PMID- 16409193
OWN - NLM
STAT- MEDLINE
DCOM- 20060622
LR  - 20061115
IS  - 0105-4538 (Print)
IS  - 0105-4538 (Linking)
VI  - 61
IP  - 2
DP  - 2006 Feb
TI  - Safety of a SQ-standardised grass allergen tablet for sublingual immunotherapy: a 
      randomized, placebo-controlled trial.
PG  - 181-4
AB  - BACKGROUND: Sublingual treatment of grass pollen induced rhinoconjunctivitis 
      might provide easier access to specific immunotherapy (SIT) and minimize the risk 
      of serious adverse events (AEs) compared to subcutaneous SIT. AIM OF THE STUDY: 
      To identify a safe dose range for once-daily administration of a grass allergen 
      tablet in participants with grass pollen induced seasonal rhinoconjunctivitis. 
      METHODS: A randomized, double blind, placebo-controlled Phase I trial was 
      conducted outside the grass pollen season. Seven dosage groups [25,000, 75,000, 
      150,000, 300,000, 500,000, 750,000, or 1,000,000 standardized quality tablet 
      (SQ-T)], consisting of 12 participants randomized either to active treatment or 
      placebo (3 : 1) daily for 28 days, commenced treatment in a staggered manner at 
      intervals of approximately 1 week to allow for intermittent safety reviews. 
      RESULTS: The grass allergen tablet did not cause any serious, systemic or 
      significant (leading to withdrawal) AEs. The overall incidence of AEs was 74% 
      (1,013 events); all of mild or moderate intensity and most considered 
      treatment-related. The most frequently reported treatment-related AEs, including 
      irritation of the throat, and itching sensations in the mouth and ears, increased 
      with dose. These were primarily mild in intensity, started shortly after 
      medication intake and lasted for minutes to a few hours maximum. Objective oral 
      findings were also dose-dependent. No clinically significant observations were 
      found in safety laboratory, vital signs and 12-lead ECG. CONCLUSIONS: A 
      sublingual grass allergen tablet in doses up to 1,000,000 SQ-T daily caused no 
      serious or systemic AEs displaying a safety profile that allows further 
      investigation as once-daily self-medication.
FAU - Kleine-Tebbe, J
AU  - Kleine-Tebbe J
AD  - Allergy and Asthma Center Westend, Berlin, Germany.
FAU - Ribel, M
AU  - Ribel M
FAU - Herold, D A
AU  - Herold DA
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Denmark
TA  - Allergy
JT  - Allergy
JID - 7804028
RN  - 0 (Allergens)
RN  - 0 (Tablets)
SB  - IM
MH  - *Administration, Sublingual
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Allergens/*administration & dosage/adverse effects
MH  - Desensitization, Immunologic/*methods
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Humans
MH  - Injections, Subcutaneous
MH  - Male
MH  - Middle Aged
MH  - Poaceae/*immunology
MH  - Pollen/*adverse effects
MH  - Rhinitis, Allergic, Seasonal/*prevention & control
MH  - Tablets
EDAT- 2006/01/18 09:00
MHDA- 2006/06/23 09:00
CRDT- 2006/01/18 09:00
PHST- 2006/01/18 09:00 [pubmed]
PHST- 2006/06/23 09:00 [medline]
PHST- 2006/01/18 09:00 [entrez]
AID - ALL959 [pii]
AID - 10.1111/j.1398-9995.2006.00959.x [doi]
PST - ppublish
SO  - Allergy. 2006 Feb;61(2):181-4. doi: 10.1111/j.1398-9995.2006.00959.x.