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
2 other identifiers
interventional
207
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2008
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 22, 2008
CompletedFirst Posted
Study publicly available on registry
February 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedOctober 16, 2015
October 1, 2015
4.3 years
April 22, 2008
October 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes of Symptom-Medication-Score
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.
After 1 year of treatment
Secondary Outcomes (1)
Evaluation of the documentation of adverse events (AEs)
Entire treatment period
Study Arms (2)
Immunotherapy
EXPERIMENTALGrass pollen allergens in a water/glycerol solution
Placebo
PLACEBO COMPARATORWater/glycerol solution with phosphate buffered saline
Interventions
In total up to 4 drops (dose for maintenance therapy) are administered under the tongue.
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 Criteria
You may qualify if:
- Positive SPT
- Positive EAST
- Positive CPT
You may not qualify if:
- Serious chronic diseases
- Other perennial allergies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinik für Paediatrie Universitätsmedizin Berlin
Berlin, State of Berlin, 13353, Germany
Related Publications (1)
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.
PMID: 22939758RESULT
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Ulrich Wahn, MD
Charite University, Berlin, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2008
First Posted
February 11, 2009
Study Start
February 1, 2008
Primary Completion
June 1, 2012
Study Completion
August 1, 2015
Last Updated
October 16, 2015
Record last verified: 2015-10