臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 17, 2024
Last modified on	Jan. 28, 2025
Trial ID	jRCT1050240216

Scientific Title	A cross-sectional web survey study to clarify reality of chronic rhinosinusitis with nasal polyps treatment satisfaction and QOL in patients with intractable ECRS patient(COMPASS study) (COMPASS study)
Public Title	COMPASS study (COMPASS study)

Contact for Scientific Queries	Name	Kawano Yoshiaki
	Affiliation	AstraZeneca K.K.
	Address	Grand Front Osaka Tower B 3-1, Ofuka-cho, Kita-ku, Osaka-city, Osaka 530-0011, JAPAN
	Telephone	+81-6-4802-3600
	E-mail	yoshiaki.kawano@astrazeneca.com
Contact for Public Queries	Name	Uchimura Hitomi
	Affiliation	AstraZeneca K.K.
	Address	Grand Front Osaka Tower B 3-1, Ofuka-cho, Kita-ku, Osaka-city, Osaka 530-0011, JAPAN
	Telephone	+81-6-4802-3600
	E-mail	hitomi.uchimura@astrazeneca.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Dec. 17, 2024
Actual date of first enrollment		Dec. 26, 2024
Target sample size		200
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Provision of signed informed consent on the website 2. Aged >=18 years at the time of answering the web survey 3. History of ECRS diagnosis more than 3 months prior to the time of answering the web survey 4. The patients who have been receiving CRS related treatment 5. The patients who have been issued a beneficiary certificate for intractable ECRS
	Exclusion Criteria	None.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender
Health Condition(s) or Problem(s) Studied		Eosinophilic Chronic Rhinosinusitis
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Proportion of patient who are satisfied with current ECRS treatment
Secondary Outcome(s)		1: Mean SNOT-22 score (total and each subdomain score) -Proportion of patients with each category of SNOT-22 total score -Proportion of patients with each category of SNOT-22 subdomain score -Proportion of patients with each SNOT-22 cough score 2: Proportion of patients with not well-controlled asthma (ACT <20) 3: Proportion of patient who are satisfied with current ECRS treatment by biologics use/non biologics use -Mean SNOT-22 score (total and each subdomain score) by biologics use/non-biologics -Proportion of patients with each category of SNOT-22 total score by biologics use/non-biologics -Proportion of patients with each category of SNOT-22 subdomain score by biologics use/non-biologics -Proportion of patients with each SNOT-22 cough score by biologics use/non-biologics -Proportion of patients with not well-controlled asthma (ACT <20) by biologics use/non-biologics

Primary Sponsor	AstraZeneca K.K.

Source of Monetary Support / Secondary Sponsor	AstraZeneca K.K.
Secondary Sponsor	Not applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Takahashi Clinic Ethics Committee
Address	Medicalhat 1F , 5-1-31 ,kitamachi ,iwaya, nada-ku, kobe-shi, Hyogo, Hyogo
Telephone	+81-78-882-6432
E-Mail	kishimoto.satoshi@neues.co.jp
Approval Status	Approval
Date of approval	Dec. 17, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Jan. 28, 2025	(this page)	Changes
2	Dec. 27, 2024	Detail	Changes
1	Dec. 17, 2024	Detail

List of change history