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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None (Observational Study) | Other | Not applicable since it's an observational study. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Innsbruck | Austria | ||||
| Research Site |
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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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.
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.
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| 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 |
| 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 | T3B 0M3 | Canada |
| Research Site | Edmonton | Alberta | T6G 1C9 | Canada |
| Research Site | Vancouver | British Colombia | V6E 1Y6 | Canada |
| Research Site | Kingston | Ontario | K7M 7E4 | Canada |
| Research Site | Toronto | Ontario | M5G 1E2 | Canada |
| Research Site | Windsor | Ontario | N8X 5A6 | Canada |
| Research Site | Montreal | Quebec | H1T 2M4 | Canada |
| Research Site | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Research Site | Copenhagen | Denmark |
| Research Site | Hvidovre | Denmark |
| Research Site | Vejle | Denmark |
| Research Site | 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 | Jerusalem | Israel |
| Research Site | Rehovot | Israel |
| Research Site | Tel Aviv | Israel |
| Research Site | Ancona | Italy |
| Research Site | Bergamo | Italy |
| Research Site | Catanzaro | Italy |
| Research Site | Florence | Italy |
| Research Site | Milan | Italy |
| Research Site | Naples | Italy |
| Research Site | Palermo | Italy |
| Research Site | Roma | Italy |
| Research Site | Siena | Italy |
| Research Site | Tradate | Italy |
| Research Site | Stockholm | Sweden |
| Research Site | Uppsala | Sweden |
| Research Site | Basel | Switzerland |
| Research Site | Chur | Switzerland |
| Research Site | Lugano | Switzerland |
| Research Site | Sion | Switzerland |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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