A Study for Observing Severe Asthma in Patients Treated With Tezepelumab

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05677139
• Other study ID #: D5180R00011
• Status: Recruiting
• Start date: December 13, 2022
• Est. completion date: November 20, 2025

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: November 20, 2025
• Est. primary completion date: November 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 130 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• None (Observational Study)
Not applicable since it's an observational study.

Locations

Country	Name	City	State
Austria	Research Site	Innsbruck
Austria	Research Site	Klagenfurt Am Worthersee
Austria	Research Site	Wien
Austria	Research Site	Wien
Belgium	Research Site	Erpent
Belgium	Research Site	Gent
Belgium	Research Site	Leuven
Belgium	Research Site	Liege
Belgium	Research Site	Moeskroen
Belgium	Research Site	Woluwe Saint Lambert
Belgium	Research Site	Yvoir
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Kingston	Ontario
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Saskatoon	Saskatchewan
Canada	Research Site	St Johns	Newfoundland and Labrador
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Colombia
Canada	Research Site	Windsor	Ontario
Denmark	Research Site	Copenhagen
Denmark	Research Site	Hvidovre
Denmark	Research Site	Vejle
Germany	Research Site	Aschaffenburg
Germany	Research Site	Auerbach
Germany	Research Site	Augsburg
Germany	Research Site	Bamberg
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Biberach an der Riss
Germany	Research Site	Bonn
Germany	Research Site	Cottbus
Germany	Research Site	Delitzsch
Germany	Research Site	Dusseldorf
Germany	Research Site	Dusseldorf
Germany	Research Site	Flensburg
Germany	Research Site	Freiburg
Germany	Research Site	Hamburg
Germany	Research Site	Hamburg
Germany	Research Site	Hanover
Germany	Research Site	Heidelberg
Germany	Research Site	Leipzig
Germany	Research Site	Marburg
Germany	Research Site	Marburg
Germany	Research Site	Markkleeberg
Germany	Research Site	Munchen
Germany	Research Site	Schleswig
Germany	Research Site	Stuttgart
Germany	Research Site	Teuchern
Germany	Research Site	Volklingen
Germany	Research Site	Wiesbaden
Israel	Research Site	Jerusalem
Israel	Research Site	Rehovot
Israel	Research Site	Tel Aviv
Italy	Research Site	Ancona
Italy	Research Site	Bergamo
Italy	Research Site	Catanzaro
Italy	Research Site	Firenze
Italy	Research Site	Milano
Italy	Research Site	Napoli
Italy	Research Site	Padova
Italy	Research Site	Palermo
Italy	Research Site	Roma
Italy	Research Site	Siena
Italy	Research Site	Yradate
Sweden	Research Site	Stockholm
Sweden	Research Site	Uppsala
Switzerland	Research Site	Basel
Switzerland	Research Site	Chur
Switzerland	Research Site	Lugano
Switzerland	Research Site	Sion

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  Denmark,  Germany,  Israel,  Italy,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. ß2 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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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.	Week 52
Secondary	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
Secondary	Change from baseline in SGRQ total score	Asthma-specific HRQoL will be described.	From Baseline (Week -52 to Week 0) to Week 52
Secondary	Change from baseline in ACT total score	Asthma-specific HRQoL will be described.	From Baseline (Week -52 to Week 0) to Week 52
Secondary	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
Secondary	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
Secondary	Pre-bronchodilator forced expiratory volume in 1 second (FEV1)	Lung function will be described.	Week 52
Secondary	Post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)	Lung function will be described.	Week 52
Secondary	Pre BD forced vital capacity (FVC)	Lung function will be described.	Week 52
Secondary	Post-BD FVC	Lung function will be described.	Week 52
Secondary	Pre-BD forced expiratory flow (FEF)	Lung function will be described.	Baseline (Week -52 to Week 0), Week 4, Week 24, and Week 52
Secondary	Changes from baseline in pre-BD FEF	Lung function will be described.	From Baseline (Week -52 to Week 0) to Week 52
Secondary	Changes from baseline in pre-BD FEV1	Lung function will be described.	From Baseline (Week -52 to Week 0) to Week 52
Secondary	Changes from baseline in post-BD FEV1	Lung function will be described.	From Baseline (Week -52 to Week 0) to Week 52
Secondary	Changes from baseline in pre-BD FVC	Lung function will be described.	From Baseline (Week -52 to Week 0) to Week 52
Secondary	Changes from baseline in post-BD FVC	Lung function will be described	From Baseline (Week -52 to Week 0) to Week 52
Secondary	Proportion of participants with spirometry and/or body plethysmography parameters	Participants will be assessed through spirometry and body plethysmography parameters	Week 52
Secondary	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
Secondary	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
Secondary	Proportion of participants with asthma exacerbations	Asthma exacerbations will be described.	From Baseline (Week -52 to Week 0) to Week 52
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from baseline in AAER	Asthma exacerbations will be described.	Baseline (Week -52 to Week 0) to Week 52
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Duration of asthma-related hospitalisation	Asthma related HCRU will be described.	From Baseline (Week -52 to Week 0) to Week 52
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to tezepelumab discontinuation	Time taken to discontinue tezepelumab will be described.	From Baseline (Week -52 to Week 0) to Week 52