Asthma, Allergic
Conditions
Keywords
IgE, asthma, omalizumab, immunotherapy
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
Interventions
BIOLOGICALomalizumab
adding omalizumab to anti asthmatic therapy
Sponsors
Centrum Medyczne Andrzej Bożek
Medical University of Silesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The randomization procedure with random selection will rely on computer-generated numbers using a computer program (Excel, version 14.2.0, 2020 Microsoft Corporation). The patients will be randomized into four groups 1:1:1:1 as follows: Group A: Xolair® Group B: Actair® Group C: Actair® and Xolair® Group D: Standard of Care (no interventional therapy).
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the effectiveness of combined therapy : omalizumab+ immunotherapy | 3 years | Daily dose of inhaled steroids (changes) |
Contacts
Primary ContactAndrzej Bozek, prof
Outcome results
None listed