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)

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).

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: None (Observational Study)

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 513

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria
    • Research Site
  • Klagenfurt, Austria
    • Research Site
  • Vienna, Austria
    • Research Site
• Belgium
  • Erpent, Belgium
    • Research Site
  • Liège, Belgium
    • Research Site
  • Mouscron, Belgium
    • Research Site
  • Woluwe-Saint-Lambert, Belgium
    • Research Site
  • Yvoir, Belgium
    • Research Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T3B 0M3
      • Research Site
    • Edmonton, Alberta, Canada, T6G 1C9
      • Research Site
  • British Colombia
    • Vancouver, British Colombia, Canada, V6E 1Y6
      • Research Site
  • Ontario
    • Kingston, Ontario, Canada, K7M 7E4
      • Research Site
    • Toronto, Ontario, Canada, M5G 1E2
      • Research Site
    • Windsor, Ontario, Canada, N8X 5A6
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Research Site
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Research Site
• Denmark
  • Copenhagen, Denmark
    • Research Site
  • Hvidovre, Denmark
    • Research Site
  • Vejle, Denmark
    • Research Site
• Germany
  • 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
  • Völklingen, Germany
    • Research Site
  • Wiesbaden, Germany
    • Research Site
• Israel
  • Jerusalem, Israel
    • Research Site
  • Rehovot, Israel
    • Research Site
  • Tel Aviv, Israel
    • Research Site
• Italy
  • Ancona, Italy
    • Research Site
  • Bergamo, Italy
    • Research Site
  • Catanzaro, Italy
    • Research Site
  • Florence, Italy
    • Research Site
  • Milan, Italy
    • Research Site
  • Napoli, Italy
    • Research Site
  • Palermo, Italy
    • Research Site
  • Roma, Italy
    • Research Site
  • Siena, Italy
    • Research Site
  • Tradate, Italy
    • Research Site
• Sweden
  • Stockholm, Sweden
    • Research Site
  • Uppsala, Sweden
    • Research Site
• Switzerland
  • Basel, Switzerland
    • Research Site
  • Chur, Switzerland
    • Research Site
  • Lugano, Switzerland
    • Research Site
  • Sion, Switzerland
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: None (Observational Study); Not applicable since it's an observational study.; Other Names: Observational Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
St. George's Respiratory Questionnaire (SGRQ) total score	Asthma-specific health-related quality of life (HRQoL) will be described. The SGRQ is a 50-item PRO instrument developed to measure the health status of patients with airway obstruction diseases. The total score indicates the impact of disease on overall health status. This total score is expressed as a percentage of overall impairment, in which 100 represents the worst possible health status and 0 indicates the best possible health status.	Week 52
Asthma Control Test (ACT) total score	Asthma-specific HRQoL will be described. The ACT is a questionnaire that assesses shortness of breath and general asthma symptoms, use of rescue medications, effect of asthma on daily functioning, and overall asthma control. Patients are asked to recall how their asthma has been during the past 4 weeks by responding to 5 questions on a scale of 1 to 5. The responses from the 5 items are summed to produce an ACT score that range from 5 (poorly controlled asthma) to 25 (well-controlled asthma). An ACT score ≥ 20 indicates well-controlled asthma, 16 to 19 indicates not well-controlled asthma, and ≤ 15 indicates very poorly controlled asthma.	Week 52
Change from baseline in SGRQ total score	Asthma-specific HRQoL will be described.	From Baseline (Week -52 to Week 0) to Week 52
Change from baseline in ACT total score	Asthma-specific HRQoL will be described.	From Baseline (Week -52 to Week 0) to Week 52
Number of participants with improvement in SGRQ total score	Improvement of ≥ 4 in SGRQ total score will be described.	From Baseline (Week -52 to Week 0) to Week 52
Number of participants with improvement in ACT total score	Improvement of ≥ 3 in ACT total score will be described.	From Baseline (Week -52 to Week 0) to Week 52
Pre-bronchodilator forced expiratory volume in 1 second (FEV1)	Lung function will be described.	Week 52
Post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)	Lung function will be described.	Week 52
Pre BD forced vital capacity (FVC)	Lung function will be described.	Week 52
Post-BD FVC	Lung function will be described.	Week 52
Pre-BD forced expiratory flow (FEF)	Lung function will be described.	Baseline (Week -52 to Week 0), Week 4, Week 24, and Week 52
Changes from baseline in pre-BD FEF	Lung function will be described.	From Baseline (Week -52 to Week 0) to Week 52
Changes from baseline in pre-BD FEV1	Lung function will be described.	From Baseline (Week -52 to Week 0) to Week 52
Changes from baseline in post-BD FEV1	Lung function will be described.	From Baseline (Week -52 to Week 0) to Week 52
Changes from baseline in pre-BD FVC	Lung function will be described.	From Baseline (Week -52 to Week 0) to Week 52
Changes from baseline in post-BD FVC	Lung function will be described	From Baseline (Week -52 to Week 0) to Week 52
Proportion of participants with spirometry and/or body plethysmography parameters	Participants will be assessed through spirometry and body plethysmography parameters	Week 52
Number of participants who achieve 5% or 100 mL improvement in pre-BD and post-BD FEV1	Lung function will be described.	From Baseline (Week -52 to Week 0) to Week 52
Annualized asthma exacerbation rate (AAER)	Annual asthma exacerbation rate is calculated in years as total number of exacerbations of interest divided by the total time at risk.	From Baseline (Week -52 to Week 0) to Week 52
Proportion of participants with asthma exacerbations	Asthma exacerbations will be described.	From Baseline (Week -52 to Week 0) to Week 52
Proportion of participants with reduced total number of asthma exacerbations	Proportion of participants with reduced total number of asthma exacerbations at the end of 52 weeks compared with baseline	From Baseline (Week -52 to Week 0) to Week 52
Proportion of participants who completed 52 weeks of tezepelumab treatment with at least 50% reduction in exacerbations	Asthma exacerbations will be described.	From Baseline (Week -52 to Week 0) to Week 52
Proportion of participants who completed 52 weeks of tezepelumab treatment without an asthma exacerbation	Asthma exacerbations in 52 weeks will be described.	From Baseline (Week -52 to Week 0) to Week 52
Change from baseline in AAER	Asthma exacerbations will be described.	Baseline (Week -52 to Week 0) to Week 52
Cumulative asthma exacerbation days	Asthma exacerbations in participants resulting in any hospitalization will be described.	From Baseline (Week -52 to Week 0) to Week 52
Proportion of participants with any systemic corticosteroid (SCS) or inhaled corticosteroid (ICS) use	Asthma related SCS or ICS use will be described.	From Baseline (Week -52 to Week 0) to Week 52
Number of participants with categorised percent reduction on cumulative systemic corticosteroids (SCS) dose	Percent reduction on cumulative SCS dose is categorized as follows: >=25%, >=50%, >75% and 100%.	From Baseline (Week -52 to Week 0) to Week 52
Median SCS or ICS dose change	Asthma related SCS or ICS use will be described.	From Baseline (Week -52 to Week 0) to Week 52
Proportion of participants with long-term SCS and ICS use	Asthma related SCS or ICS use (>30 consecutive days) before and after tezepelumab initiation will be described.	From Baseline (Week -52 to Week 0) to Week 52
Time to earliest use SCS from tezepelumab initiation among patients that used SCS or ICS	Time to earliest use SCS from tezepelumab initiation among patients that used SCS or ICS will be described.	From Baseline (Week -52 to Week 0) to Week 52
Number and type of asthma related healthcare resource utilization (HCRU)	Asthma related HCRU will be described.	Baseline (Week -52 to Week 0), Week 4, Week 12, Week 24, and Week 52
Annualized rates of asthma-related visits leading to hospitalization and emergency department (ED) visits, urgent care visits, or unscheduled out-patient or physician visits	Asthma related HCRU will be described.	Baseline (Week -52 to Week 0), Week 4, Week 12, Week 24, and Week 52
Annualized rates of asthma related physician/healthcare calls/visits	Asthma related HCRU will be described.	From Baseline (Week -52 to Week 0) to Week 52
Duration of asthma-related hospitalisation	Asthma related HCRU will be described.	From Baseline (Week -52 to Week 0) to Week 52
Proportion of participants with stable disease	Asthma disease stability is a composite endpoint consisting of ACQ-6, FEV1, exacerbations, and OCS use. The participants achieve full disease stability when they reach a meaningful improvement in all 4 parameters which is maintained to the end of the follow-up period (Week 52). This includes ACQ-6 < 1.5, Pre-BD FEV1 at Week 52/pre-BD FEV1 at baseline >0.95, 50% reduction in annualized number of exacerbations in the follow-up period, and at least ≥50% reduction in OCS use in the follow-up period.	From Baseline (Week -52 to Week 0) to Week 52
Duration (days) of tezepelumab treatment	Tezepelumab treatment features, including duration of therapy will be described.	From Baseline (Week -52 to Week 0) to Week 52
Proportion of participants with tezepelumab discontinuation and reason(s)	Tezepelumab treatment features, including discontinuation and reasons for discontinuation will be described.	From Baseline (Week -52 to Week 0) to Week 52
Proportion of participants with switching to other biologics for asthma and reasons(s)	Tezepelumab discontinuation and reasons for discontinuation will be described.	From Baseline (Week -52 to Week 0) to Week 52
Time to tezepelumab discontinuation	Time taken to discontinue tezepelumab will be described.	From Baseline (Week -52 to Week 0) to Week 52

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Actual): February 27, 2026
• Study Completion (Actual): February 27, 2026

Study Registration Dates

• First Submitted: November 29, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Severe Uncontrolled Asthma; Real-World Evidence; Inhaled corticosteroids (ICS); Post-Authorization
• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: D5180R00011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No