Clinical trial NCT05603845: Patient-Reported OUTcomes of Benralizumab in Real-World Use in Severe EosiNophilic Asthma Patients
Official title: Patient-Reported OUTcomes of Benralizumab in Real-World Use in Severe EosiNophilic Asthma Patients Multicountry, Multicenter, Observational, Prospective, Primary Data, Real-world Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Asthma
Keywords: Severe Asthma
Benralizumab
Eosinophilic asthma
Patient reported outcomes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-11-03
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will recruit 410 adult patients with confirmed severe eosinophilic asthma who meet all inclusion criteria and none of the exclusion criteria in 9 countries as described above.

Approximately 6-8 hospitals per country will participate in the study which have previous experience with biologic treatment, can initiate treatment with benralizumab, and have a good oversight on the severe asthma population.

Brief summary: This study aims to generate real-world data on the characteristics of patients receiving benralizumab to assess early PRO parameters as well as long-term treatment effects in the Gulf cooperative council (Kingdom of Saudi Arabia, Kuwait, United Arab Emirates, Oman, and Qatar), Latin America (Brazil, Argentina, and Colombia), and India. It is anticipated that the data generated will provide practical, patient-focused real-world evidence and enhance communications between patients and physicians in an objective and structured manner to ensure better disease control in patients under benralizumab treatment.

Detailed description: This is a multi-country, multi-center, observational, prospective study involving primary data collection within real-world pulmonary care settings for patients who receive benralizumab treatment for severe uncontrolled eosinophilic asthma.The decision by the physician to start benralizumab is made independently from study inclusion and patient informed consent. Patients will receive benralizumab injections according to the local label in the participating countries (Brazil, Argentina, Colombia, India, and the Gulf cooperative council, including the Kingdom of Saudi Arabia, United Arab Emirates, Kuwait, Oman, and Qatar). No study drug will be provided as part of the study. The entire study period duration will be 56 weeks for each subject. The study is anticipated to run for approximately 18 months and is not anticipated to exceed 24 months. A database soft lock is planned at the end of the initial 8-week period of the study, and one combined descriptive and analytical interim analysis will be performed when 50% of the enrolled subjects complete the 8-week follow-up.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients aged 18 years or older with a physician's confirmed diagnosis of severe eosinophilic, uncontrolled asthma.
2. Severe uncontrolled eosinophilic asthma requiring high-dose\* inhaled corticosteroid plus long-acting β adrenoceptor agonist as maintenance treatment.
3. Patients who have been prescribed but not yet initiated treatment with benralizumab (Fasenra®) according to local approved prescribing information prior to signed informed consent.
4. Provision of the signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation.
5. Patients must be able and willing to read and comprehend written instructions and complete the paper PRO questionnaires required by the protocol.

Exclusion Criteria:

1. Clinically important pulmonary diseases other than asthma including chronic obstructive pulmonary disease (as the 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).
2. Currently enrolled in an interventional clinical study except patients being in parallel documented in a national asthma registry
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.
4. Concurrent biologics for asthma are not allowed. Acceptable wash-out periods for other asthma biologics: ≥30 days from the last dose of the previous biologic.
5. Women who are currently pregnant, breastfeeding, or lactating

Primary outcomes:
measure: Changes from baseline in Asthma Control Questionnaire (ACQ-6)
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes from baseline in Asthma Control Questionnaire (ACQ-6)
timeFrame: 56 weeks
measure: Percentage of patients with a total score improvement with regards to Minimal clinically important difference in ACQ-6 (Asthma controlled questionnaire)
timeFrame: 56 weeks
measure: Percentage of patients based on their Asthma control using ACQ-6
timeFrame: 56 weeks
measure: Patient global impression of change (PGI-C) response
timeFrame: 56 weeks
measure: Patient global impression of severity (PGI-S) response
timeFrame: 56 weeks
measure: Pre-bronchodilator forced expiratory volume in the first second (FEV1)
timeFrame: 56 weeks
measure: Change from baseline of the patient-reported nasal polyposis symptoms
timeFrame: 56 weeks
measure: Pre-bronchodilator forced vital capacity (FVC) changes
timeFrame: 56 weeks
measure: Percentage of patients who achieved 100 ml improvement in their lung function
timeFrame: 56 Weeks
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Research Site
city: Bucaramanga
country: Colombia
facility: Research Site
city: Ibague
country: Colombia
facility: Research Site
city: Pereira
country: Colombia
facility: Research Site
city: Santiago
country: Dominican Republic
facility: Research Site
city: Santo Domingo
country: Dominican Republic
facility: Research Site
city: Ahmedabad
country: India
facility: Research Site
city: Ajmer
country: India
facility: Research Site
city: Chennai
country: India
facility: Research Site
city: Delhi
country: India
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
city: Jaipur
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: Pune
country: India
facility: Research Site
city: Secundrabad
country: India
facility: Research Site
city: Vadodara
country: India
facility: Research Site
city: Sabah Al Salem
country: Kuwait
facility: Research Site
city: Muscat
country: Oman
facility: Research Site
city: Doha
country: Qatar
facility: Research Site
city: Jeddah
country: Saudi Arabia
facility: Research Site
city: Riyadh
country: Saudi Arabia
facility: Research Site
city: Abu Dhabi
country: United Arab Emirates
facility: Research Site
city: Al Ain
country: United Arab Emirates
facility: Research Site
city: Dubai
country: United Arab Emirates
facility: Research Site
Study officials:
References: