Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract

NCT00619827 | Completed Phase 1 Results

• 1 other identifier: VO56.07 A
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergic Rhinitis

Keywords

Sublingual immunotherapy; Rhinitis; Conjunctivitis; Allergen challenge; Allergen exposition chamber; Grass pollen tablet; Allergic rhinoconjunctivitis

Outcome Measures

Primary Outcomes (1)

• Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) ]0-4] Hours

  The primary efficacy variable was the Average of Rhinoconjunctivitis Total Symptom Score (ARTSS) during the four-hour (\]0-4\] hours) grass pollen allergen challenge at end point (after four months of treatment) of the 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes). The severity of each symptom was evaluated by the subject, before allergen exposure and every 15 minutes during allergen challenge on a scale of 0 to 3; 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms, total score range was 0 to 18. The ARTSS \]0-4\] hours was calculated as the mean of the RTSSs at each timepoint during the allergen challenge (i.e., 16 timepoints from 15 minutes to 4 hours) after 4 months of treatment (endpoint). The lower the score, the better the outcome.

  4 months

Study Arms (2)

300 IR

EXPERIMENTAL

300 IR grass pollen allergen extract tablet

Drug: 300 IR grass pollen allergen extract tablet

Placebo

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo tablet

Interventions

300 IR grass pollen allergen extract tablet DRUG

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

Also known as: Sublingual immunotherapy tablet

300 IR

Placebo tablet DRUG

Placebo tablet once daily during four months

Also known as: Sublingual placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stallergenes Greer: lead

Study Sites (1)

Allergy Center Vienna West, Vienna Challenge Chamber -

Vienna, 1150, Austria

Location

Related Publications (3)

• 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.

  PMID: 19647862 RESULT

• 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.

  PMID: 24261946 DERIVED

• 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.

  PMID: 23181790 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Rhinitis; Conjunctivitis

Interventions

Sublingual Immunotherapy

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections; Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Desensitization, Immunologic; Immunosuppression Therapy; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Results Point of Contact

• Title: Laurence Paolozzi, Medical Director
• Organization: Stallergenes

lpaolozzi@stallergenes.com

+33 (0) 1 55 59 26 33

Study Officials

• Friedrich HORAK, Pr. MD

  Allergy Center Vienna West, VIENNA, AUSTRIA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 21, 2008
• Study Start: September 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: May 23, 2016
• Results First Posted: May 23, 2016

Record last verified: 2016-04

Locations

AU (1)