The AZIthromycin in Severe ASThma (AZISAST) Study: a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating 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

University Hospital, Ghent7 sites in 1 country109 target enrollmentMarch 2009

ConditionsAsthma

InterventionsAzithromycin 250 mg Placebo

DrugsAzithromycin 250 mg Placebo

Overview

Phase: Phase 4
Intervention: Azithromycin 250 mg
Conditions: Asthma
Sponsor: University Hospital, Ghent
Enrollment: 109
Locations: 7
Primary Endpoint: Proportion of Participants With Severe Asthma Exacerbations
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

September 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Ghent

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•patients who have given written informed consent
•males or females of any race
•18-75 years of age
•with the diagnosis of persistent asthma ≥ 1 year duration at screening and a history consistent with GINA step 4 or 5 clinical features
•receiving high dose ICS plus inhaled LABA for at least 6 months prior to screening
•patients who have suffered multiple (i.e. at least two) independent documented severe asthma exacerbations within the previous 12 months
•patients must be never-smokers or ex-smokers with a smoking history of ≤ 10 pack-years.

Exclusion Criteria

•females who are pregnant or who are breastfeeding
•patients with severe bronchiectasis
•patients with active tuberculosis or non-tuberculous mycobacterial infections (NTM)
•patients with significant underlying medical conditions (e.g. infection, hematological disease, malignancy, neurologic, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinologic or gastrointestinal disease) within the previous 3 months
•who are unable to perform spirometry or complete a patient diary or complete questionnaires
•patients with known hypersensitivity to azithromycin or other macrolide antibiotics
•patients who's heart rate corrected QT interval is prolonged
•patients who have - in the judgement of the investigator - a clinically relevant laboratory abnormality
•patients currently treated with macrolide antibiotics or recent macrolide treatment (in the past twelve weeks)
•anti-IgE treatment

Arms & Interventions

Azithromycin

Azithromycin 250 mg 1x/day during 5 days 3x/week afterwards

Intervention: Azithromycin 250 mg

placebo

Placebo 1x/day during 5 days 3x/week afterwards

Intervention: Placebo

Outcomes

Primary Outcomes

Proportion of Participants With Severe Asthma Exacerbations

Time Frame: from baseline to week 26

Severe asthma exacerbations are defined as severe asthma episodes for which a treatment with antibiotics or cortisone is administered for a minimum of 3 days.

Secondary Outcomes

Proportion of Participants Using Rescue Medication From Baseline to Week 26(from baseline to week 26)
Change in Forced Expiratory Volume in 1 Second(from baseline to week 26)
Change in Total Score on Asthma Control Questionnaire (ACQ)(from baseline to week 26)
Change in Total Score on the Asthma-related Quality of Life (AQLQ)(from baseline to week 26)
Peakflow Measurements(from baseline to week 26)