Biologics and Sublingual Immunotherapy (BSIPL)

Medical University of Silesia

Status and phase: Not yet enrolling; Phase 4

Conditions: Asthma, Allergic

Treatments: Biological: omalizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06027073

CM-01966

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 4 patient groups

omalizumab

Active Comparator group

Description:

standard antiasthmatic therapy and omalizumab

Treatment:

Biological: omalizumab

oral tablet HDM-immunotherapy

Active Comparator group

Description:

standard antiasthmatic therapy and oral immunotherapy

Treatment:

Biological: omalizumab

combi therapy

Active Comparator group

Description:

standard antiasthmatic therapy and omalizumab, and oral immunotherapy

Treatment:

Biological: omalizumab

control

No Intervention group