Clinical study on therapeutic effects of seasonal allergic rhinitis treatment sheet (HATS-03).

JRCT ID: jRCT2032190215

Registered date:18/02/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Seasonal allergic rhinitis
• Date of first enrollment: 20/02/2020
• Target sample size: 200
• Study type: Interventional

Intervention(s)

Wear of seasonal allergic rhinitis treatment sheet (HATS-03) more than 8 hours a day during the period,
and drug withdrawal during wearing of seasonal allergic rhinitis treatment sheet (HATS-03) .

Outcome(s)

• Primary Outcome: Change in nasal symptom total score (4TNSS) between each day and baseline (14 days)

Secondary Outcome

(1) Each day of the [sneezing attack score], [nasal discharge score], [nasal congestion score], [intranasal pruritus score], [eye pruritus score] and [nose-and-eye symptom total score (5TSS)] Change from baseline
(2) QOL score
1) QOL score change from the beginning of treatment period (day 0) to the end of treatment period or at the end of treatment period
2) QOL score at the end of treatment period or at the time of discontinuation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

(1) Seasonal allergic rhinitis (three main signs of paroxysmal recurrent sneezing, watery rhinorrhea, nasal congestion) for the past two years, and who is taking drug therapy or pollen antigen removal therapy (mask, nasal irrigation) .
(2) Patients with serum-specific IgE antibody (cedar score of 2 or more) and nasal eosinophil test positive.
(3) Patients with total nasal symptom score (sneezing attack score, nasal discharge score, nasal congestion score, nasal pruritus score) of 8 or more.
(4) Patients who can stop drug therapy or pollen antigen removal therapy (mask, nasal washing) for the treatment of allergic rhinitis after obtaining consent.
(5) Patients who do not take drug therapy for the treatment of allergic rhinitis within the previous 7 days, including the start of the treatment period (the date of delivery of the investigational device: day 0).
(6) From two days before the start of the treatment period (day -2) to the end date of the use of the trial device (day 14), from three prefectures (Tokyo, Kanagawa, Saitama, Chiba) Those who do not plan to leave (eg 2 day trips or 2 days and 1 night).
(7) Persons aged 20 to 65 at the time of consent acquisition.
(8) Participants who can receive explanations of the study in advance, understand the contents, and obtain the written consent of the subject oneself.

Exclude criteria

(1) Perennial allergic rhinitis patients who have nasal discharge or nasal congestion throughout the year
(2) Patients with bronchial asthma within 2 years before obtaining consent
(3) Patients who meet the following within one year before the start of the treatment period
1) Pharmacotherapy with steroids (all types)
2) Allergen immunotherapy (subcutaneous, sublingual) for the treatment of hay fever
3) Patients who have undergone surgery (including laser treatment) on the nose
(4) Patients with inflammation of the upper or lower respiratory tract, nasal diseases (nasal mushrooms, nasal septum curvature, hypertrophic rhinitis) affecting the efficacy at screening and at the beginning of the treatment period (day 0) Person who used inhibitor
(5) A person who has a skin disease or a wound on the site (nose, cheek, lips, chin) where the test device and the device holder
(6) Persons who have a predisposition to metal (silver, titanium) allergy
(7) Participants in other clinical trials within 12 weeks before obtaining consent
(8) Patients with severe liver disease, kidney disease, heart disease, blood disease and malignant tumor
(9) Pregnant and possibly pregnant (pre-menopausal women confirmed by pregnancy test), patients wishing to become pregnant or nursing during the study period
(10) Any other person judged by the investigator or investigator to be inappropriate for this study