UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017426 |
|---|---|
| Receipt number | R000018182 |
| Scientific Title | Cough related to swallowing process in asthmatic patients |
| Date of disclosure of the study information | 2015/05/06 |
| Last modified on | 2015/05/06 11:02:31 |
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Basic information
Public title
Cough related to swallowing process in asthmatic patients
Acronym
asthma and swallowing-induced cough
Scientific Title
Cough related to swallowing process in asthmatic patients
Scientific Title:Acronym
asthma and swallowing-induced cough
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In asthmatic patients, emergence of cough on swallowing is sometimes observed in daily clinical practice. We investigated the occurrence of swallowing-related cough and its characteristics among bronchial asthma.
Basic objectives2
Others
Basic objectives -Others
We investigated the occurrence of swallowing-related cough and its characteristics among bronchial asthma, and also the relationship between swallowing-related cough and cough induced by post-nasal drip.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prevalence of swallowing-related cough among the bronchial asthmatic patients.
Key secondary outcomes
The relationship between swallowing-related cough and post-nasal drip-induced cough.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The asthmatic patients who can properly answer the qustionnaire.
Those who agree to give oral informed consent.
Key exclusion criteria
Those who do not fit to the entry criteria.
Target sample size
470
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
Pulmonology Department
Zip code
Address
Midorimachi 3256, Tachikawa, Tokyo, Japan
TEL
81-42-526-5511
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
Pulmonology Department
Zip code
Address
Midorimachi 3256, Tachikawa, Tokyo, Japan
TEL
81-42-526-5511
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
| 2015 | Year | 05 | Month | 06 | 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 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
| 2005 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 05 | 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
About 25% of asthmatic patients suffer from cough during the swallowing process. Spicy and sour foods are most responsible recepies for triggering cough. Cough is mostly triggered when asthma control is poor. Swallowing-related cough was significantly related with the positive history of post nasal drip induced cough.
Management information
Registered date
| 2015 | Year | 05 | Month | 06 | Day |
Last modified on
| 2015 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018182
