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Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis

Primary Purpose

Allergy

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
100 IR grass pollen allergen extract tablet
300 IR grass pollen allergen extract tablet
500 IR grass pollen allergen extract tablet
Placebo tablet
Sponsored by
Stallergenes Greer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergy focused on measuring Sublingual immunotherapy, Grass pollen tablet, Allergic rhinoconjunctivitis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written consent Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons. Sensitised to grass pollen (positive SPT and RAST level of at least class 2). Total symptom score of the RRTSS during the previous pollen season greater than or equal to 12. Safety laboratory resuts within the references ranges Exclusion Criteria: Pregnancy, breast-feeding/lactation Had received desensitisation treatment for grass pollen Treatment by immunotherapy with another allergen within the previous 5 years Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies Treated with beta-blockers or under continuous corticotherapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    100 IR

    300 IR

    500 IR

    Placebo

    Arm Description

    100 IR grass pollen allergen extract tablet

    300 IR grass pollen allergen extract tablet

    500 IR grass pollen allergen extract tablet

    Placebo tablet

    Outcomes

    Primary Outcome Measures

    Average Rhinoconjunctivitis Total Symptom Score
    Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment. Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 22, 2006
    Last Updated
    April 18, 2016
    Sponsor
    Stallergenes Greer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00367640
    Brief Title
    Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis
    Official Title
    Randomised,Double-blind,Placebo-controlled,Multinational,Multi-centre,Phase IIb/III Study of the Efficacy and Safety of Three Doses of Sublingual Immunotherapy (SLIT) Administered as Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2004 (undefined)
    Primary Completion Date
    September 2005 (Actual)
    Study Completion Date
    September 2005 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Stallergenes Greer

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergy
    Keywords
    Sublingual immunotherapy, Grass pollen tablet, Allergic rhinoconjunctivitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    628 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    100 IR
    Arm Type
    Experimental
    Arm Description
    100 IR grass pollen allergen extract tablet
    Arm Title
    300 IR
    Arm Type
    Experimental
    Arm Description
    300 IR grass pollen allergen extract tablet
    Arm Title
    500 IR
    Arm Type
    Experimental
    Arm Description
    500 IR grass pollen allergen extract tablet
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo tablet
    Intervention Type
    Drug
    Intervention Name(s)
    100 IR grass pollen allergen extract tablet
    Other Intervention Name(s)
    Sublingual immunotherapy tablet
    Intervention Description
    One sublingual tablet daily during 4 months before pollen season and during pollen season
    Intervention Type
    Drug
    Intervention Name(s)
    300 IR grass pollen allergen extract tablet
    Other Intervention Name(s)
    Sublingual immunotherapy tablet
    Intervention Description
    One sublingual tablet daily during 4 months before pollen season and during pollen season
    Intervention Type
    Drug
    Intervention Name(s)
    500 IR grass pollen allergen extract tablet
    Other Intervention Name(s)
    Sublingual immunotherapy tablet
    Intervention Description
    One sublingual tablet daily during 4 months before pollen season and during pollen season
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo tablet
    Other Intervention Name(s)
    Sublingual placebo tablet
    Intervention Description
    One sublingual tablet daily during 4 months before pollen season and during pollen season
    Primary Outcome Measure Information:
    Title
    Average Rhinoconjunctivitis Total Symptom Score
    Description
    Average Rhinoconjunctivitis Total Symptom Score during the pollen period while participant on treatment. Participants assessed daily, during the pollen period, 6 rhinoconjunctivitis symptoms (sneezing, rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes) each symptom is scored as follows: 0: no symptoms, 1: mild symptoms, 2: moderate symptoms, 3: severe symptoms. The sum of the 6 symptoms is the Rhinoconjunctivitis Total Symptom Score (RTSS) (range 0-18). The lower the score, the better the outcome.
    Time Frame
    Pollen period (average of 32 days in the ITT set)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Written consent Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons. Sensitised to grass pollen (positive SPT and RAST level of at least class 2). Total symptom score of the RRTSS during the previous pollen season greater than or equal to 12. Safety laboratory resuts within the references ranges Exclusion Criteria: Pregnancy, breast-feeding/lactation Had received desensitisation treatment for grass pollen Treatment by immunotherapy with another allergen within the previous 5 years Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies Treated with beta-blockers or under continuous corticotherapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alain DIDIER, Professor
    Organizational Affiliation
    Hôpital Rangueil-Larrey, Toulouse, France
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17935764
    Citation
    Didier A, Malling HJ, Worm M, Horak F, Jager S, Montagut A, Andre C, de Beaumont O, Melac M. Optimal dose, efficacy, and safety of once-daily sublingual immunotherapy with a 5-grass pollen tablet for seasonal allergic rhinitis. J Allergy Clin Immunol. 2007 Dec;120(6):1338-45. doi: 10.1016/j.jaci.2007.07.046. Epub 2007 Nov 1.
    Results Reference
    result

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    Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis

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