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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00841256
First received: April 22, 2008
Last updated: August 6, 2014
Last verified: January 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Allergopharma GmbH & Co. KG:

Primary Outcome Measures:
  • Changes of Symptom-Medication-Score [ Time Frame: After 1 year of treatment ] [ Designated as safety issue: No ]
    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:
  • Evaluation of the documentation of adverse events (AEs) [ Time Frame: Entire treatment period ] [ Designated as safety issue: Yes ]
    Safety of treatments during the entire treatment period.


Estimated Enrollment: 230
Study Start Date: February 2008
Estimated Study Completion Date: August 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841256

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

Additional Information:
Publications:
Responsible Party: Allergopharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00841256     History of Changes
Other Study ID Numbers: AL0506st, 2006-005911-82
Study First Received: April 22, 2008
Last Updated: August 6, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

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

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

ClinicalTrials.gov processed this record on October 19, 2014