A Study for Observing Severe Asthma in Patients Treated With Tezepelumab
AsthmaA 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).
null
Participation Requirements
-
Sex:
ALL -
Eligible Ages:
12 and up
Participation Criteria
Inclusion Criteria:
* Male or female participants aged 12 years or older
* Provision of signed and dated written informed consent, including assent for minors
* Prescribed treatment with Tezepelumab
* Diagnosis of asthma for at least 52 weeks prior to enrolment date and symptoms confirmed by the Investigator not to be due to alternative diagnoses
* Received at least one prescription of medium-dose to high-dose inhaled corticosteroids (ICS) during the 52 weeks prior to enrolment date
* Use of additional asthma maintenance controller medication(s) for at least 52 weeks prior to enrolment date
* Documented history of at least 1 asthma exacerbations during the 52 weeks prior to enrolment date
* Individuals with ACQ-6 score ≥ 1.5 (indicating inadequate asthma symptom control) at enrolment or up to 12 weeks before enrolment
* Participants currently receiving care from pulmonologists and/or allergists
* Participants who are able to understand and complete the ePROs
* Availability of participants medical records for asthma exacerbation and Healthcare Resource Utilization (HCRU) for the 52 weeks prior to Tezepelumab initiation
Exclusion Criteria:
* Any contraindication to Tezepelumab
* Participants 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 months
* Pregnancy or lactation period.
Study Location
Research Site
Research SiteVancouver, British Colombia
Canada
Contact Study Team
Research Site
Research SiteToronto, Ontario
Canada
Contact Study Team
Research Site
Research SiteEdmonton, Alberta
Canada
Contact Study Team
Research Site
Research SiteMississauga, Ontario
Canada
Contact Study Team
Research Site
Research SiteSaskatoon, Saskatchewan
Canada
Contact Study Team
Research Site
Research SiteSt. John's, Newfoundland and Labrador
Canada
Contact Study Team
Research Site
Research SiteWindsor, Ontario
Canada
Contact Study Team
Research Site
Research SiteCalgary, Alberta
Canada
Contact Study Team
Research Site
Research SiteKingston, Ontario
Canada
Contact Study Team
Research Site
Research SiteMontr Al,, Qu Bec
Canada
Contact Study Team
- Study Sponsored By
- AstraZeneca
- Participants Required
- More Information
- Study ID:
NCT05677139