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NCT Number: NCT04272463

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

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.

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Key information

Conditions

Severe Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Acquaviva delle Fonti, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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").

Exclusion criteria

  • 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.

Treatment and study plan

No intervention

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. severe exacerbations during benralizumab treatment

    Time frame: at 16 weeks

    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).

  2. ICS and OCS change during benralizumab treatment

    Time frame: at 16 weeks

    ICS dose change of any extent Change of OCS dose (final dose* with respect to index date; if applicable)

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

    Time frame: at 16 weeks

    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).

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

    Time frame: at 16 weeks

    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).

  5. 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

    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).

  6. patient's adherence to benralizumab treatment

    Time frame: at 16 weeks

    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).

  7. healthcare resource utilization during benralizumab treatment

    Time frame: at 16 weeks

    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.

  8. benralizumab discontinuation

    Time frame: at 16 weeks

    Proportion of patients with benralizumab permanent discontinuation during the observation period, and description of reasons.

  9. biologic treatments during the observation period

    Time frame: at 16 weeks

    Proportion of patients with subsequent biologic treatments for asthma, and description of type of treatment and reason for switch

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: ANANKE

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 17, 2020
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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