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

NCT ID: NCT00841256

Last Updated: 2015-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2015-08-31

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.

Conditions

Allergic Rhinoconjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Immunotherapy

Grass pollen allergens in a water/glycerol solution

Group Type: EXPERIMENTAL

Grass pollen allergens in a water/glycerol solution

Intervention Type: BIOLOGICAL

In total up to 4 drops (dose for maintenance therapy) are administered under the tongue.

Placebo

Water/glycerol solution with phosphate buffered saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo was given in the same way as the sublingual active treatment. Symptomatic standard treatment, i.e. antihistamines and glucocorticoids as well as alphamimetics is allowed during grass pollen season.

Interventions

Grass pollen allergens in a water/glycerol solution

In total up to 4 drops (dose for maintenance therapy) are administered under the tongue.

Intervention Type: BIOLOGICAL

Placebo

Placebo was given in the same way as the sublingual active treatment. Symptomatic standard treatment, i.e. antihistamines and glucocorticoids as well as alphamimetics is allowed during grass pollen season.

Intervention Type: DRUG

Other Intervention Names

Allerslit forte grasses; Comparator

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Serious chronic diseases
• Other perennial allergies

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergopharma GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulrich Wahn, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Klinik für Paediatrie Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Countries

Germany

References

Wahn U, Klimek L, Ploszczuk A, Adelt T, Sandner B, Trebas-Pietras E, Eberle P, Bufe A; SLIT Study Group. High-dose sublingual immunotherapy with single-dose aqueous grass pollen extract in children is effective and safe: a double-blind, placebo-controlled study. J Allergy Clin Immunol. 2012 Oct;130(4):886-93.e5. doi: 10.1016/j.jaci.2012.06.047. Epub 2012 Aug 29.

Reference Type: RESULT

PMID: 22939758 (View on PubMed)

Related Links

http://www.allergopharma.de

Leader in specific allergy research and therapy

https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-005911-82/DE

Click here for information about this trial in the European Clinical Trials Register

Other Identifiers

2006-005911-82

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AL0506st

Identifier Type: -

Identifier Source: org_study_id