NCT06288516CompletedPhase 4
BenRalizumab Effect on Airway Remodeling in Severe asTHma
BenRalizumab Effect on Airway Remodeling in Severe Eosinophilic asTHmatics
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
Response to biologic therapies in severe asthma is variable, with patients being either non-responders, responders or super-responders. There is currently no explanation for this broad variation in response. It is important to examine whether these patients have distinct characteristics that could help the treating physician in making the correct diagnosis in clinical practice. Aim of this clinical study is to evaluate the efficacy of benralizumab, a humanized an anti-interleukin 5 receptor α monoclonal antibody in patients with severe eosinophilic asthma and to evaluate airway remodeling before and after benralizumab treatment. Hypothesis Identification of pathological and clinical characteristics in patients with severe eosinophilic asthma after benralizumab treatment regarding the airway remodeling, inflammatory cells, and other biomarkers on a long-term basis. Research questions Is there any improvement in airway remodeling? Are there any biomarkers to predict response to benralizumab treatment in severe eosinophilic asthmatic patients?
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 25 Feb 2024
- Start date
- 1 Mar 2024
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Aristotle University Of Thessaloniki
- Diseases
- Asthma
- NCT number
- NCT06288516
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 36
- From 1 Mar 2024 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Asthma exacerbation, within 6 weeks prior to screening that required hospitalization or emergency room visit.
- Prior use of other biologics that has potential to interfere/ affect disease progression.
Other illness
- History of malignancy of any organ system or any other serious co-morbidities defined by the treating physician.
- Patients with a history of conditions other than asthma that could result in elevated eosinophils (e.g. hypereosinophilic syndromes, Churg-Strauss Syndrome, eosinophilic esophagitis).
Other
- Pregnant or nursing women, or women of child-bearing potential.
Who the study is looking for
- Written informed consent must be obtained at screening visit, before any assessment will be performed. Subjects should be able to provide informed written consent (study participation informed consent form): Able to give written informed consent prior to participation in the study, which will include the ability to comply with the requirements and restrictions listed in the consent form. Subjects must be able to read, comprehend, and write at a level sufficient to complete study related materials.
- Confirmed severe asthma diagnosis and treatment requirements according to American Thoracic Society(ATS)/European Respiratory Society (ERS) guidelines and Global Initiative for Asthma (GINA) 2023.
- Blood eosinophils ≥150cells/ul at screening visit or ≥300cells/ul the last 12 months.
- Patients with history ≥ 1 exacerbation the previous year under the treatment of high dose of inhaled corticosteroid(ICS)+LABA±LAMA or receiving oral/systemic corticosteroids at least 3 days. For subjects on maintenance oral corticosteroids, an exacerbation requiring oral corticosteroids was defined as the use of oral/systemic corticosteroids at least double the existing dose for at least 3 days.
- Meet requirements for biologic therapy with Benralizumab.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pulmonary Clinic, Aristotle University of Thessaloniki, George Papanikolaou Hospital Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.