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Clinical effectiveness of 2nd generation antihistamine (Observational Study)

Clinical effectiveness of 2nd generation antihistamine (Observational Study) - Clinical effectiveness of 2nd generation antihistamine (Observational Study)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000025948
Enrollment
40
Registered
2017-02-01
Start date
2017-02-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal allergic rhinitis

Interventions

None listed

Sponsors

Ito ENT Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria at the visit1: (1) Patients who have been diagnosed over 2 years ago with allergic rhinitis to Japanese cedar or other pollens (2) Patients aged 20 or older and younger than 80 years (3) Patients with a T4NSS (sneezing, rhinorrhoea, nasal congestion, nasal itching) of 8 or more remaining after at least 2 weeks of taking non-tricyclic structural second generation antihistamic drug, where there is a plan to switch to tricyclic structural antihistamic drug (4) Patients who can provide written consent for participation in this study themselves and of their own free will with sufficient understanding after receiving sufficient explanation (5) Patients without communication problems

Exclusion criteria

Exclusion criteria: Patients who meet the following conditions (at Visit 1) are not selected as subjects: (1) Patients who have been treated with allergen immunotherapy (2) Patients with abnormal nasal cavity morphology such as nasal polyps or deviated nasal septum (3) Patients with severe liver or kidney dysfunction (4) Patients who are pregnant, breastfeeding, or desire pregnancy during the study period (5) In addition, patients who are judged to be inappropriate as subjects by the researcher

Design outcomes

Primary

MeasureTime frame
Change in T4NSS (sneezing, rhinorrhoea, nasal congestion, nasal itching) from week 0 (Visit 1) to week 4 (Visit 3)

Secondary

MeasureTime frame
(1) Symptoms, QOL - T4NSS sub-score: score at each visit - Score of JRQLQ No.1 items I & II - Overall condition: face scale of JRQLQ No.1 items III (2) Treatment satisfaction - Treatment satisfaction percentage in questionnaire Other evaluation (3) Adverse events

Countries

Japan

Contacts

Public ContactNobuhide Mori

Mebix, Inc. Research Promotion Group

no-mori@mebix.co.jp03-4362-4504

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026