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NCT Number: NCT06027073

Biologics and Sublingual Immunotherapy

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.

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Key information

Conditions

Asthma, Allergic Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omalizumab

Biological

adding omalizumab to anti asthmatic therapy

Primary outcomes

  1. Assess the effectiveness of combined therapy : omalizumab+ immunotherapy

    Time frame: 3 years

    Daily dose of inhaled steroids (changes)

Study contacts

Contact information is provided by the study sponsor or research team.

Andrzej Bozek, prof

CONTACT

[email protected]

0048608318547

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Collaborators

  • Centrum Medyczne Andrzej Bożek

Registry information

Official study title

Adding Biological Therapy to Asthmatic Patients on Allergen Immunotherapy to House Dust Mites

Acronym: BSIPL

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Sep 7, 2023
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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