Skip to content

PRIME study

The Potency of Rupatadine fumarate on nasal symptoms Induced by Multiple pollen Exposure in the OHIO chamber. - PRIME study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031190037
Enrollment
45
Registered
2019-06-11
Start date
2019-06-15
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

typical seasonal allergic rhinitis during the cedar and cypress pollen seasons

Interventions

arm A: Rupatadine 10mg administered to 15 subjects once daily at Japanese cedar pollen exposure. The next day (at cypress pollen exposure), also Rupatadine 10mg administered once daily. arm B: Rupata

Sponsors

Hashiguchi Kazuhiro
Lead Sponsor
Mitsubishi Tanabe Pharma Corporation
Collaborator
Teikoku Seiyaku Co., Ltd
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Time course of Total Nasal symptoms score (nasal discharge, sneezing, nasal obstruction)

Secondary

MeasureTime frame
Time course of each Nasal symptoms score(nasal discharge, sneezing, nasal obstruction) Time course of each itching score (eye,nose) Sneezing number of times Quantity of nasal discharge

Contacts

Public ContactKazuhiro Hashiguchi

Shinanozaka Clinic

futaba-hashi@h00.itscom.net+81-3-5366-3006

Outcome results

None listed

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