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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

April 22, 2008
August 6, 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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Allergic Rhinoconjunctivitis
  • 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
  • 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
  • Experimental: Immunotherapy
    Grass pollen allergens in a water/glycerol solution
    Intervention: Biological: Grass pollen allergens in a water/glycerol solution
  • Placebo Comparator: Placebo
    Water/glycerol solution with phosphate buffered saline
    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