UMIN-CTR Clinical Trial

Basic information
Public title	The efficacy of low-dose macrolides for severe asthma in clinical practice
Acronym	The efficacy of low-dose macrolides for severe asthma in clinical practice
Scientific Title	The efficacy of low-dose macrolides for severe asthma in clinical practice
Scientific Title:Acronym	The efficacy of low-dose macrolides for severe asthma in clinical practice
Region	Japan

Condition
Condition	asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of macrolides for asthma exacerbation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The number of annual exacerbations before and after the administration of long-term macrolide therapy
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Asthma patients continuously treated from 2018/3/1 to 2020/9/30 in the department of Respiratory Medicine in National Center for Global Health and Medicine. 2) Asthma patients who received treatment equivalent to Global Initiative for Asthma (GINA) Step 4/5. 3) Asthma patients whose asthma exacerbations requiring systemic steroid was retrospectively trackable in their medical records.
Key exclusion criteria	1) Asthma patients who started or discontinued macrolides for their asthma during 2018/3/1-2020/9/30. 2) Other unsuitable conditions
Target sample size	385

Research contact person
Name of lead principal investigator	1st name Motoyasu Middle name Last name Iikura
Organization	National Center for Global Health and Medicine
Division name	Department of Respiratory Medicine
Zip code	1628655
Address	1-21-1, Toyama, Shinjuku-ku, Tokyo, JAPAN
TEL	03-3202-7181
Email	iimotoya@hosp.ncgm.go.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name Nagano
Organization	National Center for Global Health and Medicine
Division name	Department of Respiratory Medicine
Zip code	1628655
Address	1-21-1, Toyama, Shinjuku-ku, Tokyo, JAPAN
TEL	03-3202-7181
Homepage URL
Email	matsunao28@yahoo.co.jp

Sponsor
Institute	National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization	National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Certified Review Board of National Center for Global Health and Medicine
Address	1-21-1, Toyama, Shinjuku-ku, Tokyo, JAPAN
Tel	03-3202-7181
Email	kenkyu-shinsa@hosp.ncgm.go.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 12 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	385
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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2020 Year 11 Month 01 Day
Date of IRB	2021 Year 01 Month 08 Day
Anticipated trial start date	2020 Year 11 Month 01 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Clinical characteristics, treatment, and the number of exacerbations were reviewed in eligible asthma patients.

Management information
Registered date	2021 Year 02 Month 12 Day
Last modified on	2021 Year 02 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049451

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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