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A Study for Observing Severe Asthma in Patients Treated With Tezepelumab

CompletedN/A

Sponsor: AstraZeneca

Conditions: Asthma

Interventions: None (Observational Study)

Countries: Austria, Belgium, Canada, Denmark, Germany, Israel, Italy, Sweden

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 overview

Sex: ALL

Age: 12 Years to 130 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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.

Locations (58)

Innsbruck, Austria
Klagenfurt, Austria
Vienna, Austria
Erpent, Belgium
Liège, Belgium
Mouscron, Belgium
Woluwe-Saint-Lambert, Belgium
Yvoir, Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Colombia, Canada
Kingston, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Montreal, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Copenhagen, Denmark
Hvidovre, Denmark
Vejle, Denmark
Aschaffenburg, Germany
Auerbach, Germany
Augsburg, Germany
Bamberg, Germany
Berlin, Germany
Bonn, Germany
Cottbus, Germany
Düsseldorf, Germany
Flensburg, Germany
Freiburg im Breisgau, Germany
Hamburg, Germany
+ 28 more on CT.gov