Back to resultsEffectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Asthma in the United States (PASSAGE)
Primary Purpose
Asthma
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tezepelumab
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Inhaled corticosteroids (ICS), Post-Authorization, Baseline Blood eosinophil count (BEC), long-acting- β2 Agonist (LABA), Real-world participant population
Eligibility Criteria
Inclusion Criteria:
- Male or female participant must be 12 years of age or older, at the time of signing the informed consent form or assent.
- Documented physician-diagnosed asthma for at least 12 months and confirmed by the Investigator not to be due to alternative diagnoses.
- Documented treatment with medium- to high dose ICS as per Global Initiative for Asthma (GINA) guidelines (GINA 2021) for at least 12 months.
- Use of additional asthma maintenance controller medication(s) in addition to ICS for at least 12 months. The additional maintenance controller medication may be contained in a combination product (eg, ICS/ long-acting β-agonist (LABA)).
- Documented history of at least 2 asthma exacerbations during the 12 months.
- Physician decision that participant is eligible for treatment with tezepelumab according to the approved United States product insert (USPI).
- Currently receiving care from specialist physicians (eg, pulmonologists and/or allergists).
- Completed the full course of COVID-19 vaccination at least 28 days prior to tezepelumab administration. Taking an approved vaccine booster is not a requirement to participate in this study.
- Provision of signed and dated written informed consent form.
Exclusion Criteria:
- Any contraindication to tezepelumab as per the US approved product label or in the opinion of the Investigator.
- Comorbid diagnosis of severe or very severe chronic obstructive pulmonary disease (COPD) per GOLD guidelines (GOLD 2021).
- Prior biologic use for the treatment of asthma within 4 months or 5 half-lives (whichever is longer).
- Participation in an interventional clinical trial for asthma within 12 months.
- Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
Sites / Locations
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Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tezepelumab
Arm Description
Participants will be receiving 210 mg of tezepelumab every 4 weeks (Q4W) from Week 0 until Week 48.
Outcomes
Primary Outcome Measures
Annualized asthma exacerbation rate (AAER)
Asthma exacerbation will be defined by worsening of asthma symptoms that leads to temporary bolus/burst of systemic corticosteroids for at least 3 consecutive days, or an emergency department (ED) or urgent care visit due to asthma that required systemic corticosteroid (SCS), and/or inpatient hospitalization (≥24 hours) due to asthma. The AAER is based on exacerbations reported by the investigator over 52 weeks.
The exacerbation rate will be compared between the 12 month period before (baseline period) and the 12 month period after initiation of tezepelumab (up to study Week 52 - study period).
Proportion of participants with asthma exacerbations
The proportion of participants with asthma exacerbations in the 12 month periods before (baseline period) and after initiation of tezepelumab (study period) (up to study Week 52 - study period) will be assessed.
Proportion of participants who completed the 52 -week study period with any reduction in total number of asthma exacerbations
The proportion of participants who completed the 52 -week study period following tezepelumab initiation with any reduction, at least 50% reduction, and 100% reduction in total number of asthma exacerbations will be assessed.
Cumulative asthma exacerbation days
The cumulative asthma exacerbation days over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed.
Secondary Outcome Measures
Time to first asthma exacerbation
The time to first exacerbation after initiation of tezepelumab will be assessed.
Rate of asthma exacerbations associated with hospitalizations
The rate of asthma exacerbations associated with hospitalization over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed.
Rate of asthma exacerbations associated with emergency department /urgent care (ED/UC) visits
The rate of asthma exacerbations associated with ED/UC visits over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed.
Rate of asthma exacerbations associated with hospitalizations or ED/UC visits over
The rate of asthma exacerbations associated with hospitalizations or ED/UC visits over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed.
Proportion of participants with asthma exacerbations associated with hospitalizations or ED/UC visits
The proportion of participants with asthma exacerbations associated with hospitalizations or ED/UC visits in in the 12-month periods before (baseline period) and after initiation of tezepelumab (study period) (up to study Week 52) will be assessed.
