Clinical trial NCT05677139: A Study for Observing Severe Asthma in Patients Treated With Tezepelumab
Official title: Asthma Control in Severe Asthma Patients Treated With Tezepelumab: A Prospective, Observational, Real-World Evidence Study (ASCENT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Keywords: Real-World Evidence
Severe Uncontrolled Asthma
Inhaled corticosteroids (ICS)
Post-Authorization
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-01-10
Enrollment: 550
Sex: ALL
Minimum age (years): 12
Maximum age (years): 130
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Asthma Control Questionnaire (ACQ-6) score
timeFrame: Week 52
measure: Change in Asthma Control Questionnaire 6 (ACQ-6) score from Baseline
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Number of participants with improvement in ACQ-6 response score
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Number of participants with well-controlled asthma (ACQ-6 score ≤ 0.75)
timeFrame: Week 52
measure: Time to first ACQ-6 response
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
Secondary outcomes:
measure: St. George's Respiratory Questionnaire (SGRQ) total score
timeFrame: Week 52
measure: Asthma Control Test (ACT) total score
timeFrame: Week 52
measure: Change from baseline in SGRQ total score
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Change from baseline in ACT total score
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Number of participants with improvement in SGRQ total score
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Number of participants with improvement in ACT total score
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Pre-bronchodilator forced expiratory volume in 1 second (FEV1)
timeFrame: Week 52
measure: Post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
timeFrame: Week 52
measure: Pre BD forced vital capacity (FVC)
timeFrame: Week 52
measure: Post-BD FVC
timeFrame: Week 52
measure: Pre-BD forced expiratory flow (FEF)
timeFrame: Baseline (Week -52 to Week 0), Week 4, Week 24, and Week 52
measure: Changes from baseline in pre-BD FEF
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Changes from baseline in pre-BD FEV1
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Changes from baseline in post-BD FEV1
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Changes from baseline in pre-BD FVC
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Changes from baseline in post-BD FVC
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Proportion of participants with spirometry and/or body plethysmography parameters
timeFrame: Week 52
measure: Number of participants who achieve 5% or 100 mL improvement in pre-BD and post-BD FEV1
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Annualized asthma exacerbation rate (AAER)
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Proportion of participants with asthma exacerbations
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Proportion of participants with reduced total number of asthma exacerbations
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Proportion of participants who completed 52 weeks of tezepelumab treatment with at least 50% reduction in exacerbations
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Proportion of participants who completed 52 weeks of tezepelumab treatment without an asthma exacerbation
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Change from baseline in AAER
timeFrame: Baseline (Week -52 to Week 0) to Week 52
measure: Cumulative asthma exacerbation days
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Proportion of participants with any systemic corticosteroid (SCS) or inhaled corticosteroid (ICS) use
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Number of participants with categorised percent reduction on cumulative systemic corticosteroids (SCS) dose
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Median SCS or ICS dose change
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Proportion of participants with long-term SCS and ICS use
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Time to earliest use SCS from tezepelumab initiation among patients that used SCS or ICS
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Number and type of asthma related healthcare resource utilization (HCRU)
timeFrame: Baseline (Week -52 to Week 0), Week 4, Week 12, Week 24, and Week 52
measure: Annualized rates of asthma-related visits leading to hospitalization and emergency department (ED) visits, urgent care visits, or unscheduled out-patient or physician visits
timeFrame: Baseline (Week -52 to Week 0), Week 4, Week 12, Week 24, and Week 52
measure: Annualized rates of asthma related physician/healthcare calls/visits
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Duration of asthma-related hospitalisation
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Proportion of participants with stable disease
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Duration (days) of tezepelumab treatment
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Proportion of participants with tezepelumab discontinuation and reason(s)
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Proportion of participants with switching to other biologics for asthma and reasons(s)
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
measure: Time to tezepelumab discontinuation
timeFrame: From Baseline (Week -52 to Week 0) to Week 52
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Research Site
city: Klagenfurt Am W Rthersee
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Erpent
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Moeskroen
country: Belgium
facility: Research Site
city: Woluwe-Saint-Lambert
country: Belgium
facility: Research Site
city: Yvoir
country: Belgium
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Colombia
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Kingston
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Montr Al,
country: Canada
facility: Research Site
state: Qu Bec
city: Saskatoon
country: Canada
facility: Research Site
state: Saskatchewan
city: Copenhagen
country: Denmark
facility: Research Site
city: Hvidovre
country: Denmark
facility: Research Site
city: Vejle
country: Denmark
facility: Research Site
city: Aschaffenburg
country: Germany
facility: Research Site
city: Auerbach
country: Germany
facility: Research Site
city: Augsburg
country: Germany
facility: Research Site
city: Bamberg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Biberach An Der Ri
country: Germany
facility: Research Site
city: Bonn
country: Germany
facility: Research Site
city: Cottbus
country: Germany
facility: Research Site
city: Delitzsch
country: Germany
facility: Research Site
city: Dusseldorf
country: Germany
facility: Research Site
city: Dusseldorf
country: Germany
facility: Research Site
city: Flensburg
country: Germany
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Hanover
country: Germany
facility: Research Site
city: Heidelberg
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Markkleeberg
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Schleswig
country: Germany
facility: Research Site
city: Stuttgart
country: Germany
facility: Research Site
city: Teuchern
country: Germany
facility: Research Site
city: V Lklingen
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Rehovot
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Ancona
country: Italy
facility: Research Site
city: Bergamo
country: Italy
facility: Research Site
city: Catanzaro
country: Italy
facility: Research Site
city: Firenze
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Siena
country: Italy
facility: Research Site
city: Yradate
country: Italy
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Chur
country: Switzerland
facility: Research Site
city: Lugano
country: Switzerland
facility: Research Site
city: Sion
country: Switzerland
facility: Research Site
Study officials:
References: