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Clinical Trials/JPRN-UMIN000042840
JPRN-UMIN000042840Completed未知

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

Shionogi & Co., Ltd.0 sites545 target enrollmentStarted: December 24, 2020Last updated:
Conditions

Trial Snapshot

Phase
未知
Status
Completed
Sponsor
Enrollment
545

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
ot applicable to ot applicable (—)
Sex
All

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Investigators

Sponsor
Shionogi & Co., Ltd.

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