A Study for Observing Severe Asthma in Patients Treated With Tezepelumab
Asthma Control in Severe Asthma Patients Treated With Tezepelumab: A Prospective, Observational, Real-World Evidence Study (ASCENT)
1 other identifier
observational
513
9 countries
58
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2022
Typical duration for all trials
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2022
CompletedStudy Start
First participant enrolled
December 13, 2022
CompletedFirst Posted
Study publicly available on registry
January 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2026
CompletedMarch 16, 2026
March 1, 2026
3.2 years
November 29, 2022
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Asthma Control Questionnaire (ACQ-6) score
Participant-reported asthma symptom control using ACQ-6 will be described. The ACQ-6 was developed for self-administration by adults and adolescents by omitting the forced expiration volume in 1 second (FEV1) % predicted question. Patients are asked to record their experience with 5 symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, and wheezing) and use of short-acting. β2 agonist over the previous week using a 7-point scale (0 = no impairment; 6 = maximum impairment). The ACQ-6 score is calculated by taking the mean of the 6 equally weighted items. The ACQ-6 score range is 0 (well controlled) to 6 (extremely poorly controlled).
Week 52
Change in Asthma Control Questionnaire 6 (ACQ-6) score from Baseline
Participant-reported asthma symptom control using ACQ-6 will be described. The minimum value of ACQ-6 score is 0 and the maximum value of ACQ-6 score is 6. The ACQ-6 score of 0 indicates well tolerated asthma whereas, the ACQ-6 score of 6 indicates extremely poorly controlled asthma
From Baseline (Week -52 to Week 0) to Week 52
Number of participants with improvement in ACQ-6 response score
Improvement from baseline in ACQ-6 score of \>=0.5 will be described.
From Baseline (Week -52 to Week 0) to Week 52
Number of participants with well-controlled asthma (ACQ-6 score ≤ 0.75)
Participant-reported asthma symptom control using ACQ-6 will be described.
Week 52
Time to first ACQ-6 response
Time to first ACQ-6 response will be assessed. The ACQ-6 response is defined as change from baseline in ACQ-6 score \<= -0.5.
From Baseline (Week -52 to Week 0) to Week 52
Secondary Outcomes (39)
St. George's Respiratory Questionnaire (SGRQ) total score
Week 52
Asthma Control Test (ACT) total score
Week 52
Change from baseline in SGRQ total score
From Baseline (Week -52 to Week 0) to Week 52
Change from baseline in ACT total score
From Baseline (Week -52 to Week 0) to Week 52
Number of participants with improvement in SGRQ total score
From Baseline (Week -52 to Week 0) to Week 52
- +34 more secondary outcomes
Study Arms (1)
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.
Interventions
Not applicable since it's an observational study.
Eligibility Criteria
Participants aged 12 years or older with severe uncontrolled asthma who will commence treatment with Tezepelumab and will be enrolled from a diverse population of clinical settings. In the first wave, the study population is planned to comprise approximately 200 participants with an additional 200 participants in the second wave.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (58)
Research Site
Innsbruck, Austria
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Klagenfurt, Austria
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Vienna, Austria
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Erpent, Belgium
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Liège, Belgium
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Mouscron, Belgium
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Woluwe-Saint-Lambert, Belgium
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Yvoir, Belgium
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Calgary, Alberta, T3B 0M3, Canada
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Edmonton, Alberta, T6G 1C9, Canada
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Vancouver, British Colombia, V6E 1Y6, Canada
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Kingston, Ontario, K7M 7E4, Canada
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Toronto, Ontario, M5G 1E2, Canada
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Windsor, Ontario, N8X 5A6, Canada
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Montreal, Quebec, H1T 2M4, Canada
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Saskatoon, Saskatchewan, S7N 0W8, Canada
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Copenhagen, Denmark
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Hvidovre, Denmark
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Vejle, Denmark
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Aschaffenburg, Germany
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Auerbach, Germany
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Augsburg, Germany
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Bamberg, Germany
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Berlin, Germany
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Bonn, Germany
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Cottbus, Germany
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Düsseldorf, Germany
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Flensburg, Germany
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Freiburg im Breisgau, Germany
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Hamburg, Germany
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Hanover, Germany
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Heidelberg, Germany
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Leipzig, Germany
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Marburg, Germany
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München, Germany
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Schleswig, Germany
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Stuttgart, Germany
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Völklingen, Germany
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Wiesbaden, Germany
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Jerusalem, Israel
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Rehovot, Israel
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Tel Aviv, Israel
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Ancona, Italy
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Bergamo, Italy
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Catanzaro, Italy
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Florence, Italy
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Milan, Italy
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Naples, Italy
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Palermo, Italy
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Roma, Italy
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Siena, Italy
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Tradate, Italy
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Stockholm, Sweden
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Uppsala, Sweden
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Basel, Switzerland
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Chur, Switzerland
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Lugano, Switzerland
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Sion, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2022
First Posted
January 10, 2023
Study Start
December 13, 2022
Primary Completion
February 27, 2026
Study Completion
February 27, 2026
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.