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Biologics and Sublingual Immunotherapy (BSIPL)

Primary Purpose

Asthma, Allergic

Status

Not yet recruiting

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

omalizumab

About this trial

This is an interventional treatment trial for Asthma, Allergic focused on measuring IgE, asthma, omalizumab, immunotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Arm Label

omalizumab

oral tablet HDM-immunotherapy

combi therapy

control

Arm Description

standard antiasthmatic therapy and omalizumab

standard antiasthmatic therapy and oral immunotherapy

standard antiasthmatic therapy and omalizumab, and oral immunotherapy

Outcomes

Primary Outcome Measures

Assess the effectiveness of combined therapy : omalizumab+ immunotherapy

Daily dose of inhaled steroids (changes)

Secondary Outcome Measures

Full Information

NCT ID

NCT06027073

First Posted

August 30, 2023

Last Updated

August 30, 2023

Sponsor

Medical University of Silesia

Collaborators

Centrum Medyczne Andrzej Bożek

1. Study Identification

Unique Protocol Identification Number

NCT06027073

Brief Title

Biologics and Sublingual Immunotherapy

Acronym

BSIPL

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 1, 2024 (Anticipated)

Primary Completion Date

October 1, 2026 (Anticipated)

Study Completion Date

March 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of Silesia

Collaborators

Centrum Medyczne Andrzej Bożek

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma, Allergic

Keywords

IgE, asthma, omalizumab, immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

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).

Masking

None (Open Label)

Allocation

Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

omalizumab

Arm Type

Active Comparator

Arm Description

standard antiasthmatic therapy and omalizumab

Arm Title

oral tablet HDM-immunotherapy

Arm Type

Active Comparator

Arm Description

standard antiasthmatic therapy and oral immunotherapy

Arm Title

combi therapy

Arm Type

Active Comparator

Arm Description

standard antiasthmatic therapy and omalizumab, and oral immunotherapy

Arm Title

control

Arm Type

No Intervention

Intervention Type

Biological

Intervention Name(s)

omalizumab

Intervention Description

adding omalizumab to anti asthmatic therapy

Primary Outcome Measure Information:

Title

Assess the effectiveness of combined therapy : omalizumab+ immunotherapy

Description

Daily dose of inhaled steroids (changes)

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Andrzej Bozek, prof

Phone

0048608318547

andrzejbozek@o2.pl

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

by computer database registration

Learn more about this trial

Biologics and Sublingual Immunotherapy

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