PRIME study

Not Applicable

• Conditions: typical seasonal allergic rhinitis during the cedar and cypress pollen seasons

• Registration Number: JPRN-jRCTs031190037
• Lead Sponsor: Hashiguchi Kazuhiro

Brief Summary

Rupatadine has been shown to be an effective and safe drug for nasal allergy symptoms induced by exposure of Japanese cedar pollen followed by cypress pollen, including a prescription of 20 mg.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-11
• Study Completion: 2019-08-10
• Results First Posted: 2019-11-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1) Patients between 20 and 60 years old (at the time of consent). Male and female.
2) Patients with specific IgE positive (class 2 to 6) against cedar pollen and cypress pollen allergens.
3) Patients who have typical seasonal allergic rhinitis during the cedar and cypress pollen seasons, for the past 2 years.
4) Patients judged as eligible by the doctor as a result of medical examination.
5) Patients who obtained consent for study participation.
6) Patients developed with nasal allergy symptoms by exposure to cedar pollen and cypress pollen in screening.

Exclusion Criteria

1) Patients with nasal disease that affects the evaluation of the study.
2) Patients complicated with perennial allergic rhinitis that is severe or needs treatment.
3) Patients who received steroid injection within 6 months before consent.
4) Patients who have received hay fever immunotherapy within 3 years before consent.
5) Patients with respiratory diseases such as bronchial asthma.
6) Patients with a history of anaphylaxis.
7) Patients who have hypersensitivity to rupatadine.
8) Patients who can not avoid taking anti-allergic drugs or treating allergy after consent.
9) Pregnant woman, lactating woman, patients who may be pregnant, or patients who plan to pregnant.
10) Patients who have participated in another clinical study within 3 months before consent.
11) Patients who the doctor judged inappropriate for the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time course of Total Nasal symptoms score (nasal discharge, sneezing, nasal obstruction)

Secondary Outcome Measures

Name	Time	Method
Time course of each Nasal symptoms score(nasal discharge, sneezing, nasal obstruction)<br>Time course of each itching score (eye,nose)<br>Sneezing number of times<br>Quantity of nasal discharge