UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043310
Receipt number R000049451
Scientific Title The efficacy of low-dose macrolides for severe asthma in clinical practice
Date of disclosure of the study information 2021/02/12
Last modified on 2024/02/15 12:20:04

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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 or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



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

https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000049451

Publication of results

Unpublished


Result

URL related to results and publications

https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000049451

Number of participants that the trial has enrolled

385

Results

Of the 371 patients who met inclusion criteria, 23 were on macrolides and 348 were not. Patients on macrolides had higher GINA Steps and more sinusitis complications than those on macrolide days.
In a sample of 14 patients who had been on macrolides for at least 12 months, the median number of annual exacerbations dropped from 1 to 0 when comparing the number of exacerbations in the year before and after macrolide initiation (p = 0.042).

Results date posted

2024 Year 02 Month 15 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients with severe asthma (GINA step 4/5) who had been continuously attending the Department of Respiratory Medicine, National Center for Global Health and Medicine for one year from March 1, 2018 to February 28, 2019.
*Excludes cases in which macrolides were started or discontinued during the observation period.

Participant flow

Patients with severe asthma (GINA step 4/5) who had been continuously attending the Department of Respiratory Medicine, National Center for Global Health and Medicine for one year from March 1, 2018 to February 28, 2019.
*Excludes cases in which macrolides were started or discontinued during the observation period.

Adverse events

Nothing particular.

Outcome measures

The clinical characteristics of patients treated with macrorides and the effect of long-term macrolide administration on asthma exacerbations

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

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

2024 Year 02 Month 15 Day



Link to view the page

Value
https://center6.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