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NCT06288516: BREATH
BenRalizumab Effect on Airway Remodeling in Severe asTHma
Phase 4 trial testing Benralizumab 30 mg/ml in Asthma; Eosinophilic in 45 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Aristotle University Of Thessaloniki |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 45 |
| Start date | 1 March 2024 |
| Primary completion | 31 December 2025 |
| Estimated completion | 1 June 2026 |
| Sites | 1 location across Greece |
Drugs / interventions tested
- Benralizumab 30 mg/ml — full drug profile →
Conditions studied
- Asthma; Eosinophilic — all drugs for Asthma; Eosinophilic →
- Airway Remodeling — all drugs for Airway Remodeling →
Sponsor
Aristotle University Of Thessaloniki
Who can join
Adults 18 to 85, any sex, with Asthma; Eosinophilic or Airway Remodeling. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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?
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Biologics and airway remodeling in asthma: early, late, and potential preventive effects.
Varricchi G, Poto R, Lommatzsch M, Brusselle G, et al · · 2025 · cited 33× · PMID 39520155 · DOI 10.1111/all.16382
Verify or expand the search:
- PubMed search for NCT06288516
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Asthma; Eosinophilic
Currently open trials in the same condition.
- NCT06488755 — SIM0718 Treatment of Asthma Clinical Study · Phase 3 · recruiting
- NCT05942222 — A Real-world, Head-to-head Comparison of Dupilumab Versus Mepolizumab in Danish Patients With Chronic Rhinosinusitis Wit · Phase 4 · active not recruiting
- NCT05404763 — Mepolizumab and Physical Activity in Severe Asthma · recruiting
- NCT05144087 — The Influence of Mepolizumab on Structural and Inflammatory Cells in Severe Eosinophilic Asthma · active not recruiting
Other Aristotle University Of Thessaloniki trials
Trials by the same sponsor.
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- NCT07297121 — Validation of the Montreal Cognitive Assessment (MoCA) Version 8.x and MoCA-MIS in Greece. · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06288516 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Aristotle University Of Thessaloniki
- Last refreshed: 4 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06288516.
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