Condition category
Respiratory
Date applied
03/11/2019
Date assigned
14/11/2019
Last edited
15/11/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Public

Primary contact

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 number

Nil known

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

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

Trial setting

Hospitals

Trial 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

Phase

Not Applicable

Drug names

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 trial start date

02/03/2018

Overall trial end date

01/06/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged ≥ 12 years
2. Persistent asthma patient

Participant type

Patient

Age group

Mixed

Gender

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

Trial 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

http://www.nidch.gov.bd

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.

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

01/12/2019

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

15/11/2019: Internal review. 11/11/2019: Trial’s existence confirmed by National Institute of Diseases of the Chest and Hospital (NIDCH)