Study on symptoms and medication use in the patiants with grass pollinosis, and grass pollen counts

JRCT ID: jRCT1030230670

Registered date:29/02/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Grass pollinosis
• Date of first enrollment: 04/03/2024
• Target sample size: 200
• Study type: Observational

Outcome(s)

• Primary Outcome: From May to August, Rhinoconjunctivitis Symptom Score, Rhinoconjunctivitis Madication Score, Total Rhinoconjunctivitis Symptom and Madication Score, Proportion of the subjects used medication for symptom of pollinosis, and the daily each pollen counts from May to August, pollen are Grass, Cypress, Birch, Alder, Ragweed, Mugwort, Japanese Hop.

Key inclusion & exclusion criteria

• Age minimum: >= 5age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

(1)Male and female patients over 5 years old and under 65 years old on the day of informed consent
(2)Patients with moderate or severe nasal symptoms of nasal discharge, nasal congestion, sneezing, or itching or eye symptoms of foreign body sensation in eyes/hyperemia/itching or lacrimation outside the house (particularly in the places where weeds can be seen, such as riverbeds, fields, rice paddies, open spaces, etc.), and with requirement of medication therapy, during the recent grass pollen season (May to August)
(3)Patients who may be able to appropriately enter their condition of pollinosis in the electronic diary by smartphone or tablet device (the parents when patients are aged < 12 years on the day of informed consent)

Exclude criteria

(1)Patients who received specific immunotherapy for Grass, Cypress, Birch, Alder, Ragweed, Mugwort or Japanese Hop pollinosis for at least 1 month from within 5 years prior to the day of first observation (Visit 1) to the day of second observation (Visit 2)
(2)Patients who received laser treatment or surgery for the treatment of nasal symptoms from within 1 years prior to the day of first observation (Visit 1) to the day of second observation (Visit 2)
(3)Patients who are unlikely to complete the study or who are expected to change their living environment during the study period (e.g., moving and lifestyle changes such as higher education and employment)

Related Information

• Primary Sponsor: Kikuchi Masayo
• Source(s) of Monetary Support: Torii Pharmaceutical Co.,Ltd