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
Secondary identifying numbers	15/5/2018/4

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Mr Mohammad Ashik Imran Khan
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
Email	ashikmrn@gmail.com

Study information

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
Participant information sheet	No participant information sheet available
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
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
Completion date	01/06/2019

Eligibility

Participant type(s)	Patient
Age group	Mixed
Sex	Both
Target number of participants	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

National Institute of Diseases of the Chest and Hospital (NIDCH)

Mohakahali
Dhaka
1212
Bangladesh

Sponsor information

National Institute of Diseases of the Chest and Hospital (NIDCH)
Hospital/treatment centre

Mohakhali
Dhaka
1212
Bangladesh

Phone	+880 2-55067131-40
Email	nidch@hospi.dghs.gov.bd
Website	http://www.nidch.gov.bd

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	01/12/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
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?
Protocol file			18/08/2022	No	No

Additional files

37387 Protocol.pdf

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)