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Completed

NCT Number: NCT03907137

Real World Study With Benralizumab in Severe Asthma in Switzerland

BEEPS describes the utility of patient reported outcomes (PRO) as simple, pragmatic, and sensitive tool to assess early treatment response of benralizumab to document the level of asthma control and change in medication after 1 to 16 weeks post-treatment initiation including use of OCS. The generated data on the time of asthma symptom relief after initiation of benralizumab will support patient management for a better disease control in severe asthma patients under benralizumab treatment. To assess long term outcomes the patients will have a last mandatory visit after 56 weeks, with no visits scheduled between week 16 and 56.

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Key information

Conditions

Severe Eosinophilic Asthma Eosinophilia Hematologic Diseases Hemic and Lymphatic Diseases Hypereosinophilic Syndrome Leukocyte Disorders Lung Diseases Pulmonary Eosinophilia Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aathal, Switzerland

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About this study

The aim and objective of this single arm, prospective observational study is to describe patient reported outcomes (PRO) in severe eosinophilic asthma patients who are treated with benralizumab according to the label granted in Switzerland. The PRO measures consist of the weekly Asthma Control Questionnaire (ACQ-5) as well as Patient Global Impression of Change and Severity (PGI-C and PGI-S) collected at each visit (0, 1, 2, 4, 8, 16, 56 weeks). In addition the patient fills out twice daily the patient electronic asthma diary (eDiary) capturing daily symptoms and symptom free days together with a PEF (Peak Expiratory Flow) measurement. Persistance with eDiary and PEF will be assessed after 56 weeks. The percentage of patients successfully reducing their OCS dose will be evaluated after 16 weeks of treatment with benralizumab and if OCS reduction is persistent until week 56. Furthermore, the proportion of patients with an ACQ-5 score improvement of ≥ 0.5 after 8 weeks of treatment with benralizumab will be determined. In addition, the study will assess changes in FEV1 and FVC after 8, 16 and 56 weeks of treatment with benralizumab and describe retrospectively asthma disease history, past treatment status and current medication at baseline.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Subject eligible for enrolment in the study and treatment for benralizumab according to the specific Swiss label must meet all the following criteria:

  • Male or female patients older than 18 years with physician's confirmed diagnosis of severe, uncontrolled asthma according to ATS/ERS guidelines.
  • Asthma requiring high-dose ICS plus LABA as maintenance treatment.
  • Minimum of 2 exacerbations in the last 12 months.
  • Documented peripheral blood eosinophil count ≥ 300 cells/μL blood.
  • Provision of signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation in the study.
  • Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the questionnaires required by the protocol (ACQ-5, PGI-C and PGI-S).

Exclusion criteria

Subjects meeting any of the following criteria will not be eligible to participate in the study:

  • Documented lung diseases other than asthma, e.g. COPD, and not within reimbursed label, e.g pregnancy or lactation.
  • Currently enrolled in an interventional clinical study in parallel, except:
  • Patients being in parallel documented in a national asthma registry.
  • Patients having completed any other clinical trial including those with biologic treatment.
  • An acute or chronic condition that, in the investigator's opinion, would limit the patients' ability to complete questionnaires or participate in this study or impact the interpretations of results.

Treatment and study plan

Primary outcomes

  1. Change from baseline ACQ-5 score after 8 weeks after initiation of benralizumab

    Time frame: 8 weeks

    The ACQ-5 (Asthma Control Questionnaire - 5 questions) consists of 5 questions about the asthma symptoms in the last 7 days. Each question has a scale from 0 (no symptoms) to 6 (most severe). The reported mean score of all questions describes the level of asthma control (0-6) whereby a mean score >1,5 is considered as uncontrolled asthma.

Secondary outcomes

  1. Percentage of patients on OCS who were able to reduce their OCS after 16 weeks.

    Time frame: 16, 56 weeks

    In patients who take continuous oral corticosteroids (OCS) the fraction of patients who reduced the dosage of OCS is assessed. Daily oral OCS dosage in this patient group usually ranges from 2,5 to 40mg.

