Multicenter Trial of Sublingual Immunotherapy With a Solution of Grass Pollen Allergen Extract in Children

Phase 3

Completed

• Conditions: Allergic Rhinoconjunctivitis
• Interventions: Drug: Placebo; Biological: Grass pollen allergens in a water/glycerol solution

• Registration Number: NCT00841256
• Lead Sponsor: Allergopharma GmbH & Co. KG

Brief Summary

Evaluation of safety and efficacy of sublingual immunotherapy with grass pollen allergens formulated as solution in comparison to a symptomatic standard treatment with add on placebo in grass pollen allergic children suffering from allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma.

Detailed Description

Although highly effective, subcutaneous administration of allergens may cause inconvenience in some patients. Alternative routes, e.g. nasal and oral, have therefore been investigated to find an immunotherapy regimen largely accepted by all groups of patients, including children.

Sublingual specific immunotherapy (SLIT) may represent a more acceptable route of immunotherapy. It may be an optimal therapy option especially for children because they often fear injections.

In this study children are to be treated with a preparation of a grass pollen allergen extract in a water/glycerol solution with phosphate buffered saline in comparison to a symptomatic standard treatment with add on placebo, in order to investigate efficacy and safety of the study drug.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-04-22
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Primary Completion: 2012-06
• Study Completion: 2015-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-15
• Last Update Posted: 2015-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

• 4 - <12 years (at the time of inclusion)
• Positive SPT
• Positive EAST
• Positive CPT

Exclusion Criteria

• Serious chronic diseases
• Other perennial allergies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Water/glycerol solution with phosphate buffered saline
Immunotherapy	Grass pollen allergens in a water/glycerol solution	Grass pollen allergens in a water/glycerol solution

Primary Outcome Measures

Name	Time	Method
Changes of Symptom-Medication-Score	After 1 year of treatment	The change of the area under the curve of the symptom and medication score (SMS) from the baseline season to the season after 1 year of treatment.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the documentation of adverse events (AEs)	Entire treatment period	Safety of treatments during the entire treatment period.

Trial Locations

Locations (1)

Klinik für Paediatrie Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany