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Completed

NCT Number: NCT05677139

A Study for Observing Severe Asthma in Patients Treated With Tezepelumab

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).

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Innsbruck, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

None (Observational study)

Other

Not applicable since it's an observational study.

Other names: Observational Study

Primary outcomes

  1. Asthma Control Questionnaire (ACQ-6) score

    Time frame: Week 52

    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).

  2. Change in Asthma Control Questionnaire 6 (ACQ-6) score from Baseline

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    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

  3. Number of participants with improvement in ACQ-6 response score

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Improvement from baseline in ACQ-6 score of >=0.5 will be described.

  4. Number of participants with well-controlled asthma (ACQ-6 score ≤ 0.75)

    Time frame: Week 52

    Participant-reported asthma symptom control using ACQ-6 will be described.

  5. Time to first ACQ-6 response

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    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.

Secondary outcomes

  1. St. George's Respiratory Questionnaire (SGRQ) total score

    Time frame: Week 52

    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.

  2. Asthma Control Test (ACT) total score

    Time frame: Week 52

    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.

  3. Change from baseline in SGRQ total score

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Asthma-specific HRQoL will be described.

  4. Change from baseline in ACT total score

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Asthma-specific HRQoL will be described.

  5. Number of participants with improvement in SGRQ total score

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Improvement of ≥ 4 in SGRQ total score will be described.

  6. Number of participants with improvement in ACT total score

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Improvement of ≥ 3 in ACT total score will be described.

  7. Pre-bronchodilator forced expiratory volume in 1 second (FEV1)

    Time frame: Week 52

    Lung function will be described.

  8. Post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)

    Time frame: Week 52

    Lung function will be described.

  9. Pre BD forced vital capacity (FVC)

    Time frame: Week 52

    Lung function will be described.

  10. Post-BD FVC

    Time frame: Week 52

    Lung function will be described.

  11. Pre-BD forced expiratory flow (FEF)

    Time frame: Baseline (Week -52 to Week 0), Week 4, Week 24, and Week 52

    Lung function will be described.

  12. Changes from baseline in pre-BD FEF

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Lung function will be described.

  13. Changes from baseline in pre-BD FEV1

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Lung function will be described.

  14. Changes from baseline in post-BD FEV1

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Lung function will be described.

  15. Changes from baseline in pre-BD FVC

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Lung function will be described.

  16. Changes from baseline in post-BD FVC

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Lung function will be described

  17. Proportion of participants with spirometry and/or body plethysmography parameters

    Time frame: Week 52

    Participants will be assessed through spirometry and body plethysmography parameters

  18. Number of participants who achieve 5% or 100 mL improvement in pre-BD and post-BD FEV1

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Lung function will be described.

  19. Annualized asthma exacerbation rate (AAER)

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Annual asthma exacerbation rate is calculated in years as total number of exacerbations of interest divided by the total time at risk.

  20. Proportion of participants with asthma exacerbations

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Asthma exacerbations will be described.

  21. Proportion of participants with reduced total number of asthma exacerbations

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Proportion of participants with reduced total number of asthma exacerbations at the end of 52 weeks compared with baseline

  22. Proportion of participants who completed 52 weeks of tezepelumab treatment with at least 50% reduction in exacerbations

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Asthma exacerbations will be described.

  23. Proportion of participants who completed 52 weeks of tezepelumab treatment without an asthma exacerbation

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Asthma exacerbations in 52 weeks will be described.

  24. Change from baseline in AAER

    Time frame: Baseline (Week -52 to Week 0) to Week 52

    Asthma exacerbations will be described.

  25. Cumulative asthma exacerbation days

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Asthma exacerbations in participants resulting in any hospitalization will be described.

  26. Proportion of participants with any systemic corticosteroid (SCS) or inhaled corticosteroid (ICS) use

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Asthma related SCS or ICS use will be described.

  27. Number of participants with categorised percent reduction on cumulative systemic corticosteroids (SCS) dose

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Percent reduction on cumulative SCS dose is categorized as follows: >=25%, >=50%, >75% and 100%.

  28. Median SCS or ICS dose change

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Asthma related SCS or ICS use will be described.

  29. Proportion of participants with long-term SCS and ICS use

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Asthma related SCS or ICS use (>30 consecutive days) before and after tezepelumab initiation will be described.

  30. Time to earliest use SCS from tezepelumab initiation among patients that used SCS or ICS

    Time frame: 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 will be described.

  31. Number and type of asthma related healthcare resource utilization (HCRU)

    Time frame: Baseline (Week -52 to Week 0), Week 4, Week 12, Week 24, and Week 52

    Asthma related HCRU will be described.

  32. Annualized rates of asthma-related visits leading to hospitalization and emergency department (ED) visits, urgent care visits, or unscheduled out-patient or physician visits

    Time frame: Baseline (Week -52 to Week 0), Week 4, Week 12, Week 24, and Week 52

    Asthma related HCRU will be described.

  33. Annualized rates of asthma related physician/healthcare calls/visits

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Asthma related HCRU will be described.

  34. Duration of asthma-related hospitalisation

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Asthma related HCRU will be described.

  35. Proportion of participants with stable disease

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    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.

  36. Duration (days) of tezepelumab treatment

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Tezepelumab treatment features, including duration of therapy will be described.

  37. Proportion of participants with tezepelumab discontinuation and reason(s)

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Tezepelumab treatment features, including discontinuation and reasons for discontinuation will be described.

  38. Proportion of participants with switching to other biologics for asthma and reasons(s)

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Tezepelumab discontinuation and reasons for discontinuation will be described.

  39. Time to tezepelumab discontinuation

    Time frame: From Baseline (Week -52 to Week 0) to Week 52

    Time taken to discontinue tezepelumab will be described.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2023
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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