Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT05603845

CompletedN/A

Sponsor: AstraZeneca

Conditions: Severe Asthma

Countries: Colombia, Dominican Republic, India, Kuwait, Oman, Qatar, Saudi Arabia, United Arab Emirates

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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
Locations (24)
  • Bogotá, Colombia
  • Bucaramanga, Colombia
  • Ibague, Colombia
  • Pereira, Colombia
  • Santiago de los Caballeros, Dominican Republic
  • Santo Domingo, Dominican Republic
  • Ahmedabad, India
  • Ajmer, India
  • Chennai, India
  • Delhi, India
  • Hyderabad, India
  • Jaipur, India
  • Kolkata, India
  • Pune, India
  • Secundrabad, India
  • Vadodara, India
  • Sabah Al Salem, Kuwait
  • Muscat, Oman
  • Doha, Qatar
  • Jeddah, Saudi Arabia
  • Riyadh, Saudi Arabia
  • Abu Dhabi, United Arab Emirates
  • Al Ain City, United Arab Emirates
  • Dubai, United Arab Emirates