A Study for Observing Severe Asthma in Patients Treated With Tezepelumab

Last updated: February 17, 2026
Sponsor: AstraZeneca
Overall Status: Active - Not 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: 513
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

    Site Not Available

  • Research Site

    Innsbruck 2775220,
    Austria

    Site Not Available

  • Research Site

    Klagenfurt Am W Rthersee,
    Austria

    Site Not Available

  • Research Site

    Klagenfurt Am Worthersee,
    Austria

    Site Not Available

  • Research Site

    Vienna 2761369,
    Austria

    Site Not Available

  • Research Site

    Wien,
    Austria

    Site Not Available

  • Research Site

    Erpent,
    Belgium

    Site Not Available

  • Research Site

    Erpent 2798674,
    Belgium

    Site Not Available

  • Research Site

    Gent,
    Belgium

    Site Not Available

  • Research Site

    Leuven,
    Belgium

    Site Not Available

  • Research Site

    Leuven 2792482,
    Belgium

    Site Not Available

  • Research Site

    Li Ge,
    Belgium

    Site Not Available

  • Research Site

    Liege,
    Belgium

    Site Not Available

  • Research Site

    Liège 2792413,
    Belgium

    Site Not Available

  • Research Site

    Moeskroen,
    Belgium

    Site Not Available

  • Research Site

    Mouscron 2790595,
    Belgium

    Site Not Available

  • Research Site

    Woluwe Saint Lambert,
    Belgium

    Site Not Available

  • Research Site

    Woluwe-Saint-Lambert,
    Belgium

    Site Not Available

  • Research Site

    Woluwe-Saint-Lambert 2783476,
    Belgium

    Site Not Available

  • Research Site

    Yvoir,
    Belgium

    Site Not Available

  • Research Site

    Yvoir 2783385,
    Belgium

    Site Not Available

  • Research Site

    Calgary, Alberta T3B 0M3
    Canada

    Site Not Available

  • Research Site

    Edmonton, Alberta T6G 1C9
    Canada

    Site Not Available

  • Research Site

    Calgary 5913490, Alberta 5883102 T3B 0M3
    Canada

    Site Not Available

  • Research Site

    Edmonton 5946768, Alberta 5883102 T6G 1C9
    Canada

    Site Not Available

  • Research Site

    Vancouver, British Colombia V6E 1Y6
    Canada

    Site Not Available

  • Research Site

    Vancouver 6173331, British Colombia V6E 1Y6
    Canada

    Site Not Available

  • 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

    Site Not Available

  • Research Site

    Mississauga, Ontario L5B 2V2
    Canada

    Site Not Available

  • Research Site

    Toronto, Ontario M5G 1E2
    Canada

    Site Not Available

  • Research Site

    Windsor, Ontario N8X 5A6
    Canada

    Site Not Available

  • Research Site

    Kingston 5992500, Ontario 6093943 K7M 7E4
    Canada

    Site Not Available

  • Research Site

    Toronto 6167865, Ontario 6093943 M5G 1E2
    Canada

    Site Not Available

  • Research Site

    Windsor 6182962, Ontario 6093943 N8X 5A6
    Canada

    Site Not Available

  • Research Site

    Montr Al,, Qu Bec H1T 2M4
    Canada

    Site Not Available

  • Research Site

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Research Site

    Saskatoon, Saskatchewan S7N 0W8
    Canada

    Site Not Available

  • Research Site

    Saskatoon 6141256, Saskatchewan 6141242 S7N 0W8
    Canada

    Site Not Available

  • Research Site

    Copenhagen,
    Denmark

    Site Not Available

  • Research Site

    Copenhagen 2618425,
    Denmark

    Site Not Available

  • Research Site

    Hvidovre,
    Denmark

    Site Not Available

  • Research Site

    Hvidovre 2619528,
    Denmark

    Site Not Available

  • Research Site

    Vejle,
    Denmark

    Site Not Available

  • Research Site

    Vejle 2610613,
    Denmark

    Site Not Available

  • Research Site

    Aschaffenburg,
    Germany

    Site Not Available

  • Research Site

    Aschaffenburg 2955272,
    Germany

    Site Not Available

  • Research Site

    Auerbach,
    Germany

    Site Not Available

  • Research Site

    Auerbach 2954602,
    Germany

    Site Not Available

  • Research Site

    Augsburg,
    Germany

    Site Not Available

  • Research Site

    Augsburg 2954172,
    Germany

    Site Not Available

  • Research Site

    Bamberg,
    Germany

    Site Not Available

  • Research Site

    Bamberg 2952984,
    Germany

    Site Not Available

  • Research Site

    Berlin,
    Germany

    Site Not Available

  • Research Site

    Berlin 2950159,
    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

    Site Not Available

  • Research Site

    Bonn 2946447,
    Germany

    Site Not Available

  • Research Site

    Cottbus,
    Germany

    Site Not Available

  • Research Site

    Cottbus 2939811,
    Germany

    Site Not Available

  • Research Site

    D Sseldorf,
    Germany

    Site Not Available

  • Research Site

    Delitzsch,
    Germany

    Site Not Available

