Back to results

Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract

Primary Purpose

Seasonal Allergic Rhinitis

Status

Completed

Phase

Phase 1

Locations

Austria

Study Type

Interventional

Intervention

300 IR grass pollen allergen extract tablet

Placebo tablet

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Sublingual immunotherapy, Rhinitis, Conjunctivitis, Allergen challenge, Allergen exposition chamber, Grass pollen tablet, Allergic rhinoconjunctivitis

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Allergy Center Vienna West, Vienna Challenge Chamber -

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

300 IR

Placebo

Arm Description

300 IR grass pollen allergen extract tablet

Placebo tablet

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00619827

First Posted

February 8, 2008

Last Updated

April 18, 2016

Sponsor

Stallergenes Greer

1. Study Identification

Unique Protocol Identification Number

NCT00619827

Brief Title

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

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

March 2008 (Actual)

Study Completion Date

March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stallergenes Greer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seasonal Allergic Rhinitis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

89 (Actual)

8. Arms, Groups, and Interventions

Arm Title

300 IR

Arm Type

Experimental

Arm Description

300 IR grass pollen allergen extract tablet

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo tablet

Intervention Type

Drug

Intervention Name(s)

300 IR grass pollen allergen extract tablet

Other Intervention Name(s)

Sublingual immunotherapy tablet

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo tablet

Other Intervention Name(s)

Sublingual placebo tablet

Intervention Description

Placebo tablet once daily during four months

Primary Outcome Measure Information:

Title

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

Description

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Friedrich HORAK, Pr. MD

Organizational Affiliation

Allergy Center Vienna West, VIENNA, AUSTRIA

Official's Role

Principal Investigator

Facility Information:

Facility Name

Allergy Center Vienna West, Vienna Challenge Chamber -

City

Vienna

ZIP/Postal Code

1150

Country

Austria

12. IPD Sharing Statement

Citations:

PubMed Identifier

19647862

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.

Results Reference

result

PubMed Identifier

24261946

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.

Results Reference

derived

PubMed Identifier

23181790

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.

Results Reference

derived

Learn more about this trial

Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract

We'll reach out to this number within 24 hrs