ChAracterisation of ItaliaN Severe Uncontrolled Asthmatic patieNts Key Features When Receiving Benralizumab

NCT ID: NCT04272463

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 217 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-13
• Study Completion Date: 2020-07-15

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.

Conditions

Severe Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

No intervention

Patients currently in treatment with benralizumab as per approved indication and clinical practice

Intervention Type: OTHER

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Girolamo Pelaia, MD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi Magna Graecia

Pietro Bracciale, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale di Ostuni

Francesco Menzella, MD

Role: PRINCIPAL_INVESTIGATOR

Arcispedale Santa Maria Nuova, Reggio Emilia

Giorgio W Canonica, MD

Role: PRINCIPAL_INVESTIGATOR

Humanitas University Rozzano

Andrea Matucci, MD

Role: PRINCIPAL_INVESTIGATOR

AO Careggi Firenze

Mariella D'Amato, MD

Role: PRINCIPAL_INVESTIGATOR

AO Dei Colli Monaldi Napoli

Elisabetta Romagnoli, MD

Role: PRINCIPAL_INVESTIGATOR

Treviso Regional Hospital

Fausto De Michele, MD

Role: PRINCIPAL_INVESTIGATOR

AO Cardarelli Napoli

Paolo Palange, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico Umberto I Roma

Adriano Vaghi, MD

Role: PRINCIPAL_INVESTIGATOR

AO Garbagnate Milanese

Pietro Schino, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Miulli, Acquaviva delle Fonti

Paola Rogliani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rome Tor Vergata

Elena Bargagli, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico Le Scotte Siena

Stefano Centanni, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale San Paolo Milano

Cristiano Caruso, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Fondazione Gemelli Roma

Stefano Del Giacco, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Monserrato Cagliari

Maria Aliani, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Maugeri Cassano delle Murge

Diego Bagnasco, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS San Martino Genova

Antonino Musarra, MD

Role: PRINCIPAL_INVESTIGATOR

Casa della Salute Scilla

Fabiano Di Marco, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Papa Giovanni XXIII Bergamo

Gianenrico Senna, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Borgo Trento - Verona

Luigi Macchia, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico Bari

Locations

Research Site

Acquaviva delle Fonti, , Italy

Research Site

Bergamo, , Italy

Research Site

Cassano Murge, , Italy

Research Site

Catanzaro, , Italy

Research Site

Florence, , Italy

Research Site

Foggia, , Italy

Research Site

Garbagnate Milanese, , Italy

Research Site

Milan, , Italy

Research Site

Monserrato, , Italy

Research Site

Napoli, , Italy

Research Site

Ostuni, , Italy

Research Site

Reggio Emilia, , Italy

Research Site

Roma, , Italy

Research Site

Rozzano, , Italy

Research Site

Siena, , Italy

Research Site

Torino, , Italy

Research Site

Treviso, , Italy

Research Site

Verona, , Italy

Countries

Italy

References

Canonica GW, Consani L, Malerba L, Pelaia G, Vultaggio A; ANANKE investigators. Effects of benralizumab in patients with severe eosinophilic asthma (SEA): A plain language summary of the ANANKE study. Immunotherapy. 2024;16(14-15):913-923. doi: 10.1080/1750743X.2024.2386899. Epub 2024 Sep 17.

Reference Type: DERIVED

PMID: 39287158 (View on PubMed)

Vultaggio A, Aliani M, Altieri E, Bracciale P, Brussino L, Caiaffa MF, Cameli P, Canonica GW, Caruso C, Centanni S, D'Amato M, De Michele F, Del Giacco S, Di Marco F, Menzella F, Pelaia G, Rogliani P, Romagnoli M, Schino P, Senna G, Benci M, Boarino S, Schroeder JW. Long-term effectiveness of benralizumab in severe eosinophilic asthma patients treated for 96-weeks: data from the ANANKE study. Respir Res. 2023 May 20;24(1):135. doi: 10.1186/s12931-023-02439-w.

Reference Type: DERIVED

PMID: 37210543 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35183167 (View on PubMed)

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D3250R00073&attachmentIdentifier=9c02d35c-2d0a-4a54-bc58-69278ad0a975&fileName=D3250R00073_CSR_Synopsis.pdf&versionIdentifier=

CSR Synopsis

Other Identifiers

D3250R00073

Identifier Type: -

Identifier Source: org_study_id