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: January 23, 2014
Last verified: January 2014
  Purpose

Multicenter sublingual Immunotherapy with grass pollen allergens


Condition Intervention Phase
Type I - Allergy
Drug: Grass pollen allergen extract
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

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: Solution of grass pollen allergen extract Drug: Grass pollen allergen extract
In total up to 4 drops (dose for maintenance therapy) are administered under the tongue.
Placebo Comparator: Placebo 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.

  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
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: January 23, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

ClinicalTrials.gov processed this record on April 16, 2014