UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015641
Receipt number 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 14:35:53

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

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

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 or person

Institute

National Hospital Organization Disaster Medical Center

Institute

Department

Personal name



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

Value
https://center6.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