Safety and Efficacy of Ultra-Rush Sublingual Immunotherapy in Children With Asthma Allergic to Grass Pollen
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|ClinicalTrials.gov Identifier: NCT00518518|
Recruitment Status : Completed
First Posted : August 20, 2007
Last Update Posted : May 15, 2009
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Staloral 300 Drug: placebo||Phase 4|
Specific immunotherapy is the only causal treatment method of atopic diseases including bronchial asthma in children. Sublingual immunotherapy seems to be the most promising alternative to traditional specific subcutaneous injection immunotherapy.
The aim of the study is to assess the safety and efficacy of sublingual immunotherapy applied preseasonal and seasonal in ultra-rush scheme in children with bronchial asthma allergic to grass pollen. We will assess clinical symptoms, reliever drugs usage, lung function, chosen markers of allergic inflammation, bronchial hyperreactivity with methacholine, and presence and type of allergy after two years of SLIT in children with asthma.
After two years the study will be unblinded, all the children will be given grass pollen allergen extract for a year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Safety and Efficacy of Ultra-Rush High-Dose Sublingual Immunotherapy in Children With Asthma Allergic to Grass Pollen - Prospective, Randomized, Placebo Controlled Study.|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
|Active Comparator: 1||
Drug: Staloral 300
|Placebo Comparator: 2||
- clinical symptoms, reliever drugs usage, controller medication usage, lung function [ Time Frame: all visits ]
- chosen markers of inflammation (specific IgE, IgG4, eosinophils) [ Time Frame: 1 month after baseline visit (second visit), after 5 months (fifth visit), after 18 months (ninth visit), after 30 months (thirteenth visit) ]
- skin prick test, specific nasal provocation test with grass pollen allergen [ Time Frame: baseline visit, after 24 months (tenth visit), after 36 months (fourteenth visit) ]
- bronchial hyperreactivity with methacholine [ Time Frame: after 5 months (fifth visit), after 18 months (sixth visit), after 30 months (thirteenth visit) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00518518
|Department of Pediatrics and Allergy, Medical University of Lodz, Poland|
|Lodz, Poland, 93-513|
|Principal Investigator:||Joanna Kaczmarek, MD||Department of Pediatrics and Allergy, Medical University of Lodz, Poland|
|Study Chair:||Iwona Stelmach, MD, PhD, Prof||Department of Pediatrics and Allergy, Medical University of Lodz, Poland|