Cumulative asthma exacerbation days associated with hospitalizations or ED/UC visits
The cumulative asthma exacerbation days associated with hospitalizations or ED/UC over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed.
Pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)
Lung function (FEV1) will be measured pre-bronchodilator (pre-BD) by spirometry test.
Change from baseline in pre-bronchodilator FEV1
Change from baseline in pre-bronchodilator FEV1 will be assessed as lung function parameters after initiation of tezepelumab.
Proportion of pre-BD FEV1 responders
Proportion of pre-BD FEV1 responders is defined as participants who achieve either at least 5% or 100 mL improvement from baseline.
Asthma Control Questionnaire (ACQ-6)
The ACQ-6 is a shortened version of the ACQ that assesses the adequacy of asthma control and change in asthma control which occurs spontaneously or as a result of treatment. ACQ assesses symptoms and rescue bronchodilator use.
Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score is the mean of the responses.
Asthma Impairment and Risk Questionnaire (AIRQ)
The Asthma Impairment and Risk Questionnaire (AIRQ) is a PRO tool intended to identify participants 12 years and older whose health may be at risk because of uncontrolled asthma.
It has 10 questions that ask about respiratory symptoms, activity limitation, sleep, rescue medication use, social activities, exercise, difficulty controlling asthma, and exacerbations. All items have a yes/no response option and the tool is scored by summing the total number of 'yes' responses. This sum score is used to assess level of asthma control where: 0-1 is well controlled, 2-4 is not well controlled, and 5-10 is very poorly controlled. Thus, a higher score indicates worse control status.
St. George's Respiratory Questionnaire (SGRQ)
The SGRQ is a 50-item PRO instrument developed to measure the health status of participants with airway obstruction diseases.
The questionnaire is divided into 2 parts: part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ yields a total score and 3 components scores (symptoms, activity, and impacts). 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. Likewise, the domain scores range from 0 to 100, with higher scores indicative of greater impairment.
Change from baseline in ACQ-6 score
Change from baseline in ACQ-6 score will be assessed.
Change from baseline in AIRQ score
Change from baseline in AIRQ score will be assessed.
Change from baseline in SGRQ score
Change from baseline in SGRQ score will be assessed.
Proportion of ACQ-6 responders
ACQ-6 responders are defined as participants who achieve >=1 clinically important difference (MCID).
Proportion of AIRQ responders
AIRQ responders is defined as participants who achieve ≥1 minimum clinically important difference (MCID).
Proportion of SGRQ responders
SGRQ responders is defined as participants who achieve ≥1 minimum clinically important difference (MCID).
Proportion of participants who require any systemic corticosteroid (SCS) use
Proportion of participants who require any SCS use in the 12-month periods before (baseline period) and after initiation of tezepelumab (up to study Week 52 -study period) will be assessed.
Cumulative annualized SCS dose
Cumulative annualized SCS dose in the 12-month periods before (baseline period) and after initiation of tezepelumab (up to study Week 52- study period) will be assessed.
Proportion of participants who require longer-term (>30 consecutive days) SCS use
Proportion of participants who require longer-term (>30 consecutive days) SCS use in the 12-month periods before (baseline period) and after initiation of tezepelumab (up to study Week 52- study period) will be assessed.
Number and type of asthma-related healthcare resource utilization (HRU)
Number and type of asthma-related HRU in the 12-month period before (baseline period) and after initiation of tezepelumab (up to study Week 52- study period) will be assessed.
Duration of asthma-related hospitalizations
Duration of asthma-related hospitalization in the 12-month period before (baseline period) and after initiation of tezepelumab (up to study Week 52-study period) will be assessed.
AAER for asthma exacerbations (subgroups of participants)
The AAER based on asthma exacerbations in the 12-month period before (baseline period) and after initiation of tezepelumab (up to study Week 52- study period) will be assessed in the following subgroups of participants: Blood eosinophil count (BEC) ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking).
Proportion of participants with asthma exacerbations (subgroups of participants)
The proportion of participants with asthma exacerbations in the 12-month period before (baseline period) and after initiation of tezepelumab (up to study Week 52- study period) will be assessed in the following subgroups of participants: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking).
