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

NCT00842270 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-12-11

No results posted yet for this study

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

Conditions

Interventions

DRUG

AB1010

3 mg/kg/day

DRUG

AB1010

4,5 mg/kg/day

DRUG

AB1010

6 mg/kg/day

DRUG

placebo

matching placebo to AB1010 dosages

Sponsors & Collaborators

  • AB Science

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2007-07-31

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00842270 on ClinicalTrials.gov