Status:
COMPLETED
Efficacy of Oral AB1010 in Adult Patients With Severe Persistent Corticosteroid Dependent Asthma
Lead Sponsor:
AB Science
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 depend...
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: * t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00842270
Start Date
January 1 2006
Last Update
December 11 2018
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.