The purpose of this study is to investigate the safety and tolerability of different doses of sublingual tablets of house dust mite (HDM) allergen extracts in adolescents with house dust mite-associated allergic rhinitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
37
One sublingual tablet daily during 10 days
Two sublingual tablets daily during 10 days
Three sublingual tablets daily during 10 days
Inflamax Research Inc.
Mississauga, Ontario, Canada
Safety and Tolerability Evaluated on Treatment Emergent Adverse Events
Safety and tolerability evaluated on the number of participants who reported at least one treatment-emergent adverse event (TEAE)
Time frame: 10 dosing treatment days
Treatment Emergent Serious Adverse Events
Treatment emergent Serious Adverse Events
Time frame: 10 dosing treatment days
Adverse Events Leading to Study Withdrawal
Incidence of adverse events leading to study withdrawal
Time frame: 10 dosing treatment days
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One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets