A Study for Observing Severe Asthma in Patients Treated With Tezepelumab
NCT ID: NCT05677139
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
513 participants
OBSERVATIONAL
2022-12-13
2026-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Asthma in the United States
NCT05329194
Study to Evaluate Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma
NCT05274815
Open-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma.
NCT06473779
Patient Characteristics, Treatment Patterns and Outcomes of Patients With Severe Asthma Treated With Tezepelumab in the Real World; a Retrospective, Observational Medical Chart Review Conducted in UK Severe Asthma Centres
NCT06455462
Characterize and Assess Clinical Outcomes of Patients Receiving Tezepelumab After Marketing Approval in Spain
NCT07013760
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Participants will be followed for a maximum period of 52 weeks after tezepelumab treatment initiation, irrespective of treatment discontinuation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Prospective Cohort
Participants with severe uncontrolled asthma will receive tezepelumab. Relevant demographics, baseline clinical data, and asthma control questionnaire-6 (ACQ-6) will be retrospectively collected. All patient reported outcomes (PROs) will be prospectively collected. Other outcomes of interest (tezepelumab patterns of utilization, lung function, asthma exacerbations, medication use, and healthcare resource utilization \[HRU\]) will be collected at baseline (retrospective collection for 52-week pre-index period during enrolment) and prospectively collected during enrolment for participants who enroll into the study before the first dose of tezepelumab, and for a period of up to 52 weeks (at Weeks 4, 12, 24, and 52) after the index date. The index date is defined as the date when participants receive the first dose of tezepelumab.
None (Observational Study)
Not applicable since it's an observational study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
None (Observational Study)
Not applicable since it's an observational study.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
12 Years
130 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Innsbruck, , Austria
Research Site
Klagenfurt Am W Rthersee, , Austria
Research Site
Vienna, , Austria
Research Site
Erpent, , Belgium
Research Site
Leuven, , Belgium
Research Site
Liège, , Belgium
Research Site
Mouscron, , Belgium
Research Site
Woluwe-Saint-Lambert, , Belgium
Research Site
Yvoir, , Belgium
Research Site
Calgary, Alberta, Canada
Research Site
Edmonton, Alberta, Canada
Research Site
Vancouver, British Colombia, Canada
Research Site
Kingston, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Windsor, Ontario, Canada
Research Site
Montr Al,, Qu Bec, Canada
Research Site
Saskatoon, Saskatchewan, Canada
Research Site
Copenhagen, , Denmark
Research Site
Hvidovre, , Denmark
Research Site
Vejle, , Denmark
Research Site
Aschaffenburg, , Germany
Research Site
Auerbach, , Germany
Research Site
Augsburg, , Germany
Research Site
Bamberg, , Germany
Research Site
Berlin, , Germany
Research Site
Bonn, , Germany
Research Site
Cottbus, , Germany
Research Site
Düsseldorf, , Germany
Research Site
Flensburg, , Germany
Research Site
Freiburg im Breisgau, , Germany
Research Site
Hamburg, , Germany
Research Site
Hanover, , Germany
Research Site
Heidelberg, , Germany
Research Site
Leipzig, , Germany
Research Site
Marburg, , Germany
Research Site
München, , Germany
Research Site
Schleswig, , Germany
Research Site
Stuttgart, , Germany
Research Site
V Lklingen, , Germany
Research Site
Wiesbaden, , Germany
Research Site
Jerusalem, , Israel
Research Site
Rehovot, , Israel
Research Site
Tel Aviv, , Israel
Research Site
Ancona, , Italy
Research Site
Bergamo, , Italy
Research Site
Catanzaro, , Italy
Research Site
Florence, , Italy
Research Site
Milan, , Italy
Research Site
Napoli, , Italy
Research Site
Padua, , Italy
Research Site
Palermo, , Italy
Research Site
Roma, , Italy
Research Site
Siena, , Italy
Research Site
Yradate, , Italy
Research Site
Stockholm, , Sweden
Research Site
Uppsala, , Sweden
Research Site
Basel, , Switzerland
Research Site
Chur, , Switzerland
Research Site
Lugano, , Switzerland
Research Site
Sion, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D5180R00011
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.