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

April 22, 2008
January 23, 2014
February 2008
June 2012   (final data collection date for primary outcome measure)
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.
Changes of Symptom-Medication-Score [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00841256 on ClinicalTrials.gov Archive Site
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.
  • Evaluation of the documentation of adverse events (AEs) [ Designated as safety issue: Yes ]
  • Immunologic changes [ Designated as safety issue: No ]
  • Changes in specific provocation tests [ Designated as safety issue: No ]
  • Changes of Symptom-Medication-Score [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

Multicenter sublingual Immunotherapy with grass pollen allergens

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type I - Allergy
  • Drug: Grass pollen allergen extract
    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.
  • Experimental: Solution of grass pollen allergen extract
    Intervention: Drug: Grass pollen allergen extract
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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 study. J Allergy Clin Immunol. 2012 Oct;130(4):886-93.e5. doi: 10.1016/j.jaci.2012.06.047. Epub 2012 Aug 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
230
August 2014
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Serious chronic diseases
  • Other perennial allergies
Both
4 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00841256
AL0506st, 2006-005911-82
No
Allergopharma GmbH & Co. KG
Allergopharma GmbH & Co. KG
Not Provided
Principal Investigator: Ulrich Wahn, MD Charite University, Berlin, Germany
Allergopharma GmbH & Co. KG
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP