Special Drug Use-Results Survey for ACTAIR Sublingual Tablets (Long-term Use)

Not Applicable

• Conditions: Allergic rhinitis due to house dust mites

• Registration Number: JPRN-UMIN000042840
• Lead Sponsor: Shionogi & Co., Ltd.

Brief Summary

Of 538 patients in the safety analysis set, 156 patients (29.00%) experienced an ADR. Of 383 patients in the effectiveness analysis set, rhinitis severity score change from baseline [mean(SD)] was -1.1(0.8) points at 6 months (n=258) and -2.1(1.0) points at 4 years (n=104). In addition, ratings on the PGI-I scale of >=80% of the patients increased.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-24
• Study Completion: 2021-11-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 545

Inclusion Criteria

Not provided

Exclusion Criteria

NA

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events at long-term use (up to 4 years)

Secondary Outcome Measures

Name	Time	Method
Assessment of severity of allergic rhinitis (at enrollment, 6 months later, 1 year later, 2 years later, 3 years later, 4 years later and at discontinuation) and patients' global evaluation (6 months later, 1 year later, 2 years later, 3 years later, 4 years later, at discontinuation and 1 year after discontinuation) at long-term use (up to 4 years)