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 |
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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
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
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
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
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
