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
  Purpose
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.

Condition Intervention Phase
Allergy
Drug: 300 IR grass pollen allergen extract tablet
Drug: Placebo tablet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Stallergenes:

Primary Outcome Measures:
  • 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.



Enrollment: 278
Study Start Date: December 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 300 IR
300 IR grass pollen allergen extract tablet
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
Placebo Comparator: Placebo
Placebo tablet
Drug: Placebo tablet
One sublingual tablet daily during 4 months before pollen season and during pollen season
Other Name: Sublingual placebo tablet

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409409

Locations
Germany
Charité - Campus Virchow Klinikum
Berlin, Germany
Sponsors and Collaborators
Stallergenes
Investigators
Principal Investigator: Ulrich Wahn, Professor Charité - Campus Virchow Klinikum, Berlin, Germany
  More Information

Publications:
Responsible Party: Stallergenes
ClinicalTrials.gov Identifier: NCT00409409     History of Changes
Other Study ID Numbers: VO52.06 
Study First Received: December 7, 2006
Results First Received: January 25, 2016
Last Updated: April 18, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
Germany: Paul-Ehrlich-Institut
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Denmark: Danish Medicines Agency

Keywords provided by Stallergenes:
Sublingual immunotherapy
Grass pollen tablet
Allergic rhinoconjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 21, 2016