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NCT05677139
A Study for Observing Severe Asthma in Patients Treated With Tezepelumab
Conditions: Asthma
Sex: All
Ages: 12 Years – N/A
Enrollment: 200
Sponsor: AstraZeneca
Location: Canada
Summary
A study involving primary data collection within real-world settings of participants who initiate treatment with tezepelumab for severe uncontrolled asthma.
This study will complement evidence obtained from randomized controlled trials and provide new data focusing on the holistic and patient reported outcome (PRO).
Eligibility Criteria
Inclusion Criteria:Male or female participants aged 12 years or olderProvision of signed and dated written informed consent, including assent for minorsPrescribed treatment with TezepelumabDiagnosis of asthma for at least 52 weeks prior to enrolment date and symptoms confirmed by the Investigator not to be due to alternative diagnosesReceived at least one prescription of medium-dose to high-dose inhaled corticosteroids (ICS) during the 52 weeks prior to enrolment dateUse of additional asthma maintenance controller medication(s) for at least 52 weeks prior to enrolment dateDocumented history of at least 1 asthma exacerbations during the 52 weeks prior to enrolment dateIndividuals with ACQ-6 score ≥ 1.5 (indicating inadequate asthma symptom control) at enrolment or up to 12 weeks before enrolmentParticipants currently receiving care from pulmonologists and/or allergistsParticipants who are able to understand and complete the ePROsAvailability of participants medical records for asthma exacerbation and Healthcare Resource Utilization (HCRU) for the 52 weeks prior to Tezepelumab initiationExclusion Criteria:Any contraindication to TezepelumabParticipants on concurrent biologics for asthma at the time of receiving the first dose of Tezepelumab will be excluded except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment)Participation in an observational study that might, in the Investigator's opinion, influence the assessment for the current study, or participation in an interventional clinical trial in the last 3 monthsPregnancy or lactation period.
Source: ClinicalTrials.gov (NCT05677139). StuddyBuddy aggregates publicly available trial information.