Biologics and Sublingual Immunotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2028-03-01

Brief Summary

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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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Detailed Description

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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

Conditions

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Asthma, Allergic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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omalizumab

standard antiasthmatic therapy and omalizumab

Group Type ACTIVE_COMPARATOR

omalizumab

Intervention Type BIOLOGICAL

adding omalizumab to anti asthmatic therapy

oral tablet HDM-immunotherapy

standard antiasthmatic therapy and oral immunotherapy

Group Type ACTIVE_COMPARATOR

omalizumab

Intervention Type BIOLOGICAL

adding omalizumab to anti asthmatic therapy

combi therapy

standard antiasthmatic therapy and omalizumab, and oral immunotherapy

Group Type ACTIVE_COMPARATOR

omalizumab

Intervention Type BIOLOGICAL

adding omalizumab to anti asthmatic therapy

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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omalizumab

adding omalizumab to anti asthmatic therapy

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No