Severe AsthmaANANKENCT04272463

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

An observational study of Severe Asthma, run by AstraZeneca at 18 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Severe Asthma
How many people: 217 participants
Where: 18 sitesItaly
Study dates: 13 Mar 2020to 15 Jul 2020
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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").

Who cannot join

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.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

Italy18 sites

Research Site
Acquaviva delle Fonti
Research Site
Bergamo
Research Site
Cassano Murge
Research Site
Catanzaro
Research Site
Florence
Research Site
Foggia
Research Site
Garbagnate Milanese
Research Site
Milan
Research Site
Monserrato
Research Site
Naples
Research Site
Ostuni
Research Site
Reggio Emilia
Research Site
Roma
Research Site
Rozzano
Research Site
Siena
Research Site
Torino
Research Site
Treviso
Research Site
Verona

Other trials in Italy

About this study

Official title: ChAracterisation of ItaliaN Severe Uncontrolled Asthmatic patieNts Key Features When Receiving Benralizumab in a Real Life Setting: an Observational rEtrospective Study

Read the 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
Being tested: No intervention
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No interventionOther
Patients currently in treatment with benralizumab as per approved indication and clinical practice

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At baseline

Secondary outcomes (9)

severe exacerbations during benralizumab treatment
Proportion of patients experiencing at least 1 severe exacerbation during benralizumab treatment.
Severe exacerbation incidence rate during benralizumab treatment, calculated as the number of patients with at least one exacerbation occurred during benralizumab treatment (cases) divided by the person-time at risk considering the duration of observation while the patient was receiving benralizumab.
Annual severe exacerbation rate, which will be calculated as the ratio between the total number of severe exacerbations occurred in the sample and the total number of person-years (i.e. the actual time-at-risk that all evaluable patients contributed to the study while they were in treatment with benralizumab).
Measured: at 16 weeks
ICS and OCS change during benralizumab treatment
ICS dose change of any extent Change of OCS dose (final dose* with respect to index date; if applicable)
Measured: at 16 weeks
IgE and eosinophils count during benralizumab treatment, and changes over time with respect to benralizumab treatment start
Descriptive statistics of total IgE and eosinophils count in peripheral blood as measured at the time points specified.
Descriptive statistics of intra-patient changes over time in total IgE and eosinophils count in peripheral blood, at each time points specified with respect to index date (according to data availability).
Measured: at 16 weeks
lung function parameters during benralizumab treatment, and changes over time with respect to benralizumab treatment start
Descriptive statistics of lung function parameters as measured at the time points specified.
Descriptive statistics of intra-patient changes over time in lung function parameters, at each time points specified with respect to index date (according to data availability).
Measured: 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
Descriptive statistics of Asthma Control Test (ACT) total score at index date (if available).
Descriptive statistics of ACT total score at the time points specified in chapter 4.2 (according to data availability), along with proportion of patients with well-controlled asthma (i.e. ACT score major of 20).
Descriptive statistics of intra-patient changes in ACT total score, at each time points specified in chapter 4.2 with respect to index date (according to data availability).
Descriptive statistics of Asthma Quality of Life Questionnaire (AQLQ) total score at index date (if available).
Descriptive statistics of AQLQ total score at the time points specified in chapter 4.2 (according to data availability).
Descriptive statistics of intra-patient changes in AQLQ total score, at each time points specified in chapter 4.2 with respect to index date (according to data availability).
Measured: at 16 weeks
patient's adherence to benralizumab treatment
Descriptive statistics of level of patient's adherence to benralizumab treatment, computed as the ratio (in percentage) between the number of actual injections received during the observation period over the number of expected injections (which will be estimated considering the injection schedulation specified in the SmPC).
Measured: at 16 weeks
healthcare resource utilization during benralizumab treatment
Descriptive statistics of total number (per patient) of the following healthcare resource utilization occurred during benralizumab treatment: GP/specialist visits for asthma, ER admissions for asthma, and hospitalizations for asthma.
Measured: at 16 weeks
benralizumab discontinuation
Proportion of patients with benralizumab permanent discontinuation during the observation period, and description of reasons.
Measured: at 16 weeks
biologic treatments during the observation period
Proportion of patients with subsequent biologic treatments for asthma, and description of type of treatment and reason for switch
Measured: at 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 202015 Jul 2020

First posted17 Feb 2020
Study start13 Mar 2020
Primary completion15 Jul 2020
Study completion15 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Severe AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 217 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04272463
Sponsor's protocol ID: D3250R00073
Acronym: ANANKE
Status last verified: Aug 2023
First submitted: 19 Jan 2020
Last updated: 31 Aug 2023
Results posted: No
Individual data sharing: No: No plan to share IPD

Publications

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.
PubMed 39287158
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.
PubMed 37210543
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.
PubMed 35183167

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Severe Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ChAracterisation of ItaliaN Severe Uncontrolled Asthmatic patieNts Key Features When Receiving Benralizumab in a Real Life Setting: an Observational rEtrospective Study
ClinicalTrials.gov ID: NCT04272463
Acronym / sponsor ID: ANANKE / D3250R00073
Conditions: Severe Asthma
Study type: Observational
Recruitment status: Completed
Enrolment: 217 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 13 Mar 2020 (actual)
Primary completion: 15 Jul 2020 (actual)
Study completion: 15 Jul 2020 (actual)
First posted: 17 Feb 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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

Key inclusion criteria (5 listed)

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").

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No interventionPatients currently in treatment with benralizumab as per approved indication and clinical practice	Other	–

Primary outcome

key features at benralizumab treatment start)
Time frame: At baseline
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.

9 secondary outcomes

severe exacerbations during benralizumab treatment
Time frame: at 16 weeks
ICS and OCS change during benralizumab treatment
Time frame: at 16 weeks
IgE and eosinophils count during benralizumab treatment, and changes over time with respect to benralizumab treatment start
Time frame: at 16 weeks
lung function parameters during benralizumab treatment, and changes over time with respect to benralizumab treatment start
Time frame: 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
Time frame: at 16 weeks
patient's adherence to benralizumab treatment
Time frame: at 16 weeks
healthcare resource utilization during benralizumab treatment
Time frame: at 16 weeks
benralizumab discontinuation
Time frame: at 16 weeks
biologic treatments during the observation period
Time frame: at 16 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
Derived from this study: PubMed 39287158Canonica 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.
Derived from this study: PubMed 37210543Vultaggio 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.
Derived from this study: PubMed 35183167Menzella 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.
CSR SynopsisLink provided by the sponsor.
Individual participant dataSharing planned: No. No plan to share IPD

Related trials for Severe Asthma

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RecruitingPhase 2
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RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig ( PF-07275315) in People With Severe Asthma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Girolamo Pelaia, MD principal investigator

Università degli Studi Magna Graecia

Pietro Bracciale, MD principal investigator

Ospedale di Ostuni

Francesco Menzella, MD principal investigator

Arcispedale Santa Maria Nuova, Reggio Emilia

18 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Severe Asthma, run by AstraZeneca at 18 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

key features at benralizumab treatment start) (time frame: At baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04272463, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.