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AZISAST Study: AZIthromycin in Severe ASThma Study

NCT00760838 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2014-06-26

Study results available
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Summary

The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain inadequately controlled despite GINA (2006) step 4 or 5 therapy.

Conditions

Interventions

DRUG

Azithromycin 250 mg

Azithromycin 250 mg three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks

DRUG

Placebo

Placebo three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks

Sponsors & Collaborators

  • Agentschap voor Innovatie door Wetenschap en Technologie

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Guy Brusselle, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-02-28
Completion
2011-09-30

Countries

  • Belgium

Study Locations

More Related Trials

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 NCT00760838 on ClinicalTrials.gov