Assess the effectiveness of combined therapy Actair® plus Xolair compared to monotherapy with Actair® or Xolair® or standard symptomatic therapy in patients with mild or moderate allergic asthma to HDM.
Treatment duration: 24 months Follow-up duration:12 months Total duration: 36 months (not including screening and randomization period) May 2024 - March 2028 Consisting of a 4 to 5 months screening phase (with 1 month observation period prior to randomization) a treatment phase of 24 months and post-treatment follow-up phase 12 months
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
A total IgE between 30-700 IU/mL
Moderate asthma with perennial symptoms confirmed as HDM-driven asthma based on medical history and positive nasal provocation tests, partially controlled asthma;
FEV1 \>70% at baseline;
Positive skin prick test results for D. pteronyssinus, D. farinae
You may not be if
Sensitisation to other allergens with clinical signs not related to HDM
Uncontrolled asthma,
Other serious diseases or chronic unstable diseases
Allergen immunotherapy during the past 5 years
Contraindicating allergen immunotherapy and omalizumab treatment.
Clareo Health | Biologics and Sublingual Immunotherapy
