AsthmaNCT05677139
A Study for Observing Severe Asthma in Patients Treated With Tezepelumab
An observational study of Asthma, run by AstraZeneca at 58 sites in 9 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 130 years
- Conditions the study is for
- Asthma
- What is being tested?
- None (Observational Study)
- How many people
- 513 participants
- Where
- 58 sitesin 9 countries
- Study dates
- 13 Dec 2022to 27 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 130 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
58 sites in 9 countries.
58 sites in 9 countries
Germany20 sites
Research Site
Aschaffenburg
Research Site
Auerbach
Research Site
Augsburg
Research Site
Bamberg
Research Site
Berlin
Research Site
Bonn
Research Site
Cottbus
Research Site
Düsseldorf
Research Site
Flensburg
Research Site
Freiburg im Breisgau
Research Site
Hamburg
Research Site
Hanover
Research Site
Heidelberg
Research Site
Leipzig
Research Site
Marburg
Research Site
München
Research Site
Schleswig
Research Site
Stuttgart
Research Site
Völklingen
Research Site
Wiesbaden
Italy10 sites
Research Site
Ancona
Research Site
Bergamo
Research Site
Catanzaro
Research Site
Florence
Research Site
Milan
Research Site
Naples
Research Site
Palermo
Research Site
Roma
Research Site
Siena
Research Site
Tradate
Canada8 sites
Research Site
Calgary, Alberta, T3B 0M3
Research Site
Edmonton, Alberta, T6G 1C9
Research Site
Kingston, Ontario, K7M 7E4
Research Site
Montreal, Quebec, H1T 2M4
Research Site
Saskatoon, Saskatchewan, S7N 0W8
Research Site
Toronto, Ontario, M5G 1E2
Research Site
Vancouver, British Colombia, V6E 1Y6
Research Site
Windsor, Ontario, N8X 5A6
Belgium5 sites
Research Site
Erpent
Research Site
Liège
Research Site
Mouscron
Research Site
Woluwe-Saint-Lambert
Research Site
Yvoir
Switzerland4 sites
Research Site
Basel
Research Site
Chur
Research Site
Lugano
Research Site
Sion
Austria3 sites
Research Site
Innsbruck
Research Site
Klagenfurt
Research Site
Vienna
Denmark3 sites
Research Site
Copenhagen
Research Site
Hvidovre
Research Site
Vejle
Israel3 sites
Research Site
Jerusalem
Research Site
Rehovot
Research Site
Tel Aviv
About this study
Official title: 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).
Read the 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.
- Conditions
- Asthma
- Being tested
- None (Observational Study)
- Keywords
- Real-World Evidence, Severe Uncontrolled Asthma, Inhaled corticosteroids (ICS), Post-Authorization
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (Observational Study)Other
Also called Observational Study
Not applicable since it's an observational study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: None (Observational Study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline (Week -52 to Week 0) to Week 52
Secondary outcomes (39)
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.
Measured: 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.
Measured: Week 52
Change from baseline in SGRQ total score
Asthma-specific HRQoL will be described.
Measured: From Baseline (Week -52 to Week 0) to Week 52
Change from baseline in ACT total score
Asthma-specific HRQoL will be described.
Measured: 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.
Measured: 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.
Measured: From Baseline (Week -52 to Week 0) to Week 52
Pre-bronchodilator forced expiratory volume in 1 second (FEV1)
Lung function will be described.
Measured: Week 52
Post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
Lung function will be described.
Measured: Week 52
Pre BD forced vital capacity (FVC)
Lung function will be described.
Measured: Week 52
Post-BD FVC
Lung function will be described.
Measured: Week 52
Pre-BD forced expiratory flow (FEF)
Lung function will be described.
Measured: 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.
Measured: From Baseline (Week -52 to Week 0) to Week 52
Changes from baseline in pre-BD FEV1
Lung function will be described.
Measured: From Baseline (Week -52 to Week 0) to Week 52
Changes from baseline in post-BD FEV1
Lung function will be described.
Measured: From Baseline (Week -52 to Week 0) to Week 52
Changes from baseline in pre-BD FVC
Lung function will be described.
Measured: From Baseline (Week -52 to Week 0) to Week 52
Changes from baseline in post-BD FVC
Lung function will be described
Measured: 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
Measured: Week 52
Number of participants who achieve 5% or 100 mL improvement in pre-BD and post-BD FEV1
Lung function will be described.
Measured: 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.
Measured: From Baseline (Week -52 to Week 0) to Week 52
Proportion of participants with asthma exacerbations
Asthma exacerbations will be described.
Measured: 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
Measured: 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.
Measured: 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.
Measured: From Baseline (Week -52 to Week 0) to Week 52
Change from baseline in AAER
Asthma exacerbations will be described.
Measured: Baseline (Week -52 to Week 0) to Week 52
Cumulative asthma exacerbation days
Asthma exacerbations in participants resulting in any hospitalization will be described.
Measured: 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.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline (Week -52 to Week 0) to Week 52
Duration of asthma-related hospitalisation
Asthma related HCRU will be described.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From Baseline (Week -52 to Week 0) to Week 52
Time to tezepelumab discontinuation
Time taken to discontinue tezepelumab will be described.
Measured: From Baseline (Week -52 to Week 0) to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start13 Dec 2022
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 513 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677139
- Sponsor's protocol ID
- D5180R00011
- Status last verified
- Mar 2026
- First submitted
- 29 Nov 2022
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Milger K, Dorscheid D, Gessner C, Hilberg O, Llanos JP, Natman J, Urbanski H, Clarke DL, Emmanuel B, Stjepanovic N. Early and continued asthma control up to week 24 in patients with severe, uncontrolled asthma treated with tezepelumab: Initial results of the real-world ASCENT study. Respir Med. 2026 Aug 6:109075. doi: 10.1016/j.rmed.2026.109075. Online ahead of print.
PubMed 42562237
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asthma Control in Severe Asthma Patients Treated With Tezepelumab: A Prospective, Observational, Real-World Evidence Study (ASCENT)
- ClinicalTrials.gov ID
- NCT05677139
- Acronym / sponsor ID
- D5180R00011
- Conditions
- Asthma
- Keywords
- Real-World Evidence, Severe Uncontrolled Asthma, Inhaled corticosteroids (ICS), Post-Authorization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | Other: None (Observational Study)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. |
Who may qualify
- Ages
- 12 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None (Observational Study)Also: Observational StudyNot applicable since it's an observational study. | Other | Prospective Cohort |
Primary outcome
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).
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
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.
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.
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.
39 secondary outcomes
St. George's Respiratory Questionnaire (SGRQ) total score
Time frame: Week 52
Asthma Control Test (ACT) total score
Time frame: Week 52
Change from baseline in SGRQ total score
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Change from baseline in ACT total score
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Number of participants with improvement in SGRQ total score
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Number of participants with improvement in ACT total score
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Pre-bronchodilator forced expiratory volume in 1 second (FEV1)
Time frame: Week 52
Post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
Time frame: Week 52
Pre BD forced vital capacity (FVC)
Time frame: Week 52
Post-BD FVC
Time frame: Week 52
Pre-BD forced expiratory flow (FEF)
Time frame: Baseline (Week -52 to Week 0), Week 4, Week 24, and Week 52
Changes from baseline in pre-BD FEF
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Changes from baseline in pre-BD FEV1
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Changes from baseline in post-BD FEV1
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Changes from baseline in pre-BD FVC
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Changes from baseline in post-BD FVC
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Proportion of participants with spirometry and/or body plethysmography parameters
Time frame: Week 52
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
Annualized asthma exacerbation rate (AAER)
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Proportion of participants with asthma exacerbations
Time frame: From Baseline (Week -52 to Week 0) to Week 52
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 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
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
Change from baseline in AAER
Time frame: Baseline (Week -52 to Week 0) to Week 52
Cumulative asthma exacerbation days
Time frame: From Baseline (Week -52 to Week 0) to Week 52
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
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
Median SCS or ICS dose change
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Proportion of participants with long-term SCS and ICS use
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
Time frame: From Baseline (Week -52 to Week 0) to Week 52
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
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
Annualized rates of asthma related physician/healthcare calls/visits
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Duration of asthma-related hospitalisation
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Proportion of participants with stable disease
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Duration (days) of tezepelumab treatment
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Proportion of participants with tezepelumab discontinuation and reason(s)
Time frame: From Baseline (Week -52 to Week 0) to Week 52
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
Time to tezepelumab discontinuation
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Derived from this study: PubMed 42562237Milger K, Dorscheid D, Gessner C, Hilberg O, Llanos JP, Natman J, Urbanski H, Clarke DL, Emmanuel B, Stjepanovic N. Early and continued asthma control up to week 24 in patients with severe, uncontrolled asthma treated with tezepelumab: Initial results of the real-world ASCENT study. Respir Med. 2026 Aug 6:109075. doi: 10.1016/j.rmed.2026.109075. Online ahead of print.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
58 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by AstraZeneca at 58 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in Germany, Italy, Canada, Belgium, Switzerland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Questionnaire (ACQ-6) score (time frame: Week 52). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05677139, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.