Clinical trial NCT03907137: Real World Study With Benralizumab in Severe Asthma in Switzerland
Official title: Utilisation of Benralizumab in the Clinical Practise in Severe Eosinophilic Asthma Patients in Switzerland
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Eosinophilic Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-04-08
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will recruit 77 male and female patients aged ≥ 18 years with severe, eosinophilic asthma who meet all inclusion criteria and none of the exclusion criteria. Approximately 15-20 specialist centres across Switzerland will participate in the study which have experience with biologic treatment, can initiate treatment with benralizumab and have a good oversight on the severe asthma population, as in some settings the patients are referred for longer term stationary care to achieve asthma control.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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:

1. Male or female patients older than 18 years with physician's confirmed diagnosis of severe, uncontrolled asthma according to ATS/ERS guidelines.
2. Asthma requiring high-dose ICS plus LABA as maintenance treatment.
3. Minimum of 2 exacerbations in the last 12 months.
4. Documented peripheral blood eosinophil count ≥ 300 cells/μL blood.
5. 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.
6. 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:

1. Documented lung diseases other than asthma, e.g. COPD, and not within reimbursed label, e.g pregnancy or lactation.
2. 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.
3. 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.

Primary outcomes:
measure: Change from baseline ACQ-5 score after 8 weeks after initiation of benralizumab
timeFrame: 8 weeks
Secondary outcomes:
measure: Percentage of patients on OCS who were able to reduce their OCS after 16 weeks.
timeFrame: 16, 56 weeks
measure: Change from baseline in ACQ 5 score up to 16 weeks after initiation of treatment with benralizumab.
timeFrame: 1, 2, 4, 16, 56 weeks
measure: Proportion of patients with a total score improvement of ≥ 0.5 in ACQ-5 under treatment with benralizumab.
timeFrame: 1,2,4,8,16,56 weeks
measure: Change from baseline in PGI-C in asthma.
timeFrame: 1, 2, 4, 8, 16, 56 weeks
measure: Change from baseline in PGI-S in asthma
timeFrame: 1, 2, 4, 8, 16, 56 weeks
measure: Asthma disease history
timeFrame: Baseline
measure: Past treatment status
timeFrame: Baseline
measure: Patient demographics
timeFrame: Baseline
Other outcomes:
measure: Changes in PEF under treatment with benralizumab
timeFrame: 1, 2, 4, 8, 16, 56 weeks
measure: Outcome deterioration of asthma status (CompEx) with an electronic diary (app on smartphone) filled out by the patient.
timeFrame: Twice Daily throughout the study duration (16 weeks)
measure: Pre- and postbronchodilator changes in FEV1 under treatment with benralizumab.
timeFrame: 0, 8, 16, 56 weeks
measure: Pre- and postbronchodilator changes in FVC under treatment with benralizumab
timeFrame: 0, 8, 16, 56 weeks
measure: Change in OCS medication (median change in mg)
timeFrame: 4, 8, 16, 56 weeks
measure: Percentage of patients with OCS reduction
timeFrame: 4, 8, 16, 56 weeks
measure: Change of nasal polyposis relevant health status (taste and smell)
timeFrame: 1, 2, 4, 8, 16, 56 weeks
Locations:
city: Aathal
country: Switzerland
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Chur
country: Switzerland
facility: Research Site
city: Geneva
country: Switzerland
facility: Research Site
city: Liestal
country: Switzerland
facility: Research Site
city: Luzern
country: Switzerland
facility: Research Site
city: Sion
country: Switzerland
facility: Research Site
city: Wetzikon
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
Study officials:
affiliation: Kantonsspital Graubünden
name: Thomas Rothe, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: