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

JRCT ID: jRCT2032200415

Registered date:12/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Seasonal allergic rhinitis
• Date of first enrollment: 12/03/2021
• Target sample size: 240
• Study type: Interventional

Intervention(s)

Device used during screening term: To wear a black sheet without Hydro silver titaniums with a holder, in principle, for more than 8 hours a day and continue one sheet per day for 7 days.
Clinical trial devices: To wear a blue sheet with or without Hydro silver titaniums attached to a holder, in principle, for more than 8 hours a day and continue one sheet per day for 14 days.

Outcome(s)

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

Secondary Outcome

(1) Amount of change of scores in 'number of sneeze attack', 'nasal discharge', 'nasal congestion', 'nasal irritation' and '5TSS' from baseline scores (total 14 days)
(2) QOL score
1) QOL score change from the beginning of treatment period (day 0) to the end of treatment period (day 15) 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)
(3) Patients with more than 8 points in total nasal symptom score (sneezing attack score, nasal discharge
score, nasal congestion score, nasal pruritus score, i.e. 4TNSS) on the day of screening commencement by
principal- or sub- investigators.
(4) Patients with more than 7 points of 4 TNSS baseline scores and more than 2 points of of nasal conges-
tion scorerecorded in e-PROn 4TNSS.
(5) Patients who can stop drug therapy or pollen antigen removal therapy (mask, nasal washing) for the treatment of allergic rhinitis after obtaining consent.
(6) 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).
(7) From the starting date of screening through treatment period and to the end date of the use of the trial
device (day 14), patients who do not have plans to go outside three prefectures (Tokyo, Kanagawa,
Saitama, Chiba) for more than 3 days (eg 2 day trips or 2 days and 1 night).
(8) Patients who can enter subjective symotoms into e-PRO by themselves
(9) Persons aged 20 to 65 at the time of consent acquisition.
(10) 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) Allergen immunotherapy (subcutaneous, sublingual) for the treatment of hay fever. Provided that ; those who used steroid collunarium during ceder pollinosis season (January to May) are excluded.
2) 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) or Person who used immunological suppressor
(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) Participants in other clinical trials within 12 weeks before obtaining consent
(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

Related Information

• Primary Sponsor: Okazaki Narumi