Patient-Reported OUTcomes of Benralizumab in Real-World Use in Severe EosiNophilic Asthma Patients

Severe Asthma Clinical Trial

— iOUTRUN  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05603845
• Other study ID #: D3250R00113
• Status: Active, not recruiting
• Start date: February 20, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 291
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß 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

Related Conditions & MeSH terms

• Asthma
• Pulmonary Eosinophilia
• Severe Asthma

Locations

Country	Name	City	State
Brazil	Research Site	São Paulo	Sao Paulo
Colombia	Research Site	Bogota	Capital District
Colombia	Research Site	Bogota	Cundinamarca
Colombia	Research Site	Floridablanca	Santander
Colombia	Research Site	Ibague	Tolima
Colombia	Research Site	Medellin	Antioquia
Colombia	Research Site	Pereira	Risaralda
Colombia	Research Site	Soledad	Atlantico
Dominican Republic	Research Site	Ensanche la Fe	Santo Domingo
Dominican Republic	Research Site	Santiago de los Caballeros
India	Research Site	Chennai	Tamil Nadu
India	Research Site	Hyderabad	Telanagana
India	Research Site	Vadodara	Gujarat
Kuwait	Research Site	Shamiya	Shamiya-Kuwait
Qatar	Research Site	Doha
Saudi Arabia	Research Site	Jeddah
Saudi Arabia	Research Site	Jeddah
Saudi Arabia	Research Site	Riyadh	Central
Saudi Arabia	Research Site	Riyadh	Central
United Arab Emirates	Research Site	Abu Dhabi	Abu Dhabi-UAE
United Arab Emirates	Research Site	Abu Dhabi
United Arab Emirates	Research Site	Jeddah
United Arab Emirates	Research Site	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Brazil,  Colombia,  Dominican Republic,  India,  Kuwait,  Qatar,  Saudi Arabia,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline in Asthma Control Questionnaire (ACQ-6)	The changes from baseline in Asthma Control Questionnaire (ACQ-6) score at eight weeks of benralizumab treatment.; Minimum Value - '0' Maximum Value - '6' The lower the value better is the outcome	8 weeks
Secondary	Changes from baseline in Asthma Control Questionnaire (ACQ-6)	The changes from baseline in Asthma Control Questionnaire (ACQ-6) score at 1, 2, 3, 4, 24, and 56 weeks of benralizumab treatment.; Minimum Value - '0' Maximum Value - '6' The lower the value better is the outcome.	56 weeks
Secondary	Percentage of patients with a total score improvement with regards to Minimal clinically important difference in ACQ-6 (Asthma controlled questionnaire)	Percentage of patients with a total score improvement of = 0.5 points (minimal clinically important difference [MCID]) in ACQ-6 (Asthma controlled questionnaire) at 1, 2, 3, 4, 8, 24, and 56 weeks of receiving benralizumab compared to baseline Minimum Value - '0' Maximum Value - '6' The lower the value better is the outcome.	56 weeks
Secondary	Percentage of patients based on their Asthma control using ACQ-6	Percentage of patients with well-controlled asthma (ACQ-6 = 0.75), partly controlled asthma (ACQ-6 between >0.75 and <1.5), and uncontrolled asthma (ACQ-6 = 1.5) at baseline and at 1, 2, 3, 4, 8, 24, and 56 weeks of benralizumab treatment Minimum Value - '0' Maximum Value - '6' The lower the value better is the outcome.	56 weeks
Secondary	Patient global impression of change (PGI-C) response	The patient global impression of change (PGI-C) response at 1, 2, 3, 4, 8, 24, and 56 weeks of benralizumab treatment Minimum Value - '1' Maximum Value - '7' The lower the value better is the outcome	56 weeks
Secondary	Patient global impression of severity (PGI-S) response	The patient global impression of severity (PGI-S) response at 0, 1, 2, 3, 4, 8, 24, and 56 weeks of benralizumab treatment Minimum Value - '1' Maximum Value - '6' The lower the value better is the outcome	56 weeks
Secondary	Pre-bronchodilator forced expiratory volume in the first second (FEV1)	Changes in the Pre-bronchodilator forced expiratory volume in the first second (Pre BD - FEV1) Unit - "ml' It will measure the change value - The higher the better	56 weeks
Secondary	Change from baseline of the patient-reported nasal polyposis symptoms	Change from baseline using the visual analog scale (VAS) for the following parameters; Loss of smell; Nasal blockage/nasal Congestion; Difficulty with sleeping due to nasal symptoms; Headache/Pressure on face; Minimum Value - '1' Maximum Value - '10' The lower the value better is the outcome.	56 weeks
Secondary	Pre-bronchodilator forced vital capacity (FVC) changes	Change in the pre-BD Forced vital capacity (FVC) changes Unit - "ml' It will measure the change value - The higher the better	56 weeks
Secondary	Percentage of patients who achieved 100 ml improvement in their lung function	Percentage of patients who achieved 100 ml improvement in their lung function (Pre BD - FEV1) This will be measured as '%' More the value better is the outcome	56 Weeks