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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023800
Receipt No. R000022677
Scientific Title The cough provocation test by mechanical stimulation to the cervical trachea with cough quatification by using mask peak flow meter.
Date of disclosure of the study information 2016/08/29
Last modified on 2017/09/10

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Basic information
Public title The cough provocation test by mechanical stimulation to the cervical trachea with cough quatification by using mask peak flow meter.
Acronym Quantitive cough provocation test by using mask peak flow meter.
Scientific Title The cough provocation test by mechanical stimulation to the cervical trachea with cough quatification by using mask peak flow meter.
Scientific Title:Acronym 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
1st name
Middle name
Last name Mitsuhiro Kamimura
Organization National Hospital Organization Disaster Medical Center
Division name Department of Pulmonology
Zip code
Address Midorimachi 3256, Tachikawa, Tokyo
TEL 042-526-5511
Email 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 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)

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 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

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 Open public recruiting
Date of protocol fixation
2015 Year 11 Month 05 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000022677

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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