Clinical trial NCT00619827: Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract
Official title: A Randomised, Double-blind, in Parallel Groups Placebo-controlled, Mono-centre, Phase I Study to Assess After Allergen Challenge in an Allergen Exposition Chamber the Effect and Its Time Course of Sublingual Immunotherapy (SLIT) Administered as 300IR Allergen-based Tablets Once Daily to Adults Suffering From Grass Pollen Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Seasonal Allergic Rhinitis
Keywords: Sublingual immunotherapy
Rhinitis
Conjunctivitis
Allergen challenge
Allergen exposition chamber
Grass pollen tablet
Allergic rhinoconjunctivitis
Lead sponsor: Stallergenes Greer
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the effect of grass pollen extract SLIT tablets on the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in response to grass pollen challenge after one week, one, two and four months of treatment in patients suffering from Seasonal Allergic Rhinoconjunctivitis (SAR) due to grass pollen.

Detailed description: The purpose of this study is to determine whether SLIT tablets are effective on symptoms of allergic rhinitis compared to placebo in patients suffering from allergic rhinitis to grass pollen when exposed in an allergen chamber and also to determine the onset of action of SLIT tablets on allergic rhinitis symptoms.

Eligibility criteria: Inclusion Criteria:

* Male or female outpatients 18-50 years old
* grass pollen rhinoconjunctivitis of at least 2 years.
* positive specific skin prick test and a specific IgE dosage level of at least 0.70 kU/L at screening.
* written consent
* a positive response to the baseline challenge test (RTSS reaches 7 at one time-point at least during baseline challenge)

Exclusion Criteria:

* Allergic rhino-conjunctivitis due to a co-sensitisation, likely to significantly change the symptoms of the subject throughout the study
* Asthma requiring treatment other than short-acting beta-2 inhaled agonists.
* Desensitisation treatment for grass pollen in the previous five years and current immunotherapy with another allergen.

Primary outcomes:
measure: Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Allergy Center Vienna West, Vienna Challenge Chamber -
Study officials:
affiliation: Allergy Center Vienna West, VIENNA, AUSTRIA
name: Friedrich HORAK, Pr. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Horak F, Zieglmayer P, Zieglmayer R, Lemell P, Devillier P, Montagut A, Melac M, Galvain S, Jean-Alphonse S, Van Overtvelt L, Moingeon P, Le Gall M. Early onset of action of a 5-grass-pollen 300-IR sublingual immunotherapy tablet evaluated in an allergen challenge chamber. J Allergy Clin Immunol. 2009 Sep;124(3):471-7, 477.e1. doi: 10.1016/j.jaci.2009.06.006. Epub 2009 Aug 3.
citation: Baron-Bodo V, Horiot S, Lautrette A, Chabre H, Drucbert AS, Danze PM, Senechal H, Peltre G, Galvain S, Zeldin RK, Horak F, Moingeon P. Heterogeneity of antibody responses among clinical responders during grass pollen sublingual immunotherapy. Clin Exp Allergy. 2013 Dec;43(12):1362-73. doi: 10.1111/cea.12187.
citation: Bonvalet M, Moussu H, Wambre E, Ricarte C, Horiot S, Rimaniol AC, Kwok WW, Horak F, de Beaumont O, Baron-Bodo V, Moingeon P. Allergen-specific CD4+ T cell responses in peripheral blood do not predict the early onset of clinical efficacy during grass pollen sublingual immunotherapy. Clin Exp Allergy. 2012 Dec;42(12):1745-55. doi: 10.1111/cea.12015.