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
ashikmrn@gmail.com
Study website
Contact information
Type
Public
Contact name
Mr Mohammad Ashik Imran Khan
ORCID ID
http://orcid.org/0000-0002-3118-5955
Contact details
National Institute of Diseases of the Chest and Hospital
Mohakhali
Dhaka
1000
Bangladesh
+880 (0)2-55067131-40
ashikmrn@gmail.com
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
15/5/2018/4
Study information
Scientific title
Effect of oral azithromycin three times per week on the reduction of asthma exacerbation in patients with persistent asthma
Acronym
Study hypothesis
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
Study design
Single center open label Interventional randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Prevention
Patient information sheet
No participant information sheet available
Condition
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
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Azithromycin
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 study start date
02/03/2018
Overall study end date
01/06/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged ≥ 12 years
2. Persistent asthma patient
Participant type(s)
Patient
Age group
Mixed
Sex
Both
Target number of participants
160
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
01/06/2018
Recruitment end date
01/12/2018
Locations
Countries of recruitment
Bangladesh
Study participating centre
National Institute of Diseases of the Chest and Hospital (NIDCH)
Mohakahali
Dhaka
1212
Bangladesh
Sponsor information
Organisation
National Institute of Diseases of the Chest and Hospital (NIDCH)
Sponsor details
Mohakhali
Dhaka
1212
Bangladesh
+880 2-55067131-40
nidch@hospi.dghs.gov.bd
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
Intention to publish date
01/12/2019
Individual participant data (IPD) sharing plan
The current data sharing plans for this study are unknown and will be available at a later date
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 18/08/2022 | No | No |