BSIPL: Biologics and Sublingual Immunotherapy

Sponsor

Medical University of Silesia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06027073

Collaborator

Centrum Medyczne Andrzej Bożek (Other)

150

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Asthma, Allergic	Biological: omalizumab	Phase 4

Detailed 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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The randomization procedure with random selection will rely on computer-generated numbers using a computer program (Excel, version 14.2.0, 2020 Microsoft Corporation). The patients will be randomized into four groups 1:1:1:1 as follows: Group A: Xolair® Group B: Actair® Group C: Actair® and Xolair® Group D: Standard of Care (no interventional therapy).The randomization procedure with random selection will rely on computer-generated numbers using a computer program (Excel, version 14.2.0, 2020 Microsoft Corporation). The patients will be randomized into four groups 1:1:1:1 as follows:Group A: Xolair® Group B: Actair® Group C: Actair® and Xolair® Group D: Standard of Care (no interventional therapy).

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2024

Anticipated Primary Completion Date :

Oct 1, 2026

Anticipated Study Completion Date :

Mar 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: omalizumab standard antiasthmatic therapy and omalizumab	Biological: omalizumab adding omalizumab to anti asthmatic therapy
Active Comparator: oral tablet HDM-immunotherapy standard antiasthmatic therapy and oral immunotherapy	Biological: omalizumab adding omalizumab to anti asthmatic therapy
Active Comparator: combi therapy standard antiasthmatic therapy and omalizumab, and oral immunotherapy	Biological: omalizumab adding omalizumab to anti asthmatic therapy
No Intervention: control

Outcome Measures

Primary Outcome Measures

Assess the effectiveness of combined therapy : omalizumab+ immunotherapy [3 years]
Daily dose of inhaled steroids (changes)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medical University of Silesia
Centrum Medyczne Andrzej Bożek

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of Silesia

ClinicalTrials.gov Identifier:

NCT06027073

Other Study ID Numbers:

CM-01966

First Posted:

Sep 7, 2023

Last Update Posted:

Sep 7, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Medical University of Silesia

Additional relevant MeSH terms:

Asthma

Omalizumab

Study Results

No Results Posted as of Sep 7, 2023