UMIN-CTR Clinical Trial

Basic information
Public title	Antitussive effect of a chest band in patients with interstitial lung disease: a pre-post intervention study
Acronym	Antitussive effect of a chest band in patients with interstitial lung disease
Scientific Title	Antitussive effect of a chest band in patients with interstitial lung disease: a pre-post intervention study
Scientific Title:Acronym	Antitussive effect of a chest band in patients with interstitial lung disease
Region	Japan

Condition
Condition	Interstitial lung disease
Classification by specialty	Pneumology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the antitussive effect of a chest band in patients with interstitial lung disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cough intensity and frequency using a Visual Analog Scale (VAS) ranging from 0 to 100 mm.
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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	chest band (24-72 h)
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with interstitial lung disease who report that VAS scores are more than 10 mm.
Key exclusion criteria	Patients who report respiratory infection within one month, or who have postnasal drip, rhinitis, catarrhal symptoms, or asthma.
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Ryuhei Middle name Last name Sato
Organization	Kyoto University Graduate School of Human Health Science
Division name	Department of Critical Care Nursing
Zip code	606-8507
Address	53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-751-3947
Email	sato.ryuhei.2n@kyoto-u.ac.jp

Public contact
Name of contact person	1st name Ryuhei Middle name Last name Sato
Organization	Kyoto University Graduate School of Human Health Science
Division name	Department of Critical Care Nursing
Zip code	606-8507
Address	53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL	075-751-3947
Homepage URL
Email	sato.ryuhei.2n@kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kyoto Unicersity Graduate School and Faculty of Medicine, Ethics Committee
Address	Yoshida Konoe cho, Sakyo-ku, Kyoto
Tel	075-753-4680
Email	ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	3236-1
Org. issuing International ID_1	Kanazawa University
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	京都大学医学部附属病院（京都府）/Kyoto University Hospital、金沢大学附属病院（石川県）/Kanazawa University Hospital

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 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	13
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	Completed
Date of protocol fixation	2016 Year 11 Month 01 Day
Date of IRB	2017 Year 02 Month 15 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2020 Year 08 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 11 Month 25 Day
Last modified on	2021 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028767