Preseason administration of Japanese cedar sublingual immunotherapy after long-term use

JRCT ID: jRCTs041240112

Registered date:24/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Japanese cedar pollinosis
• Date of first enrollment: 24/10/2024
• Target sample size: 90
• Study type: Interventional

Intervention(s)

The pre-season administration group (treatment intervention group) receive pre-season Japanese cedar SLIT for total 4 months from September.
The control group discontinue Japanese cedar SLIT.

Outcome(s)

• Primary Outcome: Total nasal symptom and medication score (TNSMS) during the pollen dispersal period in the second season (Year 3) after the end of standard treatment

Secondary Outcome

Nasal symptom score (TNSS), ocular drug score (TOMS), ocular symptom score (TOSS) nasal-ocular symptom score (TNOSS), nasal-ocular drug score (TNOMS), ocular symptom drug score (TOSMS), nasal-ocular symptom drug score (TNOSMS) and quality of life score during the pollen dispersal period in the second season (Year 3) after the end of standard treatment
TNSMS, TOMS, TNSS, TOSS, TNOSS, TNOMS, TOSMS, TNOSMS and QOL scores during the pollen dispersal period in the first season (Year 2) after the end of standard treatment
Changes in cedar-specific IgE, IgG and IgG4 antibody titres from the end of standard treatment (visit 3) to 2 years later (visit 7 (discontinuation group) and visit 9 (pre-seasonal treatment group))
Adverse effects associated with oral administration of cedar sublingual tablets during the first season (Year 2) visit 4 (pre-seasonal dose group) to 4 months after completion of standard treatment and during the second season (Year 2) visit 7 (pre-seasonal dose group) to 4 months
TNSMS during the pollen dispersal period in the second season (Year 3) after the end of standard treatment for each cedar SLIT duration (3 to 4 years, 4 to 5 years, and 5 years or more at Visit 3)
TNSMS in the pollen dispersal period of the second season (Year 3) after the end of standard treatment for those aged 12 years or older or younger at the start of this study (Visit 1)
Adherence to cedar sublingual tablets during the first (Year 2) and second (Year 3) 4-month periods after completion of standard treatment in the pre-seasonal treatment group and TNSMS during the pollen dispersal period in the second season (Year 3) after completion of standard treatment

Key inclusion & exclusion criteria

• Age minimum: >= 7age old
• Age maximum: < 20age old
• Gender: Both

Include criteria

(1) Patients aged between 7 and 20 years at the start of the study (Visit 1).
(2) Patients with cedar pollinosis diagnosed by a physician.
(3) Patients with proven cedar sensitisation prior to introduction of cedar SLIT.
(4) Patients using SLIT for cedar pollinosis for at least 2 years and 8 months at the start of the study (Visit 1).
(5) Patients who obtain symptomatic relief after starting cedar SLIT and whose doctor decides that cedar SLIT can be discontinued.
(6) Patients for whom consent to participate in the study has been obtained from a surrogate or a surrogate and the individual.

Exclude criteria

(1) Patients with poorly controlled bronchial asthma (C-ACT or ACT score 19 or less) or poorly controlled atopic dermatitis (EASI score 16 or more).
(2) Patients with concomitant diseases affecting the immune system (e.g. autoimmune diseases, immune complex diseases, immunodeficiency).
(3) Patients on regular oral administration of systemic steroids or immunosuppressive drugs at the time of study entry.
(4) Patients who were using biological agents at the start of the study.
(5) Patients who are pregnant or wish to become pregnant.
(6) Patients deemed not appropriate in the judgement of the principal investigator or research associate.
(7) Patients who wish to continue or discontinue daily oral administration of cedar SLIT in the following year or later.

Related Information

• Primary Sponsor: Ebisawa Motohiro
• Source(s) of Monetary Support: National Hospital Organization