UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042772 |
|---|---|
| Receipt number | R000048819 |
| Scientific Title | Impact of refractory and unexplained chronic cough on disease burden: qualitative study |
| Date of disclosure of the study information | 2020/12/17 |
| Last modified on | 2024/02/21 16:41:29 |
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Basic information
Public title
Impact of refractory and unexplained chronic cough on disease burden: qualitative study
Acronym
Impact of refractory and unexplained chronic cough on disease burden: qualitative study
Scientific Title
Impact of refractory and unexplained chronic cough on disease burden: qualitative study
Scientific Title:Acronym
Impact of refractory and unexplained chronic cough on disease burden: qualitative study
Region
| Japan |
Condition
Condition
Refractory and unexplained chronic cough
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the knowledge, awareness, experiences and burden of refractory and unexplained chronic cough patients in Japan from qualitative data.
Basic objectives2
Others
Basic objectives -Others
To qualitatively describe subtypes of burdens such as social, physical and psychological burdens on refractory and unexplained chronic cough patients within the Japanese patient population
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
NA
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
1) Patients who have daily cough lasting more than 8 weeks.
2) Patients who have visited a doctor for chronic cough.
3)Patients who have received clinical evaluations for their chronic cough on the underlying diseases stated in Japanese guidelines such as asthma/cough variant asthma, atopic cough/laryngeal allergy, gastroesophageal reflux disease (GERD), postinfectious cough, and sinobronchial syndrome (SBS).
4) Patients who are refractory to the treatment for possible underlying diseases and continue to cough or who have chronic cough of unexplained origin even after the investigation.
5) Patients who provide written informed consent and are willing to participate in either of a 120-min focus group or a 60-min individual interview about experiences about chronic cough.
6) Patients who are 20 years and older.
Key exclusion criteria
1)Patients who is immunocompromised.
2) Patients who has been diagnosed with chronic cough resulting from invasive respiratory tract instrumentation (e.g., ventilator dependent, endotracheal intubation, tracheostomy) or due to smoking.
3) Patients who has a comorbid respiratory condition or other illness that could exacerbate symptoms of chronic cough or that, in the opinion of the investigator, would confound interview results.
4) Patients who has a recent history of substance abuse (within the past 1 year)
5) Patients who has a diagnosis of a psychiatric disorder (e.g., schizophrenia, bipolar affective disorder) that, in the opinion of the investigator, would confound interview results.
6) Patients who has been exposed to an individual experiencing symptoms related to COVID-19 (e.g., fever, cough, shortness of breath) or has tested positive for the coronavirus.*
7) Patients who has participated in a study with any investigational medicinal product in the previous 30 days.
8) Those who have difficulties in communication via online interview tools.
9) Those who have fever (to avoid patients with acute infection)
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Takekazu |
| Middle name | |
| Last name | Kubo |
Organization
MSD K.K
Division name
Medical Affairs
Zip code
102-8667
Address
KITANOMARU SQUARE, 1-13-12, Kudan-kita, Chiyoda-ku, Tokyo
TEL
03-6272-2338
ldgproject@merck.com
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Akiyama |
Organization
IQVIA Solutions Japan K.K.
Division name
Real World Evidence Solutions & HEOR
Zip code
108-0074
Address
Keikyu Dai-7 Building 4-10-8 Takanawa, Minato-ku, Tokyo
TEL
070-1640-7263
Homepage URL
takeshi.akiyama@iqvia.com
Sponsor or person
Institute
MSD K.K.
Institute
Department
Personal name
Funding Source
Organization
MSD K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3 Kitamachi, Musashino-city, Tokyo
Tel
03-6779-8166
chi-pr-ec-kitamachi@cmicgroup.com
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 17 | Day |
Related information
URL releasing protocol
NA
Publication of results
Published
Result
URL related to results and publications
https://rdcu.be/cWJWm
Number of participants that the trial has enrolled
21
Results
In the interviews of the participants with refractory and unexplained chronic cough, the most frequently used word was cough and asthma as an etiology,the words associated with change in states influence,changing,change and expressions tough,pain,hard,terrible,unpleasant were also frequently observed.Also they experienced mental/social burden,physical burden,impact on sleep and meals,impact on work and housework,impact on communication,impact on hobbies and leisure and economic burden.
Results date posted
| 2022 | Year | 10 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 10 | Month | 01 | Day |
Baseline Characteristics
A total of 21 participants (95.2% with refractory chronic cough, mean age 53.5 years, and 76.2% being males) with Leicester Cough Questionnaire mean +- standard deviation scores of physical 4.8 +- 1.1, psychological 4.4 +- 1.3, social 4.9 +- 1.4, and total 14.1 +- 3.5 were included.
Participant flow
21 participants with self-reported refractory and unexplained chronic cough were included. A 60-min online interview was conducted with each patient using a semi-structured interview guide.
Adverse events
NA
Outcome measures
To describe the knowledge, awareness, experiences and burden of refractory and unexplained chronic cough patients in Japan from qualitative data.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 18 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2020 | Year | 12 | Month | 16 | Day |
Last modified on
| 2024 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048819
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