House Dust Mite Allergy Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled Study to Determine Tolerability and Safety of Different Dosages of SUBLIVAC FIX Mite Mixture in Patients With Allergic Rhinitis / Rhinoconjunctivitis Caused by House Dust Mites
Allergic rhinitis/rhinoconjunctivitis is a symptomatic disorder of the nose induced by an
immunoglobulin E (IgE) mediated inflammatory response. Treatment may involve pharmacotherapy
and specific immunotherapy (IT). IT represents the only treatment that might alter the
natural course of the disease. The amount of administered allergen is crucial for both
efficacy and safety of specific IT. SUBLIVAC FIX Mite mixture is a preparation for
sublingual IT (SLIT) and is indicated for the treatment of allergic disorders such as
allergic rhinitis and rhinoconjunctivitis, caused by sensitisation to house dust mite (HDM)
allergens.
According to the European Medicines Agency Guideline on the clinical development of products
for specific IT for the treatment of allergic diseases, products should be tested at
different dosages to provide preliminary data on safety and tolerability with regard to the
maximum tolerated dose and suitable dose escalation scheme. This trial is designed to
investigate the tolerability and safety of different dosages of SUBLIVAC FIX Mite mixture.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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