A Study for Observing Severe Asthma in Patients Treated With Tezepelumab

Last updated: March 13, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Asthma

Treatment

None (Observational Study)

Clinical Study ID

NCT05677139
D5180R00011
  • Ages 12-130
  • All Genders

Study 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

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 symptomsconfirmed by the Investigator not to be due to alternative diagnoses

  • Received at least one prescription of medium-dose to high-dose inhaledcorticosteroids (ICS) during the 52 weeks prior to enrolment date

  • Use of additional asthma maintenance controller medication(s) for at least 52 weeksprior to enrolment date

  • Documented history of at least 1 asthma exacerbations during the 52 weeks prior toenrolment date

  • Individuals with ACQ-6 score ≥ 1.5 (indicating inadequate asthma symptom control) atenrolment 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 HealthcareResource Utilization (HCRU) for the 52 weeks prior to Tezepelumab initiation

Exclusion

Exclusion Criteria:

  • Any contraindication to Tezepelumab

  • Participants on concurrent biologics for asthma at the time of receiving the firstdose 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 aninterventional clinical trial in the last 3 months

  • Pregnancy or lactation period.

Study Design

Total Participants: 550
Treatment Group(s): 1
Primary Treatment: None (Observational Study)
Phase:
Study Start date:
December 13, 2022
Estimated Completion Date:
March 31, 2026

Study Description

This is a 12-month, multi-country, multi-center, prospective, non-comparative and non-interventional (observational), post-reimbursement real-world evidence study that will assess asthma symptom control, lung function, and patient-reported outcomes including health-related quality of life after tezepelumab treatment initiation in participants with severe asthma in Europe and Canada. This study is planned to be conducted in several countries including but not limited to Canada, Germany, Denmark, Switzerland, and Sweden.

Participants will be followed for a maximum period of 52 weeks after tezepelumab treatment initiation, irrespective of treatment discontinuation.

