Medical University of Silesia
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.
Asthma, Allergic
omalizumab
PHASE4
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
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 150 participants |
| Masking : | NONE |
| Primary Purpose : | TREATMENT |
| Official Title : | Adding Biological Therapy to Asthmatic Patients on Allergen Immunotherapy to House Dust Mites |
| Actual Study Start Date : | 2024-05-01 |
| Estimated Primary Completion Date : | 2026-10-01 |
| Estimated Study Completion Date : | 2028-03-01 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years to 65 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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