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

Phase 3

Completed

• Conditions: Allergy
• Interventions: Drug: Placebo tablet; Drug: 300 IR grass pollen allergen extract tablet

• Registration Number: NCT00409409
• Lead Sponsor: Stallergenes Greer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-07
• Study First Submitted QC: 2006-12-07
• Study First Posted: 2006-12-08
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Results First Submitted: 2016-01-25
• Status Verified: 2016-04
• Results First Submitted QC: 2016-04-18
• Last Update Submitted: 2016-04-18
• Results First Posted: 2016-05-26
• Last Update Posted: 2016-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo tablet	Placebo tablet
300 IR	300 IR grass pollen allergen extract tablet	300 IR grass pollen allergen extract tablet

Primary Outcome Measures

Name	Time	Method
Average Rhinoconjunctivitis Total Symptom Score (ARTSS)	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.

Trial Locations

Locations (1)

Charité - Campus Virchow Klinikum; 🇩🇪 Berlin, Germany