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

This study has been completed.
Sponsor:
Information provided by:
AB Science
ClinicalTrials.gov Identifier:
NCT00842270
First received: February 11, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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 Intervention Phase
Asthma
Drug: AB1010
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AB Science:

Primary Outcome Measures:
  • decrease in oral corticosteroid therapy (weaning extent) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • asthma control improvement [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • asthma exacerbation rate [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: January 2006
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided by AB Science

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alain Moussy, AB Science
ClinicalTrials.gov Identifier: NCT00842270     History of Changes
Other Study ID Numbers: AB04026
Study First Received: February 11, 2009
Last Updated: February 11, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on August 18, 2014