Plain English Summary
Background and study aims
Asthma is a common lung condition that causes occasional breathing difficulties. It affects people of all ages and often starts in childhood, although it can also develop for the first time in adults. This study evaluated the effect of oral azithromycin on reduction of asthma exacerbations in adults with persistent asthma.
Who can participate?
Patients aged 12 years or older, with persistent asthma
What does the study involve?
Participants were either treated as usual or treated as usual with the addition of azithromycin, for 24-weeks.
What are the possible benefits and risks of participating?
Benefits: Reduced number of exacerbations in the participant.
Risks: Emergence of resistant organisms, adverse effects of Azithromycin may be experienced by the patients
Where is the study run from?
National Institute of Diseases of the Chest and Hospital (NIDCH), Bangladesh
When is the study starting and how long is it expected to run for?
June 2018 to June 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Mohammad Ashik Imran Khan
Effect of oral azithromycin three times per week on the reduction of asthma exacerbation in patients with persistent asthma
Oral azithromycin 500 mg, three times weekly on alternate days as an add on therapy in patients with persistent asthma lead to reduced exacerbations
Approved 15/05/2018, National Institute of Diseases of the Chest and Hospital (NIDCH) Thesis committee (Mohakhali, Dhaka, 1000, Bangladesh; +880 2-55067131-40; email@example.com), ref: n/a
Single center open label Interventional randomized controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
No participant information sheet available
Eligible patients were allocated randomly into group A and in group B in equal number using block randomisation. Group A was treated with azithromycin 500 mg three times every alternate day for 24 weeks and group B was treated with conventional therapy for asthma. The patients of either group were evaluated at baseline, during and at the end of 24 weeks. Records of exacerbation (moderate vs severe), number of exacerbations, symptomatic improvement and adverse events were monitored during the study period.
Primary outcome measure
Number of asthma exacerbation episodes, measured by self-report at baseline and 24 weeks
Secondary outcome measures
At 24 weeks:
1. Total number of types of asthma exacerbation according to severity (moderate vs severe)
2. Adverse effects occurring in patients treated with azithromycin
3. Changes in self-reported asthma symptoms
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Aged ≥ 12 years
2. Persistent asthma patient
Target number of participants
Participant exclusion criteria
1. Substantial parenchymal lung disease, such as emphysema
2. Current and ex-smokers
3. Patients with hearing impairment
4. Abnormally prolonged QTc interval
5. Asthma with bronchiectasis
6. Hypersensitivity to azithromycin
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
National Institute of Diseases of the Chest and Hospital (NIDCH)
Investigator initiated and funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)