Asthma, AllergicPhase 4BSIPLNCT06027073
Biologics and Sublingual Immunotherapy
A Phase 4 study testing omalizumab in people with Asthma, Allergic, run by Medical University of Silesia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma, Allergic
- What is being tested?
- omalizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Conditions
- Asthma, Allergic
- Being tested
- omalizumab
- Keywords
- IgE, asthma, omalizumab, immunotherapy
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omalizumabBiological
adding omalizumab to anti asthmatic therapy
| Study group | Role | What they receive |
|---|---|---|
| omalizumab | Active comparator | standard antiasthmatic therapy and omalizumab Receives: Biological: omalizumab |
| oral tablet HDM-immunotherapy | Active comparator | standard antiasthmatic therapy and oral immunotherapy Receives: Biological: omalizumab |
| combi therapy | Active comparator | standard antiasthmatic therapy and omalizumab, and oral immunotherapy Receives: Biological: omalizumab |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the effectiveness of combined therapy : omalizumab+ immunotherapy
Daily dose of inhaled steroids (changes)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 May 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma, AllergicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Collaborators
- Centrum Medyczne Andrzej Bożek
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027073
- Sponsor's protocol ID
- CM-01966
- Acronym
- BSIPL
- Status last verified
- Aug 2023
- First submitted
- 30 Aug 2023
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: by computer database registration
Publications
Batard T, Taille C, Guilleminault L, Bozek A, Floch VB, Pfaar O, Canonica WG, Akdis C, Shamji MH, Mascarell L. Allergen Immunotherapy for the Prevention and Treatment of Asthma. Clin Exp Allergy. 2025 Feb;55(2):111-141. doi: 10.1111/cea.14575. Epub 2024 Oct 4.
PubMed 39363801
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Biological Therapy to Asthmatic Patients on Allergen Immunotherapy to House Dust Mites
- ClinicalTrials.gov ID
- NCT06027073
- Acronym / sponsor ID
- BSIPL / CM-01966
- Conditions
- Asthma, Allergic
- Keywords
- IgE, asthma, omalizumab, immunotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Collaborators
- Centrum Medyczne Andrzej Bożek
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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).
| Arm | Type | Receives |
|---|---|---|
| omalizumab | Active comparator | Biological: omalizumabstandard antiasthmatic therapy and omalizumab |
| oral tablet HDM-immunotherapy | Active comparator | Biological: omalizumabstandard antiasthmatic therapy and oral immunotherapy |
| combi therapy | Active comparator | Biological: omalizumabstandard antiasthmatic therapy and omalizumab, and oral immunotherapy |
| control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omalizumabadding omalizumab to anti asthmatic therapy | Biological | combi therapy, omalizumab, oral tablet HDM-immunotherapy |
Primary outcome
Assess the effectiveness of combined therapy : omalizumab+ immunotherapy
Time frame: 3 years
Daily dose of inhaled steroids (changes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Derived from this study: PubMed 39363801Batard T, Taille C, Guilleminault L, Bozek A, Floch VB, Pfaar O, Canonica WG, Akdis C, Shamji MH, Mascarell L. Allergen Immunotherapy for the Prevention and Treatment of Asthma. Clin Exp Allergy. 2025 Feb;55(2):111-141. doi: 10.1111/cea.14575. Epub 2024 Oct 4.
- Individual participant dataSharing planned: No. by computer database registration
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing omalizumab in people with Asthma, Allergic, run by Medical University of Silesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrzej Bozek, prof (0048608318547, andrzejbozek@o2.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the effectiveness of combined therapy : omalizumab+ immunotherapy (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06027073, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.