PMID- 30444150
OWN - NLM
STAT- MEDLINE
DCOM- 20200511
LR  - 20200511
IS  - 1532-4303 (Electronic)
IS  - 0277-0903 (Linking)
VI  - 56
IP  - 12
DP  - 2019 Dec
TI  - Safety profile of the SQ house dust mite sublingual immunotherapy-tablet in 
      Japanese adult patients with house dust mite-induced allergic asthma: a 
      randomized, double-blind, placebo-controlled phase I study.
PG  - 1347-1355
LID - 10.1080/02770903.2018.1541353 [doi]
AB  - Objective: The SQ house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet 
      has demonstrated effective treatment of HDM-induced allergic asthma in patients 
      18 years or older in European trials. This study investigated its safety and 
      immunology profile in Japanese adult patients with mild-to-moderate HDM-induced 
      allergic asthma. Methods: In this randomized, double-blind, placebo-controlled 
      study, 48 Japanese patients were randomly assigned to a daily treatment of SQ HDM 
      SLIT-tablet or placebo (3:1) for 14 d with or without an up-dosing regimen. 
      Active groups comprised 5000, 10,000 or 20,000 Japanese Allergy Unit (JAU) for 14 
      d, and the up-dosing group comprised 5,000 JAU in day 1-3, 10,000 JAU in day 4-7 
      and 20,000 JAU in day 8-14. Results: No marked differences were observed in the 
      incidence rate of adverse events (AEs) and their severity among active groups. 
      The five most common investigational medicinal product (IMP)-related AEs were 
      local events at the application site observed within 30 min after the intake of 
      the SQ HDM SLIT-tablet. Although most events recovered within 1 h, mouth edema 
      indicated a different profile of duration with more than 25% of the events 
      lasting for more than 1 h. Conclusions: The SQ HDM SLIT-tablet of up to 20,000 
      JAU was well tolerated, and safety profile was acceptable for Japanese subjects 
      with HDM-induced allergic asthma.
FAU - Okamiya, Kazuhiro
AU  - Okamiya K
AD  - Torii Pharmaceutical Co. Ltd. , Tokyo , Japan.
FAU - Sekino, Hisakuni
AU  - Sekino H
AD  - Department of Internal Medicine, Sekino Hospital , Tokyo , Japan.
FAU - Azuma, Ryuji
AU  - Azuma R
AD  - Torii Pharmaceutical Co. Ltd. , Tokyo , Japan.
FAU - Kudo, Minoru
AU  - Kudo M
AD  - Torii Pharmaceutical Co. Ltd. , Tokyo , Japan.
FAU - Sakaguchi, Miyuki
AU  - Sakaguchi M
AD  - Torii Pharmaceutical Co. Ltd. , Tokyo , Japan.
FAU - Nemoto, Fumi
AU  - Nemoto F
AD  - Torii Pharmaceutical Co. Ltd. , Tokyo , Japan.
FAU - Muramatsu, Naoki
AU  - Muramatsu N
AD  - Torii Pharmaceutical Co. Ltd. , Tokyo , Japan.
FAU - Maekawa, Yuriko
AU  - Maekawa Y
AD  - Torii Pharmaceutical Co. Ltd. , Tokyo , Japan.
FAU - Tanaka, Akihiko
AU  - Tanaka A
AD  - Department of Medicine, Division of Respiratory Medicine and Allergology, School 
      of Medicine, Showa University , Tokyo , Japan.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20181116
PL  - England
TA  - J Asthma
JT  - The Journal of asthma : official journal of the Association for the Care of 
      Asthma
JID - 8106454
RN  - 0 (Antigens, Dermatophagoides)
RN  - 0 (Tablets)
SB  - IM
MH  - Adult
MH  - Animals
MH  - Antigens, Dermatophagoides/immunology
MH  - Asthma/diagnosis/*drug therapy/*immunology
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Japan
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - *Patient Safety
MH  - Pyroglyphidae/*immunology
MH  - Reference Values
MH  - Severity of Illness Index
MH  - Sublingual Immunotherapy
MH  - Tablets/administration & dosage
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Allergy immunotherapy
OT  - JapicCTI number 111624
OT  - atopic march
OT  - clinical trial
EDAT- 2018/11/18 06:00
MHDA- 2020/05/12 06:00
CRDT- 2018/11/17 06:00
PHST- 2018/11/18 06:00 [pubmed]
PHST- 2020/05/12 06:00 [medline]
PHST- 2018/11/17 06:00 [entrez]
AID - 10.1080/02770903.2018.1541353 [doi]
PST - ppublish
SO  - J Asthma. 2019 Dec;56(12):1347-1355. doi: 10.1080/02770903.2018.1541353. Epub 
      2018 Nov 16.