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).
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
513
Not applicable since it's an observational study.
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).
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Baseline (Week -52 to Week 0) to Week 52
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Research Site
Innsbruck, Austria
Research Site
Klagenfurt, Austria
Research Site
Vienna, Austria
Research Site
Erpent, 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
...and 48 more locations
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.
Time frame: 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.
Time frame: Week 52
Change from baseline in SGRQ total score
Asthma-specific HRQoL will be described.
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Change from baseline in ACT total score
Asthma-specific HRQoL will be described.
Time frame: 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.
Time frame: 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.
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Pre-bronchodilator forced expiratory volume in 1 second (FEV1)
Lung function will be described.
Time frame: Week 52
Post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
Lung function will be described.
Time frame: Week 52
Pre BD forced vital capacity (FVC)
Lung function will be described.
Time frame: Week 52
Post-BD FVC
Lung function will be described.
Time frame: Week 52
Pre-BD forced expiratory flow (FEF)
Lung function will be described.
Time frame: 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.
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Changes from baseline in pre-BD FEV1
Lung function will be described.
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Changes from baseline in post-BD FEV1
Lung function will be described.
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Changes from baseline in pre-BD FVC
Lung function will be described.
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Changes from baseline in post-BD FVC
Lung function will be described
Time frame: 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
Time frame: Week 52
Number of participants who achieve 5% or 100 mL improvement in pre-BD and post-BD FEV1
Lung function will be described.
Time frame: 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.
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Proportion of participants with asthma exacerbations
Asthma exacerbations will be described.
Time frame: 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
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
Asthma exacerbations will be described.
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
Asthma exacerbations in 52 weeks will be described.
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Change from baseline in AAER
Asthma exacerbations will be described.
Time frame: Baseline (Week -52 to Week 0) to Week 52
Cumulative asthma exacerbation days
Asthma exacerbations in participants resulting in any hospitalization will be described.
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
Asthma related SCS or ICS use will be described.
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
Percent reduction on cumulative SCS dose is categorized as follows: \>=25%, \>=50%, \>75% and 100%.
Time frame: 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.
Time frame: 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.
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 to earliest use SCS from tezepelumab initiation among patients that used SCS or ICS will be described.
Time frame: 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.
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
Asthma related HCRU will be described.
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
Asthma related HCRU will be described.
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Duration of asthma-related hospitalisation
Asthma related HCRU will be described.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
Tezepelumab discontinuation and reasons for discontinuation will be described.
Time frame: From Baseline (Week -52 to Week 0) to Week 52
Time to tezepelumab discontinuation
Time taken to discontinue tezepelumab will be described.
Time frame: From Baseline (Week -52 to Week 0) to Week 52