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a prospective, randomized, open study of oral Cry j1-galactomannan conjugate immunotherapy for Japanese cedar pollen allergy

Phase 2
Conditions
Japanese cedar pollen allergy
Registration Number
JPRN-UMIN000013408
Lead Sponsor
Department of Otorhinolaryngology, Graduate School of Medical Sciences, Kyushu University
Brief Summary

Participants receiving OIT treatment showed significant improvements in total symptom scores, medication score, and total symptom-medication scores through the pollen season compared with control group. The levels of allergen-specific serum IgG4 in individuals were significantly increased in the OIT group, but not the control group through cedar pollen season. Importantly, no severe adverse effects were observed in participants receiving OIT treatment. (Allergol Int 64:161-168, 2015) Participants receiving OIT showed significant improvements in the total QOL score and VAS throughout the pollen season compared with the control group. In addition, the mean total QOL score and VAS correlated in both groups during the pollen season.(Auris Nasus Larynx 43: 50-55, 2016)

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
40
Inclusion Criteria

Not provided

Exclusion Criteria

Exclusion criteria were as follows: severe asthma, chronic sinusitis, previous immunotherapy or ongoing immunotherapy with other allergens, treatment with B-blockers or participants on continuous corticosteroids, pregnancy or planned pregnancy, participation in another clinical trial, and the standard contraindications for immunotherapy.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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