NCT06027073

Biologics and Sublingual Immunotherapy

Adding Biological Therapy to Asthmatic Patients on Allergen Immunotherapy to House Dust Mites

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Medical University of Silesia · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Asthma, Allergic

Interventions

Type	Name	Description
BIOLOGICAL	omalizumab	adding omalizumab to anti asthmatic therapy

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-10-01
• Completion: 2028-03-01
• First posted: 2023-09-07
• Last updated: 2023-09-07