UMIN-ICDS Clinical Trial

Public title

Efficacy of long-term, low dose macrolide therapy for asthma: a systematic review and meta-analysis

Acronym

Efficacy of long-term, low dose macrolide therapy for asthma: a systematic review and meta-analysis

Scientific Title

Efficacy of long-term, low dose macrolide therapy for asthma: a systematic review and meta-analysis

Scientific Title:Acronym

Efficacy of long-term, low dose macrolide therapy for asthma: a systematic review and meta-analysis

Region

Japan

Condition

Asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to seek the efficacy of low-dose, long-term macrolide therapy for adult asthma.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Exacerbation requiring hospitalization

Key secondary outcomes

Severe exacerbations (requiring ED visits or systemic steroids, or both), serious adverse events (including mortality), asthma symptoms (symptom scales, Asthma Control Questionnaire, Asthma quality of life (AQLQ) ), rescue medication (puffs/day), respiratory function (morning PEF, evening PEF, FEV1), bronchial hyperresponsiveness (BHR), and minimum oral corticosteroid dose.

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

According to Global Initiative for Asthma 2022, adult asthma outpatients will be included in the study. The literature to be included will be randomized controlled trials. Macrolides will include clarithromycin, troleandomycin, erythromycin, josamycin, azithromycin, and roxithromycin.

Key exclusion criteria

Pediatric patients under 18 years of old

Target sample size

Name of lead principal investigator

1st name	Yosuke
Middle name
Last name	Fukuda

Organization

Showa University School of Medicine

Division name

Department of medicine, Division of Respiratory medicine and Allergology

Zip code

142-8666

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan

TEL

03-3784-8000

Email

y.f.0423@med.showa-u.ac.jp

Name of contact person

1st name	Yosuke
Middle name
Last name	Fukuda

Organization

Showa University, School of Medicine

Division name

Department of Medicine, Division of Respiratory Medicine and Allergology

Zip code

142-8666

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo, Japan

TEL

03-3784-8000

Homepage URL

Email

y.f.0423@med.showa-u.ac.jp

Institute

The Japanese Respiratory Society

Institute

Department

Personal name

Organization

N/A

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Japanese Respiratory Society

Address

8-28-3 Hongo, Bunkyo-ku, Tokyo, Japan

Tel

03-5805-3553

Email

info@jrs.or.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

04

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

03

Month

31

Day

Date of IRB

Anticipated trial start date

2023

Year

04

Month

01

Day

Last follow-up date

2024

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1. A systematic search of the literature will be conducted according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) Statement. We will search the following electrical databases; the Cochrane Library; PubMed. Additionally, we will also search the other resources; the World Health Organization International Clinical Trials Platform Search Portal (ICTRP) and ClinicalTrials.gov.

2. To assess the risk of bias, we will use the Risk of Bias 2 tool for RCTs. Two reviewers will independently screen the full text of each study and decide whether the studies met the inclusion criteria. Any disagreement will be resolved by discussion or consulting the third reviewer.

3. Meta-analysis will be performed using statistical software, such as Review Manager 5.3.5, R, and STATA.

4. Sensitivity analysis and subgroup analysis will be performed as needed based on the results of the adopted literature.

5. SOF tables will be created for the following outcomes.
1. Exacerbation requiring hospitalization
2. Severe exacerbations (requiring ED visits or systemic steroids, or both)
3. Serious adverse events (including mortality)
4. Asthma symptoms (symptom scales, Asthma Control Questionnaire, Asthma quality of life (AQLQ) )
5. Rescue medication (puffs/day)
6. Respiratory function (morning PEF, evening PEF, FEV1)
7. Bronchial hyperresponsiveness (BHR).
8. Minimum oral corticosteroid dose

Registered date

2023

Year

04

Month

12

Day

Last modified on

2023

Year

04

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057827