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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:
Stallergenes
ClinicalTrials.gov Identifier:
NCT00409409
First received: December 7, 2006
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
  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: Sublingual immunotherapy tablets of grass pollen allergen extract
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

MedlinePlus related topics: Itching
U.S. FDA Resources

Further study details as provided by Stallergenes:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 280
Study Start Date: December 2006
Study Completion Date: August 2007
  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
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
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

No publications provided

ClinicalTrials.gov Identifier: NCT00409409     History of Changes
Other Study ID Numbers: VO52.06
Study First Received: December 7, 2006
Last Updated: September 28, 2011
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

Additional relevant MeSH terms:
Stress, Psychological
Conjunctivitis
Behavioral Symptoms
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013