Change in Patient-Reported Outcomes in severe eosinophilic asthma patients treated with benralizumab under real-life conditions - imPROve

Study identifier:D3250R00053

ClinicalTrials.gov identifier:NCT04184284

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

asthma

Phase

N/A

Healthy volunteers

Study drug

Sex

All

Actual Enrollment

246

Study type

Observational

Age

18 Years - n/a

Date

Study Start Date: 15 Nov 2019

Primary Completion Date: 19 Dec 2023

Study Completion Date: 19 Dec 2023

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Jan 2024 by AstraZeneca

Collaborators

Inclusion and exclusion 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

No locations available

Arms	Assigned Interventions
Primary Study Cohort - Anti-IL5/IL5R naïve patients Severe eosinophilic asthma patients who have never received anti-Interleukin-5 / anti-Interleukin-5-receptor (anti-IL-5/anti-IL-5R) biologic treatment for severe eosinophilic asthma, for whom the investigator had decided to initiate benralizumab biologic treatment.	-
Secondary Study Cohort - Biologic experienced patients Patients that previously received a biologic treatment for severe asthma (at least one dose).	-

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]