Biologics and Sublingual Immunotherapy

Asthma, Allergic Clinical Trial

— BSIPL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06027073
• Other study ID #: CM-01966
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 1, 2024
• Est. completion date: March 1, 2028

Study information

• Verified date: August 2023
• Source: Medical University of Silesia
• Contact: Andrzej Bozek, prof
• Phone: 0048608318547
• Email: andrzejbozek[@]o2.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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, 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 1, 2028
• Est. primary completion date: October 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma, Allergic

Intervention

Biological:
• omalizumab
adding omalizumab to anti asthmatic therapy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Silesia	Centrum Medyczne Andrzej Bozek

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the effectiveness of combined therapy : omalizumab+ immunotherapy	Daily dose of inhaled steroids (changes)	3 years