Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract

NCT ID: NCT00619827

Last Updated: 2016-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-03-31

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.

Conditions

Seasonal Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

300 IR

300 IR grass pollen allergen extract tablet

Group Type: EXPERIMENTAL

300 IR grass pollen allergen extract tablet

Intervention Type: DRUG

300 IR grass pollen allergen extract tablet once daily during four months

Placebo

Placebo tablet

Group Type: PLACEBO_COMPARATOR

Placebo tablet

Intervention Type: DRUG

Placebo tablet once daily during four months

Interventions

300 IR grass pollen allergen extract tablet

300 IR grass pollen allergen extract tablet once daily during four months

Intervention Type: DRUG

Placebo tablet

Placebo tablet once daily during four months

Intervention Type: DRUG

Other Intervention Names

Sublingual immunotherapy tablet; Sublingual placebo tablet

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stallergenes Greer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Friedrich HORAK, Pr. MD

Role: PRINCIPAL_INVESTIGATOR

Allergy Center Vienna West, VIENNA, AUSTRIA

Locations

Allergy Center Vienna West, Vienna Challenge Chamber -

Vienna, , Austria

Countries

Austria

References

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.

Reference Type: RESULT

PMID: 19647862 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24261946 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23181790 (View on PubMed)

Other Identifiers

VO56.07 A

Identifier Type: -

Identifier Source: org_study_id