Proportion of participants who completed the 52 -week study with any reduction in total number of asthma exacerbations (subgroups of participants)
The proportion of participants who completed the 52 -week study period following tezepelumab initiation with any reduction, at least 50% reduction, and 100% reduction in total number of asthma exacerbations will be assessed in the following subgroups of participants: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking).
Cumulative asthma exacerbation days (subgroups of participants)
The cumulative asthma exacerbation days over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed in the following subgroups of participants: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking).
Rate of asthma exacerbations associated with hospitalizations (subgroups of participants)
The rate of asthma exacerbations associated with hospitalization over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed in the following subgroups of participants: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking).
Rate of asthma exacerbations associated with emergency department urgent care (ED/UC) visits (subgroups of participants)
The rate of asthma exacerbations associated with ED/UC visits over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed in the following subgroups of participants: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking).
Rate of asthma exacerbations associated with hospitalizations or ED/UC visits over (subgroups of participants)
The rate of asthma exacerbations associated with hospitalizations or ED/UC visits over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed in the following subgroups of participants: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking).
Number and type of asthma-related HRU (subgroups of participants)
Number and type of asthma related HRU in the 12-month period before (baseline period) and after initiation of tezepelumab (up to study Week 52- study period) will be assessed in the following subgroups of participants: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking).
Duration of asthma-related hospitalizations (subgroups of participants)
Duration of asthma-related hospitalization in the 12- month period before (baseline period) and after initiation of tezepelumab (up to study Week 52- study period) will be assessed in the following subgroups of participants: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking).
Full Information
NCT ID
NCT05329194
First Posted
March 17, 2022
Last Updated
October 9, 2023
Sponsor
AstraZeneca
Collaborators
Parexel
1. Study Identification
Unique Protocol Identification Number
NCT05329194
Brief Title
Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Asthma in the United States
Acronym
PASSAGE
Official Title
A Multicenter, Single-arm, Open-label, Post-Authorization, Phase 4 Effectiveness and Safety Study of Tezepelumab in Adult and Adolescent Participants With Severe Asthma Including Several Under-Studied Populations in the United States (PASSAGE)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2022 (Actual)
Primary Completion Date
July 8, 2025 (Anticipated)
Study Completion Date
July 8, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
Parexel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To asses effectiveness and safety of tezepelumab in adult and adolescent participants with severe asthma including several under-studied populations in the United States.
Detailed Description
This is a multicenter, single-arm, open-label, Post-authorization, Phase 4 study to assess the effectiveness of tezepelumab in the United States (US) among a real-world population of adults and adolescent participants with asthma requiring medium-dose to high-dose inhaled corticosteroids (ICS), with additional controller(s) for at least 12 months with documented history of at least 2 asthma exacerbations during the year prior to enrolment. The total duration of the study for each participant will be approximately 56 weeks. Approximately 400 participants will be enrolled. Participants will receive tezepelumab via subcutaneous injection at the study site, over a 48-week treatment period. The study also includes a post-dosing follow-up period from Weeks 48 to 52.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Inhaled corticosteroids (ICS), Post-Authorization, Baseline Blood eosinophil count (BEC), long-acting- β2 Agonist (LABA), Real-world participant population
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tezepelumab
Arm Type
Experimental
Arm Description
Participants will be receiving 210 mg of tezepelumab every 4 weeks (Q4W) from Week 0 until Week 48.
Intervention Type
Drug
Intervention Name(s)
Tezepelumab
Other Intervention Name(s)
AMG 157 or MEDI9929
Intervention Description
Participants will be receiving subcutaneous injection of tezepelumab.
Primary Outcome Measure Information:
Title
Annualized asthma exacerbation rate (AAER)
Description
Asthma exacerbation will be defined by worsening of asthma symptoms that leads to temporary bolus/burst of systemic corticosteroids for at least 3 consecutive days, or an emergency department (ED) or urgent care visit due to asthma that required systemic corticosteroid (SCS), and/or inpatient hospitalization (≥24 hours) due to asthma. The AAER is based on exacerbations reported by the investigator over 52 weeks.
The exacerbation rate will be compared between the 12 month period before (baseline period) and the 12 month period after initiation of tezepelumab (up to study Week 52 - study period).
Time Frame
Baseline period up to study Week 52
Title
Proportion of participants with asthma exacerbations
Description
The proportion of participants with asthma exacerbations in the 12 month periods before (baseline period) and after initiation of tezepelumab (study period) (up to study Week 52 - study period) will be assessed.
Time Frame
Baseline period up to study Week 52
Title
Proportion of participants who completed the 52 -week study period with any reduction in total number of asthma exacerbations
Description
The proportion of participants who completed the 52 -week study period following tezepelumab initiation with any reduction, at least 50% reduction, and 100% reduction in total number of asthma exacerbations will be assessed.
Time Frame
Baseline period up to study Week 52
Title
Cumulative asthma exacerbation days
Description
The cumulative asthma exacerbation days over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed.
Time Frame
Baseline period up to study Week 52
Secondary Outcome Measure Information:
Title
Time to first asthma exacerbation
Description
The time to first exacerbation after initiation of tezepelumab will be assessed.
Time Frame
Week 0 to Week 52
Title
Rate of asthma exacerbations associated with hospitalizations
Description
The rate of asthma exacerbations associated with hospitalization over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed.
Time Frame
Baseline period up to study Week 52
Title
Rate of asthma exacerbations associated with emergency department /urgent care (ED/UC) visits
Description
The rate of asthma exacerbations associated with ED/UC visits over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed.
Time Frame
Baseline period up to study Week 52
Title
Rate of asthma exacerbations associated with hospitalizations or ED/UC visits over
Description
The rate of asthma exacerbations associated with hospitalizations or ED/UC visits over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed.
Time Frame
Baseline period up to study Week 52
Title
Proportion of participants with asthma exacerbations associated with hospitalizations or ED/UC visits
Description
The proportion of participants with asthma exacerbations associated with hospitalizations or ED/UC visits in in the 12-month periods before (baseline period) and after initiation of tezepelumab (study period) (up to study Week 52) will be assessed.
Time Frame
Baseline period up to study Week 52
Title
Cumulative asthma exacerbation days associated with hospitalizations or ED/UC visits
Description
The cumulative asthma exacerbation days associated with hospitalizations or ED/UC over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed.
Time Frame
Baseline period up to study Week 52
Title
Pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)
Description
Lung function (FEV1) will be measured pre-bronchodilator (pre-BD) by spirometry test.
Time Frame
Baseline (Week 0), Week 24, Week 52
Title
Change from baseline in pre-bronchodilator FEV1
Description
Change from baseline in pre-bronchodilator FEV1 will be assessed as lung function parameters after initiation of tezepelumab.
Time Frame
Baseline (Week 0), Week 24, Week 52
Title
Proportion of pre-BD FEV1 responders
Description
Proportion of pre-BD FEV1 responders is defined as participants who achieve either at least 5% or 100 mL improvement from baseline.
Time Frame
Baseline (Week 0), Week 24, Week 52
Title
Asthma Control Questionnaire (ACQ-6)
Description
The ACQ-6 is a shortened version of the ACQ that assesses the adequacy of asthma control and change in asthma control which occurs spontaneously or as a result of treatment. ACQ assesses symptoms and rescue bronchodilator use.
Questions are weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ-6 score is the mean of the responses.
Time Frame
Baseline (Week 0), Week 24, Week 52
Title
Asthma Impairment and Risk Questionnaire (AIRQ)
Description
The Asthma Impairment and Risk Questionnaire (AIRQ) is a PRO tool intended to identify participants 12 years and older whose health may be at risk because of uncontrolled asthma.
It has 10 questions that ask about respiratory symptoms, activity limitation, sleep, rescue medication use, social activities, exercise, difficulty controlling asthma, and exacerbations. All items have a yes/no response option and the tool is scored by summing the total number of 'yes' responses. This sum score is used to assess level of asthma control where: 0-1 is well controlled, 2-4 is not well controlled, and 5-10 is very poorly controlled. Thus, a higher score indicates worse control status.
