Biologics and Sublingual Immunotherapy (BSIPL)

August 30, 2023 updated by: Medical University of Silesia

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the effectiveness of combined therapy : omalizumab+ immunotherapy
Time Frame: 3 years
Daily dose of inhaled steroids (changes)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Collaborators

Centrum Medyczne Andrzej Bożek

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

August 30, 2023

First Submitted That Met QC Criteria

August 30, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM-01966

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

by computer database registration

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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