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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015641
Receipt No. R000018122
Scientific Title The Effects of Daily Bathing on the Symptoms of the Patients with Bronchial Asthma
Date of disclosure of the study information 2014/11/09
Last modified on 2014/11/09

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Basic information
Public title The Effects of Daily Bathing on the Symptoms of the Patients with Bronchial Asthma
Acronym Bathing and Asthma
Scientific Title The Effects of Daily Bathing on the Symptoms of the Patients with Bronchial Asthma
Scientific Title:Acronym Bathing and Asthma
Region
Japan

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

Objectives
Narrative objectives1 To investigate the situation concerning of the change of the symptoms and its degree by bathing in asthmatic patients.
Basic objectives2 Others
Basic objectives -Others Also we investigated the relationship between the history of bathing-induced asthma exacerbation and that of paradoxycal bronchoconstriction.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Frequency of exacerbation, improvement of asthmatic symptoms by bathing.
Key secondary outcomes Frequency of paradoxycal bronchoconstriction in exacerbation group, impvoved group, and no change group of asthmatic symptoms by bathing.

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
15 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Bronchial asthma who can properly answer the quetionnaire.
Key exclusion criteria Those who cannot answer or denied to answer the quetionnarie.
Target sample size 250

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Kamimura
Organization National Hospital Organization Disaster Medical Center
Division name Department of Pulmonology
Zip code
Address Midorimachi3256, Tachikawa, Tokyo, Japan
TEL 042-526-5511
Email tdmckamimura@yahoo.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Mitsuhiro Kamimura
Organization National Hospital Organization Disaster Medical Center
Division name Department of Pulmonology
Zip code
Address Midorimachi3256, Tachikawa, Tokyo, Japan
TEL 042-526-5511
Homepage URL
Email tdmckamimura@yahoo.co.jp

Sponsor
Institute National Hospital Organization Disaster Medical Center
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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
2014 Year 11 Month 09 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results: Two hundred and fifteen cases were recruited. Sixty cases (27.9%) experienced the appearance of the asthmatic symptom. The extent of the symptoms included 20 cases of chest discomfort (33.3%), 19 cases of cough (31.7%), and 21 cases of wheezing (35.0%). The triggering factors included vapor inhalation (32 cases, 53.3%), hydrostatic pressure on the thorax due to body immersion in the bathtub (26 cases, 43.3%), followed by sudden change of the air temperature (16 cases, 26.7%). Thirty-eight cases (17.7%) experienced the improvement of their active asthmatic symptoms by bathing. The vapor inhalation was the most common contributing factor (34 cases, 89.5%), followed by warming whole body (13 cases, 34.2%). There were no relationship between asthma severity and the appearance of the bathing-induced symptoms or improvement of active asthmatic symptoms by bathing.
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
2011 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Conclusion: The effects of bathing to asthmatic patients widely differed from patient to patient and its etiology includes several factors. For those who suffer from bathing-induced asthma symptoms, the preventive methods such as premedication of bronchodilators before bathing should be established.

Management information
Registered date
2014 Year 11 Month 09 Day
Last modified on
2014 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018122

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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