UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The cough provocation test by mechanical stimulation to the cervical trachea with cough quatification by using mask peak flow meter.
Title of the study (Brief title)	Quantitive cough provocation test by using mask peak flow meter.
Region	Japan

Condition
Condition	bronchial asthma, cough variant asthma, btonchitis
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the utility of cough provocation test by mechanical stimulatuion to the trachea.
Basic objectives2	Others
Basic objectives -Others	Quantification of the cough strength will also be estimated by using mask-peak flow meter.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Time needed to provoke cough with vibrator before and after the therapy.
Key secondary outcomes	The strength of the provoked cough befroe and after the therapy.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	The stimulation generated by the vibrator will be applied at the cervilcal trachea up to 2 minutes and time needed to provoke cough will be recorded. The intensity of provoked cough will be estimated by mask peak flow meter. These measurement will be done before the treatment of the cough and followed after the introduction of the treatment. Visual analogue scale for cough will be recorded daily and relationship will be estimated. For the patients with asthma and cough variant asthma, pulmonary function test, ACT score and peak flow will be recorded and relationship will be estimated.
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Those with the cough symptoms which supposed to be improved by the treatment, such as bronchial asthma, cough variant asthma, bronchitis.
Key exclusion criteria	# Those with active bleeding from the airway. # Those with thoracic deformty. # Those with pneumothorax or thoraco-abdominal surgery prior to the entry to the study. # Those who are pregnant or during lactation.
Target sample size	200

Research contact person
Name of lead principal investigator	Mitsuhiro Kamimura
Organization	National Hospital Organization Disaster Medical Center
Division name	Department of Pulmonology
Address	Midorimachi 3256, Tachikawa, Tokyo
TEL	042-526-5511
Email	tdmckamimura@yahoo.co.jp

Public contact
Name of contact person	Mitsuhiro Kamimura
Organization	National Hospital Organization Disaster Medical Center
Division name	Department of Pulmonology
Address	Midorimachi 3256, Tachikawa, Tokyo
TEL	042-526-5511
Homepage URL
Email	tdmckamimura@yahoo.co.jp

Sponsor
Institute	National Hospital 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
Name of secondary funｄer(s)

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	国立病院機構災害医療センター

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 29 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 11 Month 05 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 08 Month 28 Day
Last modified on	2017 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022677