Clinical trial NCT04272463: ChAracterisation of ItaliaN Severe Uncontrolled Asthmatic patieNts Key Features When Receiving Benralizumab
Official title: ChAracterisation of ItaliaN Severe Uncontrolled Asthmatic patieNts Key Features When Receiving Benralizumab in a Real Life Setting: an Observational rEtrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2020-02-17
Enrollment: 217
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will enroll patients with severe eosinophilic asthma treated with benralizumab. Patients can be enrolled if they received benralizumab either within the sampling program or as per routine clinical practice.

Participating sites will enroll patients in a consecutive manner when patients come for their regular visit, in order to minimize the risk of selection bias.

A total of 200 patients are expected to be included in the study by around 20 sites, corresponding to approximately 10 patients/site: it is estimated that the study will enroll approximately 25 patients per month in the around 20 centers involved (approximately 1.3 patients/month/center). This target sample size is expected to be reached durin

Brief summary: This is an observational, Italian multi-center, retrospective cohort study with enrollment visit on patients suffering from severe eosinophilic asthma who started benralizumab in the Sampling Program or as per normal clinical practice in Italy.

Detailed description: A retrospective cohort study design involving secondary data collection was chosen to appropriately address the primary objective in a relatively short period of time after enrollment phase initiation: in fact, since the Italian Sampling Program on benralizumab was active since July 2018, clinical data on patients exposed to benralizumab are already available. No treatments will be administered per protocol requirement, but instead according to normal clinical practice; since benralizumab first administration occurs before inclusion in the study (as per chosen study design), the decision to include the patient in the study is clearly separated from the prescription of benralizumab, in accordance with the observational nature of the study. In order to be eligible for the study, for each patient, the index date shall be at least 3 months prior to enrollment.

Eligibility criteria: Inclusion Criteria:

1. Adult patients (age ≥18 years) at the start of benralizumab treatment within the sampling program or per clinical practice ("index date").
2. Patients with severe eosinophilic asthma requiring a stable treatment of high doses of inhaled corticosteroids and a long acting β2 agonist ± additional asthma controller (according to clinician's judgment).
3. Patients who started benralizumab and received at least one injection at least 3 months before enrollment, either within the sampling program or as per routine clinical practice.
4. Patients who signed the informed consent and privacy form at enrollment visit.
5. Patients with available hospital medical chart since the start of benralizumab treatment within the sampling program or per clinical practice ("index date").

Exclusion Criteria:

1. Patients who, during the observation period, received benralizumab in a clinical experimental trial.
2. Patients who, during the observation period, participated in studies imposing a specific patient's management strategy which does not correspond to the site's normal clinical practice.

Primary outcomes:
measure: key features at benralizumab treatment start)
timeFrame: At baseline
Secondary outcomes:
measure: severe exacerbations during benralizumab treatment
timeFrame: at 16 weeks
measure: ICS and OCS change during benralizumab treatment
timeFrame: at 16 weeks
measure: IgE and eosinophils count during benralizumab treatment, and changes over time with respect to benralizumab treatment start
timeFrame: at 16 weeks
measure: lung function parameters during benralizumab treatment, and changes over time with respect to benralizumab treatment start
timeFrame: at 16 weeks
measure: patients' asthma control level and quality of life at benralizumab treatment start, during the observation period, and changes over time with respect to benralizumab treatment start
timeFrame: at 16 weeks
measure: patient's adherence to benralizumab treatment
timeFrame: at 16 weeks
measure: healthcare resource utilization during benralizumab treatment
timeFrame: at 16 weeks
measure: benralizumab discontinuation
timeFrame: at 16 weeks
measure: biologic treatments during the observation period
timeFrame: at 16 weeks
Other outcomes:
Locations:
city: Acquaviva delle Fonti
country: Italy
facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
city: Cassano Murge
country: Italy
facility: Research Site
city: Catanzaro
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Foggia
country: Italy
facility: Research Site
city: Garbagnate Milanese
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Monserrato
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Ostuni
country: Italy
facility: Research Site
city: Reggio Emilia
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Rozzano
country: Italy
facility: Research Site
city: Siena
country: Italy
facility: Research Site
city: Torino
country: Italy
facility: Research Site
city: Treviso
country: Italy
facility: Research Site
city: Verona
country: Italy
facility: Research Site
Study officials:
affiliation: Università degli Studi Magna Graecia
name: Girolamo Pelaia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale di Ostuni
name: Pietro Bracciale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arcispedale Santa Maria Nuova, Reggio Emilia
name: Francesco Menzella, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Humanitas University Rozzano
name: Giorgio W Canonica, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AO Careggi Firenze
name: Andrea Matucci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AO Dei Colli Monaldi Napoli
name: Mariella D'Amato, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Treviso Regional Hospital
name: Elisabetta Romagnoli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AO Cardarelli Napoli
name: Fausto De Michele, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico Umberto I Roma
name: Paolo Palange, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AO Garbagnate Milanese
name: Adriano Vaghi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Miulli, Acquaviva delle Fonti
name: Pietro Schino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rome Tor Vergata
name: Paola Rogliani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico Le Scotte Siena
name: Elena Bargagli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale San Paolo Milano
name: Stefano Centanni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Fondazione Gemelli Roma
name: Cristiano Caruso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Monserrato Cagliari
name: Stefano Del Giacco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS Maugeri Cassano delle Murge
name: Maria Aliani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCCS San Martino Genova
name: Diego Bagnasco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Casa della Salute Scilla
name: Antonino Musarra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Papa Giovanni XXIII Bergamo
name: Fabiano Di Marco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Borgo Trento - Verona
name: Gianenrico Senna, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico Bari
name: Luigi Macchia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Menzella F, Bargagli E, Aliani M, Bracciale P, Brussino L, Caiaffa MF, Caruso C, Centanni S, D'Amato M, Del Giacco S, De Michele F, Di Marco F, Pastorello EA, Pelaia G, Rogliani P, Romagnoli M, Schino P, Senna G, Vultaggio A, Simoni L, Ori A, Boarino S, Vitiello G, Altieri E, Canonica GW. ChAracterization of ItaliaN severe uncontrolled Asthmatic patieNts Key features when receiving Benralizumab in a real-life setting: the observational rEtrospective ANANKE study. Respir Res. 2022 Feb 19;23(1):36. doi: 10.1186/s12931-022-01952-8.