Effect of oral azithromycin three times per week on the reduction of asthma exacerbation in patients with persistent asthma
| ISRCTN | ISRCTN14464685 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14464685 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 15/5/2018/4 |
| Sponsor | National Institute of Diseases of the Chest and Hospital (NIDCH) |
| Funder | Investigator initiated and funded |
- Submission date
- 03/11/2019
- Registration date
- 14/11/2019
- Last edited
- 18/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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
ashikmrn@gmail.com
Contact information
Public
National Institute of Diseases of the Chest and Hospital
Mohakhali
Dhaka
1000
Bangladesh
 ORCID ID |
0000-0002-3118-5955 |
|---|---|
| Phone | +880 (0)2-55067131-40 |
| ashikmrn@gmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single center open label Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Effect of oral azithromycin three times per week on the reduction of asthma exacerbation in patients with persistent asthma |
| Study objectives | Oral azithromycin 500 mg, three times weekly on alternate days as an add on therapy in patients with persistent asthma lead to reduced exacerbations |
| Ethics approval(s) | Approved 15/05/2018, National Institute of Diseases of the Chest and Hospital (NIDCH) Thesis committee (Mohakhali, Dhaka, 1000, Bangladesh; +880 2-55067131-40; nidch@hospi.dghs.gov.bd), ref: n/a |
| Health condition(s) or problem(s) studied | Persistent asthma |
| Intervention | 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. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Azithromycin |
| Primary outcome measure(s) |
Number of asthma exacerbation episodes, measured by self-report at baseline and 24 weeks |
| Key secondary outcome measure(s) |
At 24 weeks: |
| Completion date | 01/06/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 160 |
| Key inclusion criteria | 1. Aged ≥ 12 years 2. Persistent asthma patient |
| Key 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 |
| Date of first enrolment | 01/06/2018 |
| Date of final enrolment | 01/12/2018 |
Locations
Countries of recruitment
- Bangladesh
Study participating centre
Dhaka
1212
Bangladesh
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 18/08/2022 | No | No |
Additional files
- 37387 Protocol.pdf
- Protocol file
Editorial Notes
18/08/2022: Uploaded protocol (not peer-reviewed) as an additional file.
15/11/2019: Internal review.
11/11/2019: Trial’s existence confirmed by National Institute of Diseases of the Chest and Hospital (NIDCH)
