UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039344
Receipt number R000044873
Scientific Title Web-based survey of physicians on diagnosis, treatment pattern and underlying diseases in chronic cough and refractory chronic cough patients
Date of disclosure of the study information 2020/02/04
Last modified on 2021/11/16 01:26:15

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Basic information

Public title

Web-based survey of physicians on diagnosis, treatment pattern and underlying diseases in chronic cough and refractory chronic cough patients

Acronym

Web-based survey of physicians on diagnosis, treatment and underlying diseases in chronic cough

Scientific Title

Web-based survey of physicians on diagnosis, treatment pattern and underlying diseases in chronic cough and refractory chronic cough patients

Scientific Title:Acronym

Web-based survey of physicians on diagnosis, treatment and underlying diseases in chronic cough

Region

Japan


Condition

Condition

Chronic Cough

Classification by specialty

Medicine in general Chest surgery Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To describe the diagnostic and treatment pathway physicians follow to diagnose and treat chronic cough within the Japanese patient population
To describe the chronic cough patient population from a physician perspective and their complications
To describe characteristics of refractory chronic cough patients and how physicians diagnose and treat refractory chronic cough patients

Basic objectives2

Others

Basic objectives -Others

To understand the underlying diseases in the chronic cough, and the diaginosis and treatment.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Diagnosis, treatment pattern, underlying disease information from physicians familiar with chronic cough and refractory chronic cough patients

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Physicians experienced treating cough as general internal medicine, respiratory or otolaryngology physicians
Physician has treated at least ten adult chronic cough patients in the last 3 months

Key exclusion criteria

Physicians employed directly by the pharmaceutical industry
Physicians who undertake individual consulting/advisory roles to the pharmaceutical industry
Physicians previously employed by the pharmaceutical industry

Target sample size

400


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

KIATNOMARU SQUARE, 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, JAPAN

TEL

03-6272-2338

Email

takekazu.kubo@merck.com


Public contact

Name of contact person

1st name Takekazu
Middle name
Last name Kubo

Organization

MSD K. K.

Division name

Medical Affairs

Zip code

102-8667

Address

KIATNOMARU SQUARE, 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo, JAPAN

TEL

03-6272-2338

Homepage URL


Email

takekazu.kubo@merck.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

Japan


Other related organizations

Co-sponsor

NA

Name of secondary funder(s)

NA


IRB Contact (For public release)

Organization

Non-Profit Organization MINS Institutional Review Board

Address

5-20-9-401, Mita, Minato-ku, Tokyo, Japan

Tel

03-6416-1868

Email

npo-mins@j-irb.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 02 Month 04 Day


Related information

URL releasing protocol

NA

Publication of results

Published


Result

URL related to results and publications

https://www.iyaku.info/archive/up_img/1633597326-565698.pdf

Number of participants that the trial has enrolled

429

Results

429 physicians responded to about 15,968 chronic cough (CC) patients seen in the past 3 months. The proportion of patients with unexplained cause or multiple underlying diseases was significantly higher in patients with refractory CC (RCC) than non-RCC. Treatment to the underlying disease was generally performed for CC. On the other hand, more physicians tended to have intension to use non-specific therapeutic drugs such as central antitussives and off-label drugs for RCC patients than for CC patients.

Results date posted

2021 Year 11 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 10 Month 10 Day

Baseline Characteristics

All physicians of general internal medicine worked in clinics, whereas the physicians in respiratory medicine were equally distributed among clinics, university hospitals, national or public hospitals, and private hospitals. Approximately half of the otolaryngologists worked at clinics. The second common answer was private hospitals, and only a small number of otolaryngologists worked at university and national or public hospitals. The most common response to specialty was asthma for both general internal medicine and respiratory medicine. On the other hand, the most common response for otolaryngologists were allergy or sinusitis.

Participant flow

Participants were invited from the Nikkei BP Panel. In this survey, 429 physicians (general internal medicine: 108, respiratory medicine: 236, otolaryngology: 85) responded to the questionnaires on a website.

Adverse events

AE information was not collected in the study. There is also no AE accidentally collected.

Outcome measures

1) background characteristics of chronic cough and refractory chronic cough patients (gender, age groups)
2) number of patients with cough by underlying diseases
3) the most common prescribed drugs for chronic cough by underlying diseases (initial treatment, additional treatment, and treatment for refractory patients)
4) patients intended to use central antitussive
5) patients intended to drugs with reported antitussive effect (tricyclic antidepressant, antiepileptic drugs, antineuropathic pain drugs)
6) indicators of efficacy and patient's subjective symptoms used as reference for treatment decision

Plan to share IPD

NA

IPD sharing Plan description

NA


Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 12 Month 23 Day

Date of IRB

2020 Year 08 Month 20 Day

Anticipated trial start date

2020 Year 09 Month 01 Day

Last follow-up date

2020 Year 09 Month 18 Day

Date of closure to data entry

2020 Year 09 Month 22 Day

Date trial data considered complete

2020 Year 09 Month 23 Day

Date analysis concluded

2020 Year 12 Month 29 Day


Other

Other related information

NA


Management information

Registered date

2020 Year 01 Month 31 Day

Last modified on

2021 Year 11 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044873


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name