Clinical trial NCT04184284: Change in Patient-Reported Outcomes in Severe Eosinophilic Asthma Patients Treated With Benralizumab Under Real-life Conditions
Official title: imPROve-asthma - A Prospective, 24-month, Observational Study to Investigate the Change in Patient-Reported Outcomes in Severe Eosinophilic Asthma Patients Treated With Benralizumab Biologic Therapy Under Real-life Conditions in Germany
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: benralizumab
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-12-03
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: approximately 350 to 500 patients in 70 pulmonology sites (hospitals and outpatient practices) in Germany Primary study cohort: approximately 250 patients Secondary study cohort: approximately 100 to 250 patients

Brief summary: The main aim of this study is to investigate the change in asthma control after 6 months of therapy in patients treated with benralizumab biologic therapy for severe eosinophilic asthma under real-life conditions in a pulmonary care setting in Germany. The study also aims to investigate Quality-of-Life (QoL), the early treatment response, treatment effectiveness and the change in asthma control over time, following benralizumab therapy. This study will also describe the physician-chosen reasons for starting beralizumab therapy or switching to benralizumab therapy.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged 18 years or older with confirmed diagnosis of severe asthma according to the ATS/ERS and local German guidelines
* Decision was made by the investigator (regardless of this NIS) to start treating the patient with benralizumab according to severe eosinophilic asthma indication (NB: can include patients that are switched from another EU approved biologic treatment if required for a medical reason).
* Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the questionnaires required by the protocol
* After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

* Concomitant treatment with any other biologic for any indication
* Patients already treated with benralizumab
* Clinically important pulmonary disease other than asthma including: chronic obstructive pulmonary disease (as main diagnosis), bronchiectasis, idiopathic pulmonary fibrosis, pulmonary hypertension, alpha-1-antitrypsin-deficiency, and malignancy of any kind (NB: the following conditions are permitted: nasal polyposis, allergic rhinitis, atopic dermatitis, non-idiopathic pulmonary fibrosis).
* An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to complete questionnaires or participate in this study or impact the interpretations of results.
* Concurrent biologics for asthma are not allowed except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment). Acceptable wash-out periods for other asthma biologics: ≥30 days from last dose of previous biologic
* Pregnancy or lactation period
* Participation in an observational trial that might, in the investigator's opinion, influence the assessment for the current study, or participation in a randomized clinical trial in the last 3 months

Primary outcomes:
measure: The change in asthma control after 6 months of treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment
timeFrame: Baseline and 6 months after baseline
Secondary outcomes:
measure: The investigator reported treatment effectiveness after 6 months of treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment
timeFrame: 6 months after first treatment
measure: The change in health-related quality of life (HRQL) in anti-IL5/IL5R naïve patients initiated with benralizumab treatment
timeFrame: Baseline and 6 months after first treatment
measure: The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 7, ACQ-6
timeFrame: Baseline and day 7 after first treatment
measure: The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 7, VAS-1
timeFrame: Baseline and day 7 after first treatment
measure: The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 7, VAS-2
timeFrame: Baseline and day 7 after first treatment
measure: The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 14, ACQ-6
timeFrame: Baseline and day 14 after first treatment
measure: The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 14, VAS-1
timeFrame: Baseline and day 14 after first treatment
measure: The early treatment response in anti-IL5/IL5R naïve patients initiated with benralizumab treatment, day 14, VAS-2
timeFrame: Baseline and day 14 after first treatment
measure: The change of asthma control over time and the maintained response after initiation of benralizumab treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment using ACT
timeFrame: Date of enrollment until end of follow-up (approx. 24 months after enrollment)
measure: The change of asthma control over time and the maintained response after initiation of benralizumab treatment in anti-IL5/IL5R naïve patients initiated with benralizumab treatment using ACQ-6
timeFrame: Date of enrollment until end of follow-up (approx. 24 months after enrollment)
measure: The reasons for biologic treatment change
timeFrame: Date of enrollment until end of follow-up (approx. 24 months after enrollment)
Other outcomes:
measure: The change of physical activity over time in anti-IL5/IL5R naïve patients
timeFrame: Baseline until end of follow-up (approx. 24 months after enrollment)
measure: The change in asthma control after 6, 12, 18 and 24 months of treatment in biologic experienced patients, using ACT
timeFrame: Baseline, 6, 12, 18 and 24 months after first treatment
measure: The change in asthma control and the maintained response after initiation of benralizumab treatment in biologic experienced patients using ACQ-6
timeFrame: Baseline, 6, 12, 18 and 24 months after first treatment
measure: The change in HRQL after 6, 12, 18 and 24 months of treatment in biologic experienced patients
timeFrame: Baseline, 6, 12, 18 and 24 months after first treatment
measure: The early treatment response in biologic experienced patients initiated with benralizumab treatment, ACQ-6
timeFrame: Baseline, day 7 and day 14 after first treatment
measure: The early treatment response in biologic experienced patients initiated with benralizumab treatment, patient satisfaction, VAS-1
timeFrame: Baseline, day 7 and day 14 after first treatment
measure: The early treatment response in biologic experienced patients initiated with benralizumab treatment, patient symptoms, VAS-2
timeFrame: Baseline, day 7 and day 14 after first treatment
measure: The investigator reported treatment effectiveness after 6 months of treatment in biologic experienced patients initiated with benralizumab treatment
timeFrame: 6 months after first treatment
Locations:
city: Aschaffenburg
country: Germany
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Bamberg
country: Germany
facility: Research Site
city: Beelitz
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Biberach
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Bremen
country: Germany
facility: Research Site
city: Cottbus
country: Germany
facility: Research Site
city: Darmstadt
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Duesseldorf
country: Germany
facility: Research Site
city: Dusseldorf
country: Germany
facility: Research Site
city: Flensburg
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Fuerstenwalde
country: Germany
facility: Research Site
city: Furstenwalde
country: Germany
facility: Research Site
city: Gelsenkirchen
country: Germany
facility: Research Site
city: Gerlingen
country: Germany
facility: Research Site
city: Gotingen
country: Germany
facility: Research Site
city: Halberstadt
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Hemer
country: Germany
facility: Research Site
city: Hettstedt
country: Germany
facility: Research Site
city: Ibbenbueren
country: Germany
facility: Research Site
city: Immenhausen
country: Germany
facility: Research Site
city: Konstanz
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Markkleeberg
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Neu-Isenburg
country: Germany
facility: Research Site
city: Peine
country: Germany
facility: Research Site
city: Radebeul
country: Germany
facility: Research Site
city: Regensburg
country: Germany
facility: Research Site
city: Reinfeld
country: Germany
facility: Research Site
city: Rheine
country: Germany
facility: Research Site
city: Rostock
country: Germany
facility: Research Site
city: Roth
country: Germany
facility: Research Site
city: Saalfeld
country: Germany
facility: Research Site
city: Schleswig
country: Germany
facility: Research Site
city: Teuchern
country: Germany
facility: Research Site
city: Treuenbrietzen
country: Germany
facility: Research Site
city: Warendorf
country: Germany
facility: Research Site
city: Waren
country: Germany
facility: Research Site
city: Wedel
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Witten
country: Germany
facility: Research Site
Study officials:
References: