Phase 4
N=109
AZISAST Study: AZIthromycin in Severe ASThma Study
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00760838 ↗Enrolled (actual)
109
Serious AEs
10.1%
Results posted
Jun 2014
Primary outcome: Primary: Proportion of Participants With Severe Asthma Exacerbations — 0.52; 0.55 proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Azithromycin 250 mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital, Ghent
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Severe Asthma Exacerbations |
0.52; 0.55 | — |
| SECONDARY Proportion of Participants Using Rescue Medication From Baseline to Week 26 |
0.24; 0.08 | — |
| SECONDARY Peakflow Measurements |
-5.77; -1.81; -4.65; -0.81 | — |
| SECONDARY Change in Forced Expiratory Volume in 1 Second |
-0.90; -0.02; -0.66; 8.84 | — |
| SECONDARY Change in Total Score on Asthma Control Questionnaire (ACQ) |
-0.12; -0.24 | — |
| SECONDARY Change in Total Score on the Asthma-related Quality of Life (AQLQ) |
0.20; 0.32 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00760838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.