  2. Change from baseline in ACQ 5 score up to 16 weeks after initiation of treatment with benralizumab.

    Time frame: 1, 2, 4, 16, 56 weeks

    The ACQ-5 (Asthma Control Questionnaire - 5 questions) consists of 5 questions about the asthma symptoms in the last 7 days. Each question has a scale from 0 (no symptoms) to 6 (most severe). The reported mean score of all questions describes the level of asthma control (0-6) whereby a mean score >1,5 is considered as uncontrolled asthma.

  3. Proportion of patients with a total score improvement of ≥ 0.5 in ACQ-5 under treatment with benralizumab.

    Time frame: 1,2,4,8,16,56 weeks

    The ACQ-5 (Asthma Control Questionnaire - 5 questions) consists of 5 questions about the asthma symptoms in the last 7 days. Each question has a scale from 0 (no symptoms) to 6 (most severe). The reported mean score of all questions describes the level of asthma control (0-6) whereby a mean score >1,5 is considered as uncontrolled asthma.

  4. Change from baseline in PGI-C in asthma.

    Time frame: 1, 2, 4, 8, 16, 56 weeks

    The Patient Global Impression of Change (PGI-C) rates the patients general impression of his asthma health status since study start on a scale from 1 to 7. 1 meaning much better, 4 equal and 7 much worse.

  5. Change from baseline in PGI-S in asthma

    Time frame: 1, 2, 4, 8, 16, 56 weeks

    The Patient Global Impression of Severity (PGI-S) rates the current asthma status on a scale from 1 to 6. 1 meaning no symptoms and 6 meaning very heavy symptoms.

  6. Asthma disease history

    Time frame: Baseline

    The time and age of first asthma diagnosis, the presence of allergic cofactors and the history of exacerbations in the last 12 month since study start will be recorded.

  7. Past treatment status

    Time frame: Baseline

    Prescribed medication for Astma in the last 12 month before study enrollment will be recorded. Special emphasis will be put on inhallation therapy and OCS use and any changes. Any previous biological therapy will be recorded as well.

  8. Patient demographics

    Time frame: Baseline

    Age (Years), sex (m/f), weight (kg) and height (cm) will be recorded

Other outcomes

  1. Changes in PEF under treatment with benralizumab

    Time frame: 1, 2, 4, 8, 16, 56 weeks

    PEF=Peak Expiratory Flow; Measured in litres (l)

  2. Outcome deterioration of asthma status (CompEx) with an electronic diary (app on smartphone) filled out by the patient.

    Time frame: Twice Daily throughout the study duration (16 weeks)

    The morning diary comprises four questions, the evening diary comprises three questions assessing the current asthma status.

    The scores will be summarised to defie a Compex event which is defined as 2 of the following criteria for ≥ 2 consecutive days:

    • ≥15% decrease from baseline in morning or evening PEF

    And at least one of the following:

    • ≥1.5 puffs increase from baseline in rescue medication morning or evening
    • ≥1 score increase from baseline, or the absolute maximal asthma symptom score in the morning or evening.

    Or one of the criteria above together with all diary variable showing a slope of worsening over at least a 5-day period.

  3. Pre- and postbronchodilator changes in FEV1 under treatment with benralizumab.

    Time frame: 0, 8, 16, 56 weeks

    Forced Expiratory Volume in One Second (FEV1) is assessed by standard spirometry (measured in litres).

  4. Pre- and postbronchodilator changes in FVC under treatment with benralizumab

    Time frame: 0, 8, 16, 56 weeks

    Forced vital capacity will be assessed by standard routine spirometry (measured in liters).

  5. Change in OCS medication (median change in mg)

    Time frame: 4, 8, 16, 56 weeks

    Median OCS dose reduction

  6. Percentage of patients with OCS reduction

    Time frame: 4, 8, 16, 56 weeks

    Proportion of patients with a ≥25%, ≥50%, ≥75% and 100% OCS dose reduction Percentage of patients on OCS who were able to reduce their OCS dose

  7. Change of nasal polyposis relevant health status (taste and smell)

    Time frame: 1, 2, 4, 8, 16, 56 weeks

    For patients with nasal polyposis at baseline any improvement on taste/smell will be recorded categorically (yes/no)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Utilisation of Benralizumab in the Clinical Practise in Severe Eosinophilic Asthma Patients in Switzerland

Acronym: BEEPS

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2019
Registry last updated
Feb 29, 2024

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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