  • Research Site

    Dusseldorf,
    Germany

    Site Not Available

  • Research Site

    Düsseldorf 2934246,
    Germany

    Site Not Available

  • Research Site

    Flensburg,
    Germany

    Site Not Available

  • Research Site

    Flensburg 2926271,
    Germany

    Site Not Available

  • Research Site

    Freiburg,
    Germany

    Site Not Available

  • Research Site

    Freiburg im Breisgau 2925177,
    Germany

    Site Not Available

  • Research Site

    Hamburg,
    Germany

    Site Not Available

  • Research Site

    Hamburg 2911298,
    Germany

    Site Not Available

  • Research Site

    Hanover,
    Germany

    Site Not Available

  • Research Site

    Hanover 2910831,
    Germany

    Site Not Available

  • Research Site

    Heidelberg,
    Germany

    Site Not Available

  • Research Site

    Heidelberg 2907911,
    Germany

    Site Not Available

  • Research Site

    Leipzig,
    Germany

    Site Not Available

  • Research Site

    Leipzig 2879139,
    Germany

    Site Not Available

  • Research Site

    Marburg,
    Germany

    Site Not Available

  • Research Site

    Marburg 2873759,
    Germany

    Site Not Available

  • Research Site

    Markkleeberg,
    Germany

    Site Not Available

  • Research Site

    Munchen,
    Germany

    Site Not Available

  • Research Site

    München 2867711,
    Germany

    Site Not Available

  • Research Site

    Schleswig,
    Germany

    Site Not Available

  • Research Site

    Schleswig 2838634,
    Germany

    Site Not Available

  • Research Site

    Stuttgart,
    Germany

    Site Not Available

  • Research Site

    Stuttgart 2825297,
    Germany

    Site Not Available

  • Research Site

    Teuchern,
    Germany

    Site Not Available

  • Research Site

    V Lklingen,
    Germany

    Site Not Available

  • Research Site

    Volklingen,
    Germany

    Site Not Available

  • Research Site

    Wiesbaden,
    Germany

    Site Not Available

  • Research Site

    Wiesbaden 2809346,
    Germany

    Site Not Available

  • Research Site

    Jerusalem,
    Israel

    Site Not Available

  • Research Site

    Jerusalem 281184,
    Israel

    Site Not Available

  • Research Site

    Rehovot,
    Israel

    Site Not Available

  • Research Site

    Rehovot 293725,
    Israel

    Site Not Available

  • Research Site

    Tel Aviv,
    Israel

    Site Not Available

  • Research Site

    Tel Aviv 293397,
    Israel

    Site Not Available

  • Research Site

    Ancona,
    Italy

    Site Not Available

  • Research Site

    Ancona 3183089,
    Italy

    Site Not Available

  • Research Site

    Bergamo,
    Italy

    Site Not Available

  • Research Site

    Bergamo 3182164,
    Italy

    Site Not Available

  • Research Site

    Catanzaro,
    Italy

    Site Not Available

  • Research Site

    Catanzaro 2525059,
    Italy

    Site Not Available

  • Research Site

    Firenze,
    Italy

    Site Not Available

  • Research Site

    Florence 3176959,
    Italy

    Site Not Available

  • Research Site

    Milan 6951411,
    Italy

    Site Not Available

  • Research Site

    Milano,
    Italy

    Site Not Available

  • Research Site

    Napoli,
    Italy

    Site Not Available

  • Research Site

    Napoli 9031661,
    Italy

    Site Not Available

  • Research Site

    Padova,
    Italy

    Site Not Available

  • Research Site

    Padua 3171728,
    Italy

    Site Not Available

  • Research Site

    Palermo,
    Italy

    Site Not Available

  • Research Site

    Palermo 2523920,
    Italy

    Site Not Available

  • Research Site

    Roma,
    Italy

    Site Not Available

  • Research Site

    Roma 8957247,
    Italy

    Site Not Available

  • Research Site

    Siena,
    Italy

    Site Not Available

  • Research Site

    Siena 3166548,
    Italy

    Site Not Available

  • Research Site

    Yradate,
    Italy

    Site Not Available

  • Research Site

    Stockholm,
    Sweden

    Site Not Available

  • Research Site

    Stockholm 2673730,
    Sweden

    Site Not Available

  • Research Site

    Uppsala,
    Sweden

    Site Not Available

  • Research Site

    Uppsala 2666199,
    Sweden

    Site Not Available

  • Research Site

    Basel,
    Switzerland

    Site Not Available

  • Research Site

    Basel 2661604,
    Switzerland

    Site Not Available

  • Research Site

    Chur,
    Switzerland

    Site Not Available

  • Research Site

    Chur 2661169,
    Switzerland

    Site Not Available

  • Research Site

    Lugano,
    Switzerland

    Site Not Available

  • Research Site

    Lugano 2659836,
    Switzerland

    Site Not Available

  • Research Site

    Sion,
    Switzerland

    Site Not Available

  • Research Site

    Sion 2658576,
    Switzerland

    Site Not Available

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