Biologics and Sublingual Immunotherapy

Phase 4

Not yet recruiting

• Conditions: Asthma, Allergic
• Interventions: Biological: omalizumab

• Registration Number: NCT06027073
• Lead Sponsor: Medical University of Silesia

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

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-30
• Study First Submitted QC: 2023-08-30
• Last Update Submitted: 2023-08-30
• Study First Posted: 2023-09-07
• Last Update Posted: 2023-09-07
• Study Start: 2024-05-01
• Primary Completion: 2026-10-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combi therapy	omalizumab	standard antiasthmatic therapy and omalizumab, and oral immunotherapy
oral tablet HDM-immunotherapy	omalizumab	standard antiasthmatic therapy and oral immunotherapy
omalizumab	omalizumab	standard antiasthmatic therapy and omalizumab

Primary Outcome Measures

Name	Time	Method
Assess the effectiveness of combined therapy : omalizumab+ immunotherapy	3 years	Daily dose of inhaled steroids (changes)