UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001699 |
|---|---|
| Receipt number | R000002028 |
| Scientific Title | Cough Challenge Tests Involving Mechanical Stimulation of the Cervical Trachea |
| Date of disclosure of the study information | 2009/02/10 |
| Last modified on | 2009/02/10 10:24:27 |
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Basic information
Public title
Cough Challenge Tests Involving Mechanical Stimulation of the Cervical Trachea
Acronym
Cough Challenge Tests of the Cervical Trachea
Scientific Title
Cough Challenge Tests Involving Mechanical Stimulation of the Cervical Trachea
Scientific Title:Acronym
Cough Challenge Tests of the Cervical Trachea
Region
| Japan |
Condition
Condition
patients with cough
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate cough challenge tests by mechanical stimulation of the cervical trachea.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of positive cough provocation by applying the mechanical stimulation on cervical trachea.
Key secondary outcomes
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients visited The Disaster Medical Center because of the cough.
Key exclusion criteria
Those who do not accept the entry to the study.
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MItsuhiro Kamimura |
Organization
National Organization Disaster Medical Center
Division name
Pulmonology Department
Zip code
Address
Midorimachi 3256, Tachikawa, Tokyo
TEL
042-526-5511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Kamimura |
Organization
National Organization Disaster Medical Center
Division name
Pulmonology Department
Zip code
Address
TEL
042-526-5511
Homepage URL
kamimura@tdmc.hosp.go.jp
Sponsor or person
Institute
National 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
none
Name of secondary funder(s)
none
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
| 2009 | Year | 02 | Month | 10 | 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
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
| 2006 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 01 | Month | 01 | Day |
Other
Other related information
Three types of mechanical stimulation as cough challenge tests were tried. The cervical trachea was compressed softly with fingers several times (tracheal compression test: TCT), the trachea was stretched by retroflexion of the neck for five seconds (tracheal stretch test: TST), and a vibrating tuning fork was placed on the cervical trachea for 20 seconds (tuning fork test: TFT). The relation between phonation-induced cough and the results of these provocation tests was assessed.
The positive rate for provocation of cough was 27.7% with the TCT, 39.8% with the TST, and 36.9% with the TFT. Provocation of an itchy sensation with or without cough occurred in about 50% of subjects undergoing each test. Provocation of cough and an itchy sensation by each test was significantly more common in subjects with phonation-induced cough. The tests usually became negative after cough was improved by treatment.
Management information
Registered date
| 2009 | Year | 02 | Month | 10 | Day |
Last modified on
| 2009 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002028
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
