UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040732 |
|---|---|
| Receipt number | R000045931 |
| Scientific Title | Utility of Hull airway reflux questionnaire for the evaluation of clinical features of severe asthma |
| Date of disclosure of the study information | 2020/06/12 |
| Last modified on | 2021/03/05 15:41:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Utility of Hull airway reflux questionnaire for the evaluation of clinical features of severe asthma
Acronym
Utility of HARQ for the evaluation of severe asthma
Scientific Title
Utility of Hull airway reflux questionnaire for the evaluation of clinical features of severe asthma
Scientific Title:Acronym
Utility of HARQ for the evaluation of severe asthma
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We hypothesize that Hull airway reflux questionnaire (HARQ), a questionnaire for assessing airway reflux sensitivity may be useful for assessing condition of asthma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will evaluate associations of Hull airway reflux questionnaire with 4 clinical features of severe asthma made by the ERS/ATS guideline.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with asthma who completed the Hull airway reflux questionnaire who visited our department of respiratory Medicine for asthma between August 2018 and July 2020.
Key exclusion criteria
(1) Smoking history of 10 pack-years, or complications of chronic obstructive pulmonary disease.
(2) Patients with other respiratory diseases that are clearly affected their respiratory status,
(3) Minors
(4) Patients who are judged to be unsuitable as subjects by researchers.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Kurokawa |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
4678601
Address
1 Kawasumi, Mizuhocho, Mizuho-ku, Nagoya-shi, Aichi 467-8601, Japan
TEL
052-853-8216
rkforresearch@gmail.com
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Kurokawa |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
4678601
Address
1 Kawasumi, Mizuhocho, Mizuho-ku, Nagoya-shi, Aichi 467-8601, Japan
TEL
052-853-8216
Homepage URL
rkforresearch@gmail.com
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Nagoya City University Hospital Clinical Trial Management Center
Address
1 Kawasumi, Mizuhocho, Mizuho-ku, Nagoya-shi, Aichi 467-8601, Japan
Tel
052-858-7215
clinical_research@med.nagoya-cu.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
名古屋市立大学大学病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not implemented
Management information
Registered date
| 2020 | Year | 06 | Month | 12 | Day |
Last modified on
| 2021 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045931
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
