NCT06027073Not yet recruitingPhase 4
Biologics and Sublingual Immunotherapy
Adding Biological Therapy to Asthmatic Patients on Allergen Immunotherapy to House Dust Mites
Source: ClinicalTrials.gov · Last updated 7 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 30 Aug 2023
- Start date
- 1 May 2024
- Primary completion date
- 1 Oct 2026
- Lead sponsor
- Medical University of Silesia
- Diseases
- Asthma
- NCT number
- NCT06027073
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 150
- From 1 May 2024 to the primary completion date, 1 Oct 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Allergen immunotherapy during the past 5 years
- Contraindicating allergen immunotherapy and omalizumab treatment.
Other illness
- Other serious diseases or chronic unstable diseases
Other
- Sensitisation to other allergens with clinical signs not related to HDM
- Uncontrolled asthma,
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.