Adding Biological Therapy to Asthmatic Patients on Allergen Immunotherapy to House Dust Mites
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Asthma, Allergic
- Sponsor
- Medical University of Silesia
- Enrollment
- 150
- Primary Endpoint
- Assess the effectiveness of combined therapy : omalizumab+ immunotherapy
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Most current studies involve using a biological drug to increase the safety of allergen immunotherapy (AIT) especially in the treatment of food allergies, to avoid the risk of anaphylaxis. However, adding Xolair® to AIT may improve the therapy's effectiveness. There are still few observations on this topic, especially in patients with house dust mite (HDM)-driven asthma.
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •\>18 years old
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Assess the effectiveness of combined therapy : omalizumab+ immunotherapy
Time Frame: 3 years
Daily dose of inhaled steroids (changes)