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

NCT04272463 | Completed

• 1 other identifier: D3250R00073
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 18

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.

Conditions

Severe Asthma

Outcome Measures

Primary Outcomes (1)

• key features at benralizumab treatment start)

  Total IgE and eosinophils count in peripheral blood as measured at index date Lung function assessments Presence of comorbidities Previous severe exacerbations in the 12 months before index date. Previous treatments with biologics for asthma before index date. Maintenance asthma treatment(s) ongoing at index date.

  At baseline

Secondary Outcomes (9)

• severe exacerbations during benralizumab treatment

  at 16 weeks

• ICS and OCS change during benralizumab treatment

  at 16 weeks

• IgE and eosinophils count during benralizumab treatment, and changes over time with respect to benralizumab treatment start

  at 16 weeks

• lung function parameters during benralizumab treatment, and changes over time with respect to benralizumab treatment start

  at 16 weeks

• 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

  at 16 weeks

Interventions

No intervention OTHER

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Adult patients (age ≥18 years) at the start of benralizumab treatment within the sampling program or per clinical practice ("index date").
• 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).
• 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.
• Patients who signed the informed consent and privacy form at enrollment visit.
• Patients with available hospital medical chart since the start of benralizumab treatment within the sampling program or per clinical practice ("index date").

You may not qualify if:

• Patients who, during the observation period, received benralizumab in a clinical experimental trial.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (18)

Research Site

Acquaviva delle Fonti, Italy

Location

Research Site

Bergamo, Italy

Location

Research Site

Cassano Murge, Italy

Location

Research Site

Catanzaro, Italy

Location

Research Site

Florence, Italy

Location

Research Site

Foggia, Italy

Location

Research Site

Garbagnate Milanese, Italy

Location

Research Site

Milan, Italy

Location

Research Site

Monserrato, Italy

Location

Research Site

Napoli, Italy

Location

Research Site

Ostuni, Italy

Location

Research Site

Reggio Emilia, Italy

Location

Research Site

Roma, Italy

Location

Research Site

Rozzano, Italy

Location

Research Site

Siena, Italy

Location

Research Site

Torino, Italy

Location

Research Site

Treviso, Italy

Location

Research Site

Verona, Italy

Location

Related Publications (3)

• 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.

  PMID: 39287158 DERIVED

• 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.

  PMID: 37210543 DERIVED

• 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.

  PMID: 35183167 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Girolamo Pelaia, MD

  Università degli Studi Magna Graecia

  PRINCIPAL INVESTIGATOR

• Pietro Bracciale, MD

  Ospedale di Ostuni

  PRINCIPAL INVESTIGATOR

• Francesco Menzella, MD

  Arcispedale Santa Maria Nuova, Reggio Emilia

  PRINCIPAL INVESTIGATOR

• Giorgio W Canonica, MD

  Humanitas University Rozzano

  PRINCIPAL INVESTIGATOR

• Andrea Matucci, MD

  AO Careggi Firenze

  PRINCIPAL INVESTIGATOR

• Mariella D'Amato, MD

  AO Dei Colli Monaldi Napoli

  PRINCIPAL INVESTIGATOR

• Elisabetta Romagnoli, MD

  Treviso Regional Hospital

  PRINCIPAL INVESTIGATOR

• Fausto De Michele, MD

  AO Cardarelli Napoli

  PRINCIPAL INVESTIGATOR

• Paolo Palange, MD

  Policlinico Umberto I Roma

  PRINCIPAL INVESTIGATOR

• Adriano Vaghi, MD

  AO Garbagnate Milanese

  PRINCIPAL INVESTIGATOR

• Pietro Schino, MD

  Ospedale Miulli, Acquaviva delle Fonti

  PRINCIPAL INVESTIGATOR

• Paola Rogliani, MD

  University of Rome Tor Vergata

  PRINCIPAL INVESTIGATOR

• Elena Bargagli, MD

  Policlinico Le Scotte Siena

  PRINCIPAL INVESTIGATOR

• Stefano Centanni, MD

  Ospedale San Paolo Milano

  PRINCIPAL INVESTIGATOR

• Cristiano Caruso, MD

  IRCCS Fondazione Gemelli Roma

  PRINCIPAL INVESTIGATOR

• Stefano Del Giacco, MD

  Ospedale Monserrato Cagliari

  PRINCIPAL INVESTIGATOR

• Maria Aliani, MD

  IRCCS Maugeri Cassano delle Murge

  PRINCIPAL INVESTIGATOR

• Diego Bagnasco, MD

  IRCCS San Martino Genova

  PRINCIPAL INVESTIGATOR

• Antonino Musarra, MD

  Casa della Salute Scilla

  PRINCIPAL INVESTIGATOR

• Fabiano Di Marco, MD

  Ospedale Papa Giovanni XXIII Bergamo

  PRINCIPAL INVESTIGATOR

• Gianenrico Senna, MD

  Ospedale Borgo Trento - Verona

  PRINCIPAL INVESTIGATOR

• Luigi Macchia, MD

  Policlinico Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2020
• First Posted: February 17, 2020
• Study Start: March 13, 2020
• Primary Completion: July 15, 2020
• Study Completion: July 15, 2020
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (18)