status: Completed
• Phase: Phase 2
• Start date: January 2006

Study information

• Verified date: December 2018
• Source: AB Science
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• AB1010
3 mg/kg/day
• AB1010
4,5 mg/kg/day
• AB1010
6 mg/kg/day
• placebo
matching placebo to AB1010 dosages

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AB Science

References & Publications (2)

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, improve — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease in oral corticosteroid therapy (weaning extent)		16 weeks
Secondary	asthma control improvement		16 weeks
Secondary	asthma exacerbation rate		16 weeks

External Links

•   Publication of clinical study results
•   Publication of preclinical study results