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Observing severe asthma patients treated with tezepelumab

Asthma Control in Severe Asthma Patients Treated With Tezepelumab: A Prospective, Observational, Real-World Evidence Study (ASCENT)

AstraZeneca · NCT05677139

This study is tracking patients with severe asthma who start using tezepelumab to see how well it helps control their symptoms and improve their overall health over a year.

Quick facts

Study typeObservational
Enrollment550 (estimated)
Ages12 Years to 130 Years
SexAll
SponsorAstraZeneca (industry)
Drugs / interventionsTezepelumab, immunotherapy
Locations71 sites (Innsbruck and 70 other locations)
Trial IDNCT05677139 on ClinicalTrials.gov

What this trial studies

This observational study collects real-world data from patients initiating treatment with tezepelumab for severe uncontrolled asthma. Over a 12-month period, participants will be monitored across multiple countries, including Canada and several European nations, to assess asthma symptom control, lung function, and patient-reported outcomes. The study aims to complement existing clinical trial data by focusing on holistic patient experiences and outcomes. Participants will be followed for up to 52 weeks, regardless of whether they continue treatment.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 12 years or older with a diagnosis of severe asthma who have been prescribed tezepelumab and have a documented history of asthma exacerbations.

Not a fit: Patients who do not have a diagnosis of asthma or those who have not been prescribed tezepelumab will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of tezepelumab in real-world settings, potentially improving asthma management for patients.

How similar studies have performed: Other studies have shown success in utilizing real-world evidence to assess treatment outcomes in asthma, making this approach both relevant and valuable.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Innsbruck and 70 other locations

+21 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Asthma, Real-World Evidence, Severe Uncontrolled Asthma, Inhaled corticosteroids, Post-Authorization

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.