UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010531 |
|---|---|
| Receipt number | R000012318 |
| Scientific Title | Clinical usefulness of cough monitor in cough patients |
| Date of disclosure of the study information | 2013/06/11 |
| Last modified on | 2022/11/14 14:36:20 |
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Basic information
Public title
Clinical usefulness of cough monitor in cough patients
Acronym
Clinical usefulness of cough monitor
Scientific Title
Clinical usefulness of cough monitor in cough patients
Scientific Title:Acronym
Clinical usefulness of cough monitor
Region
| Japan |
Condition
Condition
cough patients
Classification by specialty
| Pneumology | Clinical immunology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to investigate whether the Leicester cough monitor could be useful in chough patients.
Basic objectives2
Others
Basic objectives -Others
Cough recording, capsaicin cough inhalation test, Leicester Cough Questionnaire (LCQ), and spirometry will be performed in cough patients before and after their treatment.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Comparison of proportional changes of cough frequency, LCQ score, cough threshold, and FEV1 before and after the treatment for cough.
Key secondary outcomes
1. Relationships between cough frequency, LCQ score, cough threshold, and spirometry before the treatment for cough.
2. To investigate the difference patterns of cough frequency and time course in various respiratory diseases which causes cough.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cough patients at the outpatient clinic and in the hospital of Fukushima Medical University who have not been treated for their cough yet.
In addition, healthy volunteers who are non-smoker.
Key exclusion criteria
1.Patients having severe complications or having serious diseases such as cancer.
2.Pregnant women or breast feeding women
3. Patients who are unable to give informed consent.
4.Inappropriate patients judged by respiratory physician.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Junpei |
| Middle name | |
| Last name | Saito |
Organization
Fukushima Medical University, School of Medicine
Division name
Department of pulmonary Medicine
Zip code
9601101
Address
1 Hikarigaoka Fukushima
TEL
024-547-1360
junpei@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Junpei |
| Middle name | |
| Last name | Saito |
Organization
Doctor
Division name
Department of Pulmonary Medicine
Zip code
9601101
Address
1 Hikarigaoka Fukushima
TEL
024-547-1360
Homepage URL
pulmo@fmu.ac.jp
Sponsor or person
Institute
Department of Pulmonary Medicine, Fukushima Medical University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Pulmonary Medicine, Fukushima Medical University, School of Medicine
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
Ethics committee of Fukushima Medical Uiversity
Address
1 Hikarigaoka, Fukushima city, Fukushima, Japan
Tel
024- 547-1825
fmucrb@fmu.ac.jp
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
福島県立医科大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 11 | 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
| 2013 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate whether changes of cough frequency before and after couth therapy are related to the changes of LCQ and cough threshold.
Management information
Registered date
| 2013 | Year | 04 | Month | 18 | Day |
Last modified on
| 2022 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012318
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
