臨床研究等提出・公開システム

Date of registration	May. 26, 2026
Last modified on	May. 26, 2026
Trial ID	jRCT1030260156

Scientific Title	Persistent cough in asthma patients study
Public Title	Persistent cough in asthma patients study

Contact for Scientific Queries	Name	Maruoka Hiroki
	Affiliation	GlaxoSmithKline K.K.
	Address	Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan
	Telephone	+81-120-561-007
	E-mail	jp.gskjrct@gsk.com
Contact for Public Queries	Name	Maruoka Hiroki
	Affiliation	GlaxoSmithKline K.K.
	Address	Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo, Japan
	Telephone	+81-120-561-007
	E-mail	jp.gskjrct@gsk.com

Recruitment status	Pending

Anticipated date of first enrollment		May. 15, 2026
Target sample size		500
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	1. A diagnosis of asthma is recorded in the DigiKar EMR data. 2. Male or female sex and aged 18 years or older (assessed using the DigiKar EMR data). 3. Prescription records for ICS/LABA/LAMA are available in DigiKar EMR data for at least 4 consecutive weeks immediately preceding the data extraction. 4. Electronic signed and dated informed consent is provided. 5. The patient is willing and able to complete the web-based survey. 6. Scores on the Morisky Medication Adherence Scale-8 (MMAS-8) are >-6; this instrument will be administered as part of the web survey.
	Exclusion Criteria	1. Current smoker or former smoker with a total lifetime smoking history of 10 years or more at the time of the web-based survey (assessed by self-reporting in the survey). 2. A confirmed diagnosis in DigiKar EMR data of another chronic respiratory disease known to be a primary cause of cough within 12 months before distribution of the web-based survey. 3. Presence of prescription records in DigiKar EMR data for six or more short-acting B2-agonist (SABA) inhalers within 12 months before distribution of the web-based survey. 4. Presence of a prescription record in DigiKar EMR data for an angiotensin-converting enzyme (ACE) inhibitor within 12 months before distribution of the web-based survey. 5. Presence of a prescription record in DigiKar EMR data for an asthma-related biological therapy within 12 weeks before distribution of the web-based survey. 6. Current participation in any interventional clinical study within 12 months before the web-based survey (assessed by self-reporting in the web-based survey).
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Asthma
Intervention(s)		None
Primary Outcome(s)		1. To determine the proportion of patients with persistent cough in a population of patients with asthma who have been receiving maintenance asthma treatment (ICSs/LABAs/LAMAs) for at least 4 consecutive weeks in a real-world Japanese clinical setting. 2. To determine the disease burden and lived experience of persistent cough in patients with asthma who have been receiving maintenance asthma treatment using qualitative interviews.
Secondary Outcome(s)		To describe Asthma control test (ACT), Cough Severity-Visual Analog Scale (CS-VAS), cough-specific QoL (LCQ), sleep quality (PSQI), work productivity activity impairment (WPAI), effect of urinary incontinence (ICIQ-SF), and the profile of rhinitis symptoms (HARQ).

Primary Sponsor	GlaxoSmithKline K.K.

Source of Monetary Support / Secondary Sponsor	GlaxoSmithKline K.K.

Name of Certified Review Board	Nihonbashi Sakura Clinic
Address	1-9-2 Kayabacho, Nihonbashi, Chuo-ku, Tokyo
Telephone	+81-3-6661-9061
E-Mail	jp.gskjrct@gsk.com
Approval Status	Approval
Date of approval	April. 22, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none