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

This study is currently recruiting participants.

Verified by Stallergenes, December 2006

First Received: December 7, 2006 No Changes Posted

Sponsored by:	Stallergenes
Information provided by:	Stallergenes
ClinicalTrials.gov Identifier:	NCT00409409

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
Estimated 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

Contacts

Contact: Martine LE GALL	00 1 55 59 25 56	mlegall@stallergenes.fr
Contact: Michel MELAC, MD	00 1 55 59 25 28	mmelac@stallergenes.fr

Locations

Germany
Charité – Campus Virchow Klinikum	Recruiting
Berlin, Germany
Contact: Martine Legall

Sponsors and Collaborators

Stallergenes

Investigators

Principal Investigator:

Ulrich Wahn, Professor

Charité – Campus Virchow Klinikum, Berlin, Germany

More Information

No publications provided

Study ID Numbers:	VO52.06
Study First Received:	December 7, 2006
Last Updated:	December 7, 2006
ClinicalTrials.gov Identifier:	NCT00409409 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; 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

Study placed in the following topic categories:

Hypersensitivity

ClinicalTrials.gov processed this record on September 01, 2009