UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023800 |
|---|---|
| Receipt number | 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 19:14:17 |
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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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022677
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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