Time Frame
Baseline (Week 0), Week 24, Week 52
Title
St. George's Respiratory Questionnaire (SGRQ)
Description
The SGRQ is a 50-item PRO instrument developed to measure the health status of participants with airway obstruction diseases.
The questionnaire is divided into 2 parts: part 1 consists of 8 items pertaining to the severity of respiratory symptoms in the preceding 4 weeks; part 2 consists of 42 items related to the daily activity and psychosocial impacts of the individual's respiratory condition. The SGRQ yields a total score and 3 components scores (symptoms, activity, and impacts). 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. Likewise, the domain scores range from 0 to 100, with higher scores indicative of greater impairment.
Time Frame
Baseline (Week 0), Week 24, Week 52
Title
Change from baseline in ACQ-6 score
Description
Change from baseline in ACQ-6 score will be assessed.
Time Frame
Baseline (Week 0), Week 24, Week 52
Title
Change from baseline in AIRQ score
Description
Change from baseline in AIRQ score will be assessed.
Time Frame
Baseline (Week 0), Week 24, Week 52
Title
Change from baseline in SGRQ score
Description
Change from baseline in SGRQ score will be assessed.
Time Frame
Baseline (Week 0), Week 24, Week 52
Title
Proportion of ACQ-6 responders
Description
ACQ-6 responders are defined as participants who achieve >=1 clinically important difference (MCID).
Time Frame
Baseline (Week 0), Week 24, Week 52
Title
Proportion of AIRQ responders
Description
AIRQ responders is defined as participants who achieve ≥1 minimum clinically important difference (MCID).
Time Frame
Baseline (Week 0), Week 24, Week 52
Title
Proportion of SGRQ responders
Description
SGRQ responders is defined as participants who achieve ≥1 minimum clinically important difference (MCID).
Time Frame
Baseline (Week 0), Week 24, Week 52
Title
Proportion of participants who require any systemic corticosteroid (SCS) use
Description
Proportion of participants who require any SCS use in the 12-month periods before (baseline period) and after initiation of tezepelumab (up to study Week 52 -study period) will be assessed.
Time Frame
Baseline period up to study Week 52
Title
Cumulative annualized SCS dose
Description
Cumulative annualized SCS dose in the 12-month periods before (baseline period) and after initiation of tezepelumab (up to study Week 52- study period) will be assessed.
Time Frame
Baseline period up to study Week 52
Title
Proportion of participants who require longer-term (>30 consecutive days) SCS use
Description
Proportion of participants who require longer-term (>30 consecutive days) SCS use in the 12-month periods before (baseline period) and after initiation of tezepelumab (up to study Week 52- study period) will be assessed.
Time Frame
Baseline period up to study Week 52
Title
Number and type of asthma-related healthcare resource utilization (HRU)
Description
Number and type of asthma-related HRU in the 12-month period before (baseline period) and after initiation of tezepelumab (up to study Week 52- study period) will be assessed.
Time Frame
Baseline period up to study Week 52
Title
Duration of asthma-related hospitalizations
Description
Duration of asthma-related hospitalization in the 12-month period before (baseline period) and after initiation of tezepelumab (up to study Week 52-study period) will be assessed.
Time Frame
Baseline period up to study Week 52
Title
AAER for asthma exacerbations (subgroups of participants)
Description
The AAER based on asthma exacerbations in the 12-month period before (baseline period) and after initiation of tezepelumab (up to study Week 52- study period) will be assessed in the following subgroups of participants: Blood eosinophil count (BEC) ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking).
Time Frame
Baseline period up to study Week 52
Title
Proportion of participants with asthma exacerbations (subgroups of participants)
Description
The proportion of participants with asthma exacerbations in the 12-month period before (baseline period) and after initiation of tezepelumab (up to study Week 52- study period) will be assessed in the following subgroups of participants: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking).
