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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001699
Receipt No. 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

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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
Email

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
Email kamimura@tdmc.hosp.go.jp

Sponsor
Institute National 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 none
Name of secondary funder(s) none

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
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
URL(English) https://upload.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
Registered date File name


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