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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00841256
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : October 16, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Allergic Rhinoconjunctivitis Biological: Grass pollen allergens in a water/glycerol solution Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Bee pollen

Arm Intervention/treatment
Experimental: Immunotherapy
Grass pollen allergens in a water/glycerol solution
Biological: Grass pollen allergens in a water/glycerol solution
In total up to 4 drops (dose for maintenance therapy) are administered under the tongue.
Other Name: Allerslit forte grasses

Placebo Comparator: Placebo
Water/glycerol solution with phosphate buffered saline
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.
Other Name: Comparator

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Evaluation of the documentation of adverse events (AEs) [ Time Frame: Entire treatment period ]
    Safety of treatments during the entire treatment period.

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Serious chronic diseases
  • Other perennial allergies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00841256

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Klinik für Paediatrie Universitätsmedizin Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
Allergopharma GmbH & Co. KG
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Principal Investigator: Ulrich Wahn, MD Charite University, Berlin, Germany

Additional Information:
Publications of Results:
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Responsible Party: Allergopharma GmbH & Co. KG Identifier: NCT00841256     History of Changes
Other Study ID Numbers: AL0506st
2006-005911-82 ( EudraCT Number )
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015

Keywords provided by Allergopharma GmbH & Co. KG:
specific immunotherapy

Additional relevant MeSH terms:
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Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Pharmaceutical Solutions
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs