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

Allergic Rhinoconjunctivitis Clinical Trial

Official title:

... Study to Evaluate Efficacy and Safety of Perennial Sublingual SIT With a Solution of Grass Pollen Allergen ... in Children With Clinically Relevant Grass Pollen Sensitivity in Comparison to a ... Standard Treatment With Add on Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841256
• Other study ID #: AL0506st
• Secondary ID: 2006-005911-82
• Status: Completed
• Phase: Phase 3
• First received: April 22, 2008
• Last updated: October 15, 2015
• Start date: February 2008
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Allergopharma GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: August 2015
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 11 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis, Allergic

Intervention

Biological:
• Grass pollen allergens in a water/glycerol solution
In total up to 4 drops (dose for maintenance therapy) are administered under the tongue.

Drug:
• 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.

Locations

Country	Name	City	State
Germany	Klinik für Paediatrie Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Allergopharma GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Symptom-Medication-Score	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.	After 1 year of treatment	No
Secondary	Evaluation of the documentation of adverse events (AEs)	Safety of treatments during the entire treatment period.	Entire treatment period	Yes

External Links

•   Click here for information about this trial in the European Clinical Trials Register
•   Leader in specific allergy research and therapy