Status:
NOT_YET_RECRUITING
Biologics and Sublingual Immunotherapy
Lead Sponsor:
Medical University of Silesia
Collaborating Sponsors:
Centrum Medyczne Andrzej Bożek
Conditions:
Asthma, Allergic
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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, ad...
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 HD...
Eligibility Criteria
Inclusion
- • \>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
- 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.
Key Trial Info
Start Date :
May 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06027073
Start Date
May 1 2024
End Date
March 1 2028
Last Update
September 7 2023
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