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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stallergenes
ClinicalTrials.gov Identifier:
NCT00409409
First received: December 7, 2006
Last updated: April 18, 2016
Last verified: April 2016

December 7, 2006
April 18, 2016
December 2006
September 2007   (final data collection date for primary outcome measure)
Average Rhinoconjunctivitis Total Symptom Score (ARTSS) [ Time Frame: Pollen period (average of 38.6 days) ] [ Designated as safety issue: No ]

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.

To assess the efficacy of SLIT for grass pollen allergens on the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms sneezing, rhinorrhoea, nasal pruritus, nasal congestion, ocular pruritus and watery eyes.
Complete list of historical versions of study NCT00409409 on ClinicalTrials.gov Archive Site
Not Provided
To assess the efficacy of SLIT for grass pollen allergens on the rescue medication score and usage and to document the safety of the treatment.
Not Provided
Not Provided
 
Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Allergy
  • Drug: 300 IR grass pollen allergen extract tablet
    One sublingual tablet daily during 4 months before pollen season and during pollen season
    Other Name: Sublingual immunotherapy tablet
  • Drug: Placebo tablet
    One sublingual tablet daily during 4 months before pollen season and during pollen season
    Other Name: Sublingual placebo tablet
  • Experimental: 300 IR
    300 IR grass pollen allergen extract tablet
    Intervention: Drug: 300 IR grass pollen allergen extract tablet
  • Placebo Comparator: Placebo
    Placebo tablet
    Intervention: Drug: Placebo tablet
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
278
September 2007
September 2007   (final data collection date for primary outcome measure)

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.
Both
5 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00409409
VO52.06
No
Not Provided
Not Provided
Stallergenes
Stallergenes
Not Provided
Principal Investigator: Ulrich Wahn, Professor Charité - Campus Virchow Klinikum, Berlin, Germany
Stallergenes
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP