Overview

AZISAST Study: AZIthromycin in Severe ASThma Study

Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Ghent
Collaborator:
Agentschap voor Innovatie door Wetenschap en Technologie
Treatments:
Azithromycin
Criteria
Inclusion Criteria:

1. patients who have given written informed consent

2. males or females of any race

3. 18-75 years of age

4. with the diagnosis of persistent asthma ≥ 1 year duration at screening and a history
consistent with GINA step 4 or 5 clinical features

5. receiving high dose ICS plus inhaled LABA for at least 6 months prior to screening

6. patients who have suffered multiple (i.e. at least two) independent documented severe
asthma exacerbations within the previous 12 months

7. patients must be never-smokers or ex-smokers with a smoking history of ≤ 10
pack-years.

Exclusion Criteria:

1. females who are pregnant or who are breastfeeding

2. patients with severe bronchiectasis

3. patients with active tuberculosis or non-tuberculous mycobacterial infections (NTM)

4. 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

5. who are unable to perform spirometry or complete a patient diary or complete
questionnaires

6. patients with known hypersensitivity to azithromycin or other macrolide antibiotics

7. patients who's heart rate corrected QT interval is prolonged

8. patients who have - in the judgement of the investigator - a clinically relevant
laboratory abnormality

9. patients currently treated with macrolide antibiotics or recent macrolide treatment
(in the past twelve weeks)

10. anti-IgE treatment