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Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis

Primary Purpose

Allergy

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
300 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

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female outpatients aged 5 to 17 years.
  • Written consent / assent.
  • Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
  • Sensitised to grass pollen (positive SPT and grass pollen-specific IgE values of at least Class 2).
  • Total symptom score on the Retrospective RTSS during the previous pollen season of greater than or equal to 12.

Exclusion Criteria:

  • Patients who have received any desensitisation treatment for grass pollen.

Sites / Locations

  • Charité - Campus Virchow Klinikum

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 Rhinoconjunctivitis Total Symptom Score (ARTSS)
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
December 7, 2006
Last Updated
April 18, 2016
Sponsor
Stallergenes Greer
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1. Study Identification

Unique Protocol Identification Number
NCT00409409
Brief Title
Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis
Official Title
A Randomised, Double-blind, Placebo-controlled, Multi-national, Multi-centre, Phase III Paediatric Study of the Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Administered as Allergen-based Tablets Once Daily to Children Suffering From Grass Pollen Rhinoconjunctivitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (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
A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
278 (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
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 (ARTSS)
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 38.6 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female outpatients aged 5 to 17 years. Written consent / assent. Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons. Sensitised to grass pollen (positive SPT and grass pollen-specific IgE values of at least Class 2). Total symptom score on the Retrospective RTSS during the previous pollen season of greater than or equal to 12. Exclusion Criteria: Patients who have received any desensitisation treatment for grass pollen.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrich Wahn, Professor
Organizational Affiliation
Charité - Campus Virchow Klinikum, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité - Campus Virchow Klinikum
City
Berlin
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
19046761
Citation
Wahn U, Tabar A, Kuna P, Halken S, Montagut A, de Beaumont O, Le Gall M; SLIT Study Group. Efficacy and safety of 5-grass-pollen sublingual immunotherapy tablets in pediatric allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2009 Jan;123(1):160-166.e3. doi: 10.1016/j.jaci.2008.10.009. Epub 2008 Nov 29.
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Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis

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