Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04272463
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment
Severe Asthma Other: No intervention

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: ChAracterisation of ItaliaN Severe Uncontrolled Asthmatic patieNts Key Features When Receiving Benralizumab in a Real Life Setting: an Observational rEtrospective Study
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma


Intervention Details:
  • Other: No intervention
    Patients currently in treatment with benralizumab as per approved indication and clinical practice


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04272463


Contacts
Layout table for location contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
Layout table for location information
Italy
Research Site Recruiting
Ostuni, Italy, 72017
Sponsors and Collaborators
AstraZeneca
Investigators
Layout table for investigator information
Principal Investigator: 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 Ospedale di Treviso
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
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04272463    
Other Study ID Numbers: D3250R00073
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases