A Study for Observing Severe Asthma in Patients Treated With Tezepelumab
- Conditions
- Asthma
- Interventions
- Other: None (Observational Study)
- Registration Number
- NCT05677139
- Lead Sponsor
- AstraZeneca
- 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).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 550
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prospective Cohort 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.
- Primary Outcome Measures
Name Time Method Number of participants with well-controlled asthma (ACQ-6 score ≤ 0.75) Week 52 Participant-reported asthma symptom control using ACQ-6 will be described.
Number of participants with improvement in ACQ-6 response score From Baseline (Week -52 to Week 0) to Week 52 Improvement from baseline in ACQ-6 score of \>=0.5 will be described.
Change in Asthma Control Questionnaire 6 (ACQ-6) score from Baseline 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
Time to first ACQ-6 response 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.
Asthma Control Questionnaire (ACQ-6) score 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).
- Secondary Outcome Measures
Name Time Method Change from baseline in SGRQ total score From Baseline (Week -52 to Week 0) to Week 52 Asthma-specific HRQoL will be described.
Change from baseline in ACT total score From Baseline (Week -52 to Week 0) to Week 52 Asthma-specific HRQoL will be described.
Number of participants with improvement in SGRQ total score From Baseline (Week -52 to Week 0) to Week 52 Improvement of ≥ 4 in SGRQ total score will be described.
Number of participants with improvement in ACT total score From Baseline (Week -52 to Week 0) to Week 52 Improvement of ≥ 3 in ACT total score will be described.
Pre-bronchodilator forced expiratory volume in 1 second (FEV1) Week 52 Lung function will be described.
Post-BD FVC Week 52 Lung function will be described.
Number of participants who achieve 5% or 100 mL improvement in pre-BD and post-BD FEV1 From Baseline (Week -52 to Week 0) to Week 52 Lung function will be described.
Proportion of participants with asthma exacerbations From Baseline (Week -52 to Week 0) to Week 52 Asthma exacerbations will be described.
Median SCS or ICS dose change From Baseline (Week -52 to Week 0) to Week 52 Asthma related SCS or ICS use will be described.
Time to earliest use SCS from tezepelumab initiation among patients that used SCS or ICS 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.
Annualized rates of asthma-related visits leading to hospitalization and emergency department (ED) visits, urgent care visits, or unscheduled out-patient or physician visits Baseline (Week -52 to Week 0), Week 4, Week 12, Week 24, and Week 52 Asthma related HCRU will be described.
Annualized rates of asthma related physician/healthcare calls/visits From Baseline (Week -52 to Week 0) to Week 52 Asthma related HCRU will be described.
Duration of asthma-related hospitalisation From Baseline (Week -52 to Week 0) to Week 52 Asthma related HCRU will be described.
St. George's Respiratory Questionnaire (SGRQ) total score 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.
Changes from baseline in pre-BD FEV1 From Baseline (Week -52 to Week 0) to Week 52 Lung function will be described.
Changes from baseline in pre-BD FVC From Baseline (Week -52 to Week 0) to Week 52 Lung function will be described.
Proportion of participants with spirometry and/or body plethysmography parameters Week 52 Participants will be assessed through spirometry and body plethysmography parameters
Annualized asthma exacerbation rate (AAER) 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.
Proportion of participants with reduced total number of asthma exacerbations 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
Proportion of participants who completed 52 weeks of tezepelumab treatment with at least 50% reduction in exacerbations From Baseline (Week -52 to Week 0) to Week 52 Asthma exacerbations will be described.
Proportion of participants with tezepelumab discontinuation and reason(s) From Baseline (Week -52 to Week 0) to Week 52 Tezepelumab treatment features, including discontinuation and reasons for discontinuation will be described.
Time to tezepelumab discontinuation From Baseline (Week -52 to Week 0) to Week 52 Time taken to discontinue tezepelumab will be described.
Asthma Control Test (ACT) total score 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.
Number and type of asthma related healthcare resource utilization (HCRU) Baseline (Week -52 to Week 0), Week 4, Week 12, Week 24, and Week 52 Asthma related HCRU will be described.
Post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) Week 52 Lung function will be described.
Change from baseline in AAER Baseline (Week -52 to Week 0) to Week 52 Asthma exacerbations will be described.
Pre BD forced vital capacity (FVC) Week 52 Lung function will be described.
Pre-BD forced expiratory flow (FEF) Baseline (Week -52 to Week 0), Week 4, Week 24, and Week 52 Lung function will be described.
Changes from baseline in pre-BD FEF From Baseline (Week -52 to Week 0) to Week 52 Lung function will be described.
Changes from baseline in post-BD FEV1 From Baseline (Week -52 to Week 0) to Week 52 Lung function will be described.
Changes from baseline in post-BD FVC From Baseline (Week -52 to Week 0) to Week 52 Lung function will be described
Proportion of participants who completed 52 weeks of tezepelumab treatment without an asthma exacerbation From Baseline (Week -52 to Week 0) to Week 52 Asthma exacerbations in 52 weeks will be described.
Cumulative asthma exacerbation days From Baseline (Week -52 to Week 0) to Week 52 Asthma exacerbations in participants resulting in any hospitalization will be described.
Proportion of participants with any systemic corticosteroid (SCS) or inhaled corticosteroid (ICS) use From Baseline (Week -52 to Week 0) to Week 52 Asthma related SCS or ICS use will be described.
Number of participants with categorised percent reduction on cumulative systemic corticosteroids (SCS) dose 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%.
Proportion of participants with stable disease 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.
Duration (days) of tezepelumab treatment From Baseline (Week -52 to Week 0) to Week 52 Tezepelumab treatment features, including duration of therapy will be described.
Proportion of participants with switching to other biologics for asthma and reasons(s) From Baseline (Week -52 to Week 0) to Week 52 Tezepelumab discontinuation and reasons for discontinuation will be described.
Proportion of participants with long-term SCS and ICS use 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.
Trial Locations
- Locations (1)
Research Site
🇨🇭Sion, Switzerland