Status:
COMPLETED
AZISAST Study: AZIthromycin in Severe ASThma Study
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Agentschap voor Innovatie door Wetenschap en Technologie
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 controll...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00760838
Start Date
March 1 2009
End Date
September 1 2011
Last Update
June 26 2014
Active Locations (7)
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1
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, Belgium, 9300
2
ZNA Middelheim
Antwerp, Belgium, 2020
3
AZ Sint-Jan Brugge
Bruges, Belgium, 8000
4
Ghent University Hospital
Ghent, Belgium, 9000