Connect with a study center

  • Research Site

    Innsbruck,
    Austria

    Active - Recruiting

  • Research Site

    Klagenfurt Am W Rthersee,
    Austria

    Active - Recruiting

  • Research Site

    Klagenfurt Am Worthersee,
    Austria

    Site Not Available

  • Research Site

    Wien,
    Austria

    Site Not Available

  • Research Site

    Erpent,
    Belgium

    Active - Recruiting

  • Research Site

    Gent,
    Belgium

    Site Not Available

  • Research Site

    Leuven,
    Belgium

    Site Not Available

  • Research Site

    Li Ge,
    Belgium

    Site Not Available

  • Research Site

    Liege,
    Belgium

    Active - Recruiting

  • Research Site

    Moeskroen,
    Belgium

    Active - Recruiting

  • Research Site

    Woluwe Saint Lambert,
    Belgium

    Site Not Available

  • Research Site

    Woluwe-Saint-Lambert,
    Belgium

    Active - Recruiting

  • Research Site

    Yvoir,
    Belgium

    Active - Recruiting

  • Research Site

    Calgary, Alberta T3B 0M3
    Canada

    Active - Recruiting

  • Research Site

    Edmonton, Alberta T6G 1C9
    Canada

    Site Not Available

  • Research Site

    Vancouver, British Colombia V6E 1Y6
    Canada

    Active - Recruiting

  • Research Site

    St Johns, Newfoundland and Labrador A1A 1X7
    Canada

    Site Not Available

  • Research Site

    St. John's, Newfoundland and Labrador A1A 1X7
    Canada

    Site Not Available

  • Research Site

    Kingston, Ontario K7M 7E4
    Canada

    Active - Recruiting

  • Research Site

    Mississauga, Ontario L5B 2V2
    Canada

    Site Not Available

  • Research Site

    Toronto, Ontario M5G 1E2
    Canada

    Active - Recruiting

  • Research Site

    Windsor, Ontario N8X 5A6
    Canada

    Active - Recruiting

  • Research Site

    Montr Al,, Qu Bec H1T 2M4
    Canada

    Active - Recruiting

  • Research Site

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Research Site

    Saskatoon, Saskatchewan S7N 0W8
    Canada

    Active - Recruiting

  • Research Site

    Copenhagen,
    Denmark

    Active - Recruiting

  • Research Site

    Hvidovre,
    Denmark

    Active - Recruiting

  • Research Site

    Vejle,
    Denmark

    Active - Recruiting

  • Research Site

    Aschaffenburg,
    Germany

    Active - Recruiting

  • Research Site

    Auerbach,
    Germany

    Active - Recruiting

  • Research Site

    Augsburg,
    Germany

    Active - Recruiting

  • Research Site

    Bamberg,
    Germany

    Active - Recruiting

  • Research Site

    Berlin,
    Germany

    Site Not Available

  • Research Site

    Biberach An Der Ri,
    Germany

    Site Not Available

  • Research Site

    Biberach an der Riss,
    Germany

    Site Not Available

  • Research Site

    Bonn,
    Germany

    Terminated

  • Research Site

    Cottbus,
    Germany

    Active - Recruiting

  • Research Site

    D Sseldorf,
    Germany

    Site Not Available

  • Research Site

    Delitzsch,
    Germany

    Site Not Available

  • Research Site

    Dusseldorf,
    Germany

    Terminated

  • Research Site

    Flensburg,
    Germany

    Active - Recruiting

  • Research Site

    Freiburg,
    Germany

    Active - Recruiting

  • Research Site

    Hamburg,
    Germany

    Active - Recruiting

  • Research Site

    Hanover,
    Germany

    Active - Recruiting

  • Research Site

    Heidelberg,
    Germany

    Active - Recruiting

  • Research Site

    Leipzig,
    Germany

    Active - Recruiting

  • Research Site

    Marburg,
    Germany

    Active - Recruiting

  • Research Site

    Markkleeberg,
    Germany

    Site Not Available

  • Research Site

    Munchen,
    Germany

    Active - Recruiting

  • Research Site

    Schleswig,
    Germany

    Active - Recruiting

  • Research Site

    Stuttgart,
    Germany

    Terminated

  • Research Site

    Teuchern,
    Germany

    Site Not Available

  • Research Site

    V Lklingen,
    Germany

    Active - Recruiting

  • Research Site

    Volklingen,
    Germany

    Site Not Available

  • Research Site

    Wiesbaden,
    Germany

    Active - Recruiting

  • Research Site

    Jerusalem,
    Israel

    Active - Recruiting

  • Research Site

    Rehovot,
    Israel

    Active - Recruiting

  • Research Site

    Tel Aviv,
    Israel

    Active - Recruiting

  • Research Site

    Ancona,
    Italy

    Active - Recruiting

  • Research Site

    Bergamo,
    Italy

    Site Not Available

  • Research Site

    Catanzaro,
    Italy

    Active - Recruiting

  • Research Site

    Firenze,
    Italy

    Active - Recruiting

  • Research Site

    Milano,
    Italy

    Active - Recruiting

  • Research Site

    Napoli,
    Italy

    Active - Recruiting

  • Research Site

    Padova,
    Italy

    Site Not Available

  • Research Site

    Palermo,
    Italy

    Active - Recruiting

  • Research Site

    Roma,
    Italy

    Active - Recruiting

  • Research Site

    Siena,
    Italy

    Active - Recruiting

  • Research Site

    Yradate,
    Italy

    Active - Recruiting

  • Research Site

    Stockholm,
    Sweden

    Active - Recruiting

  • Research Site

    Uppsala,
    Sweden

    Active - Recruiting

  • Research Site

    Basel,
    Switzerland

    Active - Recruiting

  • Research Site

    Chur,
    Switzerland

    Active - Recruiting

  • Research Site

    Lugano,
    Switzerland

    Active - Recruiting

  • Research Site

    Sion,
    Switzerland

    Active - Recruiting

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