Asthma
Conditions
Keywords
Asthma, Sublingual immunotherapy, Children
Brief summary
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. The investigators 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 sublingual immunotherapy (SLIT) in children with asthma.
Detailed description
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.
Interventions
DRUGStaloral 300
Staloral 300
DRUGplacebo
placebo
Sponsors
Medical University of Lodz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* patients allergic to grasses pollen * patients with bronchial asthma * patients with controlled asthma * patients who were qualified for immunotherapy and gave written informed consent for immunotherapy
Exclusion criteria
* patients allergic for other perennial and seasonal allergens * patients with other chronic diseases that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical symptoms, reliever drugs usage, controller medication usage, lung function | all visits |
Secondary
| Measure | Time frame |
|---|---|
| chosen markers of inflammation (specific IgE, IgG4, eosinophils) | 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 | baseline visit, after 24 months (tenth visit), after 36 months (fourteenth visit) |
| bronchial hyperreactivity with methacholine | after 5 months (fifth visit), after 18 months (sixth visit), after 30 months (thirteenth visit) |
Countries
Poland
Outcome results
None listed