UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034263
Receipt number R000039066
Scientific Title Investigation of the merger ratio of Obstructive Sleep Apnea(OSA) in Bronchial Asthma(BA) and search for biomarkers of OSA-associated BA
Date of disclosure of the study information 2018/09/25
Last modified on 2021/03/28 15:22:25

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Basic information

Public title

Investigation of the merger ratio of Obstructive Sleep Apnea(OSA) in Bronchial Asthma(BA) and search for biomarkers of OSA-associated BA

Acronym

OSA merger rate in asthma

Scientific Title

Investigation of the merger ratio of Obstructive Sleep Apnea(OSA) in Bronchial Asthma(BA) and search for biomarkers of OSA-associated BA

Scientific Title:Acronym

OSA merger rate in asthma

Region

Japan


Condition

Condition

Bronchial Asthma/Obstructive Sleep Apnea

Classification by specialty

Pneumology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify OSA merger rate in bronchial asthma and biomarkers for diagnosis and treatment of OSA-associated asthma

Basic objectives2

Others

Basic objectives -Others

Survey

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

OSA merger rate in asthma

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

out-of-center sleep testing
one day

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

18 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Stable asthmatic patients
>=18 years old

Key exclusion criteria

COPD, Lung Cancer, Interstitial Pneumonia,poorly controlled heart failure, neuromuscular disease

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Kazunori
Middle name
Last name Tobino

Organization

Iizuka Hospital

Division name

Respiratory medicine

Zip code

8208505

Address

3-83 Yoshiomachi,Iizuka Fukuoka

TEL

0948223800

Email

mina0628mina@gmail.com


Public contact

Name of contact person

1st name Mina
Middle name
Last name Yasuda

Organization

Iizuka Hospital

Division name

Respiratory medicine

Zip code

8208505

Address

3-83 Yoshiomachi,Iizuka Fukuoka

TEL

0948223800

Homepage URL


Email

mina0628mina@gmail.com


Sponsor or person

Institute

department of respiratory medicine Iizuka Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of respiratory medicine Iizuka Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Iizuka Hospital

Address

3-83 Yoshiomachi,Iizuka Fukuoka

Tel

0948223800

Email

rinri@aih-net.com


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

2018 Year 09 Month 25 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


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

Open public recruiting

Date of protocol fixation

2017 Year 08 Month 22 Day

Date of IRB

2017 Year 08 Month 22 Day

Anticipated trial start date

2017 Year 08 Month 22 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2021 Year 03 Month 31 Day

Date trial data considered complete

2021 Year 03 Month 31 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 25 Day

Last modified on

2021 Year 03 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039066


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name