Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in 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.

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Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Charité - Campus Virchow Klinikum

Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

300 IR grass pollen allergen extract tablet

Drug

One sublingual tablet daily during 4 months before pollen season and during pollen season

Other names: Sublingual immunotherapy tablet

Placebo Tablet

Drug

One sublingual tablet daily during 4 months before pollen season and during pollen season

Other names: Sublingual placebo tablet

Primary outcomes

Average Rhinoconjunctivitis Total Symptom Score (ARTSS)

Time frame: Pollen period (average of 38.6 days)

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.

Sponsors and collaborators

Lead sponsor

Stallergenes Greer

Industry

Registry information

Official study 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

Important dates

Study start: 2006
Primary completion: 2007
Study completion: 2007
First posted: Dec 8, 2006
Registry last updated: May 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed