- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00841256
Multicenter Trial of Sublingual Immunotherapy With a Solution of Grass Pollen Allergen Extract in Children
... 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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Berlin, Germany, 13353
- Klinik für Paediatrie Universitätsmedizin Berlin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immunotherapy
Grass pollen allergens in a water/glycerol solution
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In total up to 4 drops (dose for maintenance therapy) are administered under the tongue.
Other Names:
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Placebo Comparator: Placebo
Water/glycerol solution with phosphate buffered saline
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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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of Symptom-Medication-Score
Time Frame: 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.
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After 1 year of treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the documentation of adverse events (AEs)
Time Frame: Entire treatment period
|
Safety of treatments during the entire treatment period.
|
Entire treatment period
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ulrich Wahn, MD, Charite University, Berlin, Germany
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AL0506st
- 2006-005911-82 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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