Biologics and Sublingual Immunotherapy

Sponsor
Medical University of Silesia
Study ID
NCT06027073
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Asthma, Allergic

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • omalizumab — BIOLOGICAL
    adding omalizumab to anti asthmatic therapy

Study Details

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.

Key Dates

Start date
May 1, 2024
Status verified
Aug 2023
Primary completion
Oct 1, 2026
Completion
Mar 1, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: omalizumab
    standard antiasthmatic therapy and omalizumab
  • Active Comparator: oral tablet HDM-immunotherapy
    standard antiasthmatic therapy and oral immunotherapy
  • Active Comparator: combi therapy
    standard antiasthmatic therapy and omalizumab, and oral immunotherapy
  • No Intervention: control

Primary Outcome Measure

Assess the effectiveness of combined therapy : omalizumab+ immunotherapy [ Time Frame: 3 years ]

Central Contacts

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