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Japanese

Dec. 17, 2024

Dec. 05, 2025

jRCT1050240216

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)

COMPASS study (COMPASS study)

Jan. 27, 2025

150

The mean age of patients (standard deviation [SD]) was 54.4 (11.2) years (range: 23-78 years), and 106 (70.7%) patients were men. The proportion of patients using biologics for ECRS treatment was 51.3%, and 68.8% received treatment for >= 1 year. Four or more prescription drugs were used by 22% of patients, and 21.3% were over the counter (OTC) users. Short-term OCS use occurred in 49.3% of the patients in the past year. The proportion of patients using NSAIDs prescribed by physicians was 29.3%, that for OTC NSAIDs users was 18.7%, and that for patients not using NSAIDs was 56.0%.

Overall, 541 patients who provided informed consent to participate were eligible for inclusion in the study. Of these, 391 who did not meet the criteria were excluded. Regarding the definition of FAS, there were no withdrawals of consent or invalid responses. The remaining 150 participants were enrolled in the FAS.

Not applicable

< Primary endpoint > The primary endpoint was defined as the proportion of the sum of Satisfied and Mostly satisfied patients. Overall satisfaction with the current ECRS treatment was 61.3%. The highest responses were mostly satisfied (38.7%) followed by Satisfied (22.7%). < Secondary endpoints > 1. Total score and each domain score of SNOT-22 The summary (statistic) of the total score and each subdomain score of SNOT-22 was 24.3 (18.9). The mean (SD) by the domain score of SNOT-22 was 10.7 (7.3) for nasal, 1.7 (2.5) for the ear, 4.8 (4.6) for sleep, 5.1 (4.9) for general symptoms, 2.0 (2.9) for emotional consequences, and 1.4 (1.3) for cough scores. 2. ACT score Patient-reported control of asthma symptoms using the ACT score is shown in below. The most frequent score was 25 (34.7%), and scores of 20-25 accounted for 75.3% of the total. The proportion of patients with a total ACT score <20 (poorly controlled asthma) was 24.7%. 3. Overall satisfaction, QOL, and asthma control according to biologic use/non-use First, regarding the proportion of patients for each option for overall satisfaction with ECRS treatment in subgroups of the patients with biologics use/non-use, Satisfied or Mostly satisfied" were answered by 68.8% in biologic users and 53.4% in non-biologics users, with a higher score in biologic users. Secondary, the summary statistics of the total score and each subdomain score of SNOT-22 in subgroups of patients with biologic use/non-use, the mean (SD) total score of SNOT-22 was 23.7 (19.5) for biologic use and 24.9 (18.4) for non-biologic use. There were no differences in the total score or each subdomain score between the two groups. The normalized mean score(mean/maximum scores) by the subdomain were 28.9 in biologic users and 32.2 in non-biologic users for the nasal subdomain, and 28.1 in biologic users and 27.9 in non-biologic users for the cough subdomain. Finally, Patient-reported control of asthma symptoms using the ACT score in subgroups of patients with biologic use/non-use of total ACT score <20 (poorly controlled asthma) was 29.9% in biologic users and 19.2% in non-biologics users.

In Japan, treatment satisfaction among patients with ECRS and a certified intractable disease is about 60%. Many of these patients have multiple factors contributing to symptom worsening. They suffer from both nasal symptoms and coughing, which impairs their QOL. The most common reason for satisfaction was improved symptoms, followed by better asthma control. Further improvement in ECRS control is expected by using biologics appropriately and addressing factors that aggravate ECRS symptoms.

Jan. 05, 2026

Yes

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

https://jrct.mhlw.go.jp/latest-detail/jRCT1050240216

Kawano Yoshiaki

AstraZeneca K.K.

Grand Front Osaka Tower B 3-1, Ofuka-cho, Kita-ku, Osaka-city, Osaka 530-0011, JAPAN

+81-6-4802-3600

yoshiaki.kawano@astrazeneca.com

Uchimura Hitomi

AstraZeneca K.K.

Grand Front Osaka Tower B 3-1, Ofuka-cho, Kita-ku, Osaka-city, Osaka 530-0011, JAPAN

+81-6-4802-3600

hitomi.uchimura@astrazeneca.com

Complete

Dec. 17, 2024

Dec. 26, 2024
200

Observational

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

None.

18age old over
No limit

Eosinophilic Chronic Rhinosinusitis

Proportion of patient who are satisfied with current ECRS treatment

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

AstraZeneca K.K.
AstraZeneca K.K.
Not applicable
Takahashi Clinic Ethics Committee
Medicalhat 1F , 5-1-31 ,kitamachi ,iwaya, nada-ku, kobe-shi, Hyogo, Hyogo

+81-78-882-6432

kishimoto.satoshi@neues.co.jp
Approval

Dec. 17, 2024

none

History of Changes

No Publication date
4 Jan. 05, 2026 (this page) Changes
3 Jan. 28, 2025 Detail Changes
2 Dec. 27, 2024 Detail Changes
1 Dec. 17, 2024 Detail