A Real-life Observational Study in Severe Eosinophilic Asthma Adult Participant Treated With Benralizumab sc Injection in Italy
- Conditions
- Severe Eosinophilic Asthma
- Registration Number
- NCT07214753
- Lead Sponsor
- AstraZeneca
- Brief Summary
This is an observational, multicenter, prospective study on patients with severe eosinophilic asthma treated with benralizumab aimed at evaluating the achievement of partial and complete clinical remission.
- Detailed Description
The ATHENA study aims to expand real-world evidence on benralizumab role in clinical practice, specifically evaluating its effectiveness in achieving clinical remission (complete and partial), as defined by SANI. Additionally, given the growing importance of biomarkers in asthma research, this study seeks to further investigate benralizumab immunological effects, potentially contributing to a deeper understanding of asthma pathophysiology and addressing existing knowledge conundrum. Additionally, the study will consolidate long-term safety data.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 335
- Adults (≥ 18 years old) diagnosed with severe uncontrolled eosinophilic asthma.
- Benralizumab has been prescribed according to the approved label and local reimbursement criteria
- Provision of signed Informed Consent Form (ICF) prior to any study-related activities
- Benralizumab has been initiated within 7 days prior to study enrollment or is planned to be initiated within 7 days after enrollment (in the latter case, provided that the decision to prescribe benralizumab is made prior to the decision to enroll the patient in the study).
- Benralizumab treatment within the 12 months prior to study enrollment and up to 8 days before enrollment
- Previous participation (in the 12 months before enrollment), current participation or plan to participate within the follow up period to any other clinical trial.
- Contraindication to benralizumab as per current Summary of Product Characteristics (SmPC).
- Pregnant or lactating women.
- patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on the Investigator's judgement.
- Previous or concomitant use of omalizumab, reslizumab, dupilumab, tezepelumab or mepolizumab without washout period as per clinical practice
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number and percentage of patients achieving clinical remission, partial and complete, as per SANI Definition 24 months Number and percentage of patient who met the 4 remission criteria (complete or partial) at 12 months and maintained up to 24months
- Secondary Outcome Measures
Name Time Method Number and percentage of patients achieving the criteria for clinical remission 3, 6, 12 and 24 months Number and percentage of patient with the criteria for complete or partial remission according to the following criteria: No need to use OCS; Absence of asthma symptoms (ACT score from 20/25 to 25/25); Absence of asthma exacerbations; Stable lung function (FEV1 decline of no more than 100 mL).
Rate of any and SA exacerbations 3, 6, 12 and 24 months annualized exacerbations rate
Mean change in ACT score 1, 3, 6, 12 and 24 months vs baseline mean (SD) changes overtime in ACT score
Mean changes in ACQ score 1, 3, 6, 12 and 24 months vs baseline mean (SD) changes overtime in ACQ score
Mean change in FEV1 - pre-BD 3, 6, 12 and 24 vs baseline mean (SD) changes in FEV1 (L) overtime
Mean changes in FEV1 - post-BD 3, 6, 12 and 24 months vs baseline mean (SD) changes in FEV1 (L) post-BD
Mean changes in FEV1 % predicted - pre-BD 3, 6, 12 and 24 months vs baseline mean (SD) changes in FEV1 % predicted pre-BD
Mean changes in FEV1 % predicted - post-BD 3, 6, 12 and 24 months vs baseline mean (SD) changes in FEV1 % predicted post-BD
Mean changes in FVC pre-BD 3, 6, 12 and 24 months vs baseline mean (SD) changes in FVC (L) pre-BD
Mean changes in FVC post-BD 3, 6, 12 and 24 months vs baseline mean (SD) changes in FVC (L) post-BD
Mean changes in pre-BD FEV1/FVC 3, 6, 12 and 24 months vs baseline mean (SD) changes in pre-BD FEV1/FVC (ratio)
Mean changes in pre-BD FEF 25-75 3, 6, 12 and 24 months vs baseline mean (SD) changes in pre\_BD FEF25-75 (L/sec)
Mean changes in post-BD FEF 25-75 3, 6, 12 and 24 months vs baseline mean (SD) changes in post-BD FEF25-75 (L/sec)
Mean changes in post-BD FEV1/FVC 3, 6, 12 and 24 months vs baseline mean (SD) changes in post-BD FEV1/FVC (ratio)
Change in inhaled maintenance therapy and inhaled corticosteroid (ICS/LABA/LAMA, ICS/LABA) use and dosage 3, 6, 12 and 24 months Change in inhaled maintenance therapy and inhaled corticosteroid (ICS/LABA/LAMA, ICS/LABA) use and dosage after benralizumab treatment
Change in mOCS use and daily dose 3, 6, 12 and 24 months Change in mOCS use and daily dose after benralizumab administartion
Trial Locations
- Locations (28)
AZIENDA ULSS 6 EUGANEA_OSPEDALE DI CITTADELLA U.O.C. di Pneumologia
🇮🇹Cittadella, Padova, Italy
PRESIDIO OSPEDALIERO SANTA MARIA DELLA SPERANZA U.O.C. Medicina Interna
🇮🇹Battipaglia, Salerno, Italy
OSPEDALE MARIA S.S. DELLO SPLENDORE U.O.S.D. Allergologia Territoriale presidio ospedaliero Giulianova
🇮🇹Giulianova, Teramo, Italy
AULSS2 MARCA TREVIGIANA OSPEDALE CIVILE DI MONTEBELLUNA U.O.C. di Pneumologia
🇮🇹Montebelluna, Treviso, Italy
IRCCS MAUGERI TRADATE U.O.di Pneumologia Riabilitativa
🇮🇹Tradate, Varese, Italy
POLICLINICO DI BARI U.O.C. Malattie dell'Apparato Respiratorio
🇮🇹Bari, Italy
ASST PAPA GIOVANNI XXIII U.O.C. Pneumologia
🇮🇹Bergamo, Italy
IRCSS AZIENDA OSPEDALIERO UNIVERSITARIA DI BOLOGNA, POLICLINICO SANT'ORSOLA MALPIGHI U.O. Pneumologia e Terapia intensiva respiratoria
🇮🇹Bologna, Italy
OSPEDALE BELLARIA U.O.C. Pneumologia
🇮🇹Bologna, Italy
ASST SPEDALI CIVILI DI BRESCIA S.S.D. Centro Fibrosi Cistica
🇮🇹Brescia, Italy
Scroll for more (18 remaining)AZIENDA ULSS 6 EUGANEA_OSPEDALE DI CITTADELLA U.O.C. di Pneumologia🇮🇹Cittadella, Padova, Italy