Time Frame
Baseline period up to study Week 52
Title
Proportion of participants who completed the 52 -week study with any reduction in total number of asthma exacerbations (subgroups of participants)
Description
The proportion of participants who completed the 52 -week study period following tezepelumab initiation with any reduction, at least 50% reduction, and 100% reduction in total number of asthma exacerbations will be assessed in the following subgroups of participants: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking).
Time Frame
Week 0 to Week 52
Title
Cumulative asthma exacerbation days (subgroups of participants)
Description
The cumulative asthma exacerbation days over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed in the following subgroups of participants: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking).
Time Frame
Baseline period up to study Week 52
Title
Rate of asthma exacerbations associated with hospitalizations (subgroups of participants)
Description
The rate of asthma exacerbations associated with hospitalization over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed in the following subgroups of participants: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking).
Time Frame
Baseline period up to study Week 52
Title
Rate of asthma exacerbations associated with emergency department urgent care (ED/UC) visits (subgroups of participants)
Description
The rate of asthma exacerbations associated with ED/UC visits over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed in the following subgroups of participants: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking).
Time Frame
Baseline period up to study Week 52
Title
Rate of asthma exacerbations associated with hospitalizations or ED/UC visits over (subgroups of participants)
Description
The rate of asthma exacerbations associated with hospitalizations or ED/UC visits over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) will be assessed in the following subgroups of participants: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking).
Time Frame
Baseline period up to study Week 52
Title
Number and type of asthma-related HRU (subgroups of participants)
Description
Number and type of asthma related HRU in the 12-month period before (baseline period) and after initiation of tezepelumab (up to study Week 52- study period) will be assessed in the following subgroups of participants: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking).
Time Frame
Baseline period up to study Week 52
Title
Duration of asthma-related hospitalizations (subgroups of participants)
Description
Duration of asthma-related hospitalization in the 12- month period before (baseline period) and after initiation of tezepelumab (up to study Week 52- study period) will be assessed in the following subgroups of participants: BEC ≥300 cells/microliter; BEC <300 cells/microliter; With a clinically-relevant allergy to a perennial aeroallergen; Without a clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate COPD; Significant smoking history (≥10 pack-years of smoking).
Time Frame
Baseline period up to study Week 52
Other Pre-specified Outcome Measures:
Title
Number of participants with serious adverse events, adverse events that lead to tezepelumab treatment discontinuation, and adverse events of special interest
Description
The safety and tolerability of tezepelumab will be assessed.
Time Frame
Week 0 to Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female participant must be 12 years of age or older, at the time of signing the informed consent form or assent.
Documented physician-diagnosed asthma for at least 12 months prior to enrollment and confirmed by the Investigator not to be due to alternative diagnoses.
Documented treatment with medium- to high dose ICS as per Global Initiative for Asthma (GINA) guidelines (GINA 2021) for at least 12 months prior to enrollment.
Use of additional asthma maintenance controller medication(s) in addition to ICS for at least 12 months prior to enrollment. The additional maintenance controller medication may be contained in a combination product (eg, ICS/ long-acting β-agonist (LABA)).
Documented history of at least 2 asthma exacerbations during the 12 months prior to enrollment.
Physician decision that participant is eligible for treatment with tezepelumab according to the approved United States product insert (USPI).
Currently receiving care from specialist physicians (eg, pulmonologists and/or allergists).
Provision of signed and dated written informed consent form.
Exclusion Criteria:
Any contraindication to tezepelumab as per the US approved product label or in the opinion of the Investigator.
Comorbid diagnosis of severe or very severe chronic obstructive pulmonary disease (COPD) per GOLD guidelines (GOLD 2021).
Use of biologics that are approved for the treatment of asthma within 4 months or 5 half- lives (whichever is longer) prior to enrollment.
Participation in an interventional clinical trial for asthma within 12 months prior to enrollment.
Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Njira Lugogo., MD.
Organizational Affiliation
University of Michigan Health. Michigan, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90815
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Upper Marlboro
State/Province
Maryland
ZIP/Postal Code
20772
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68505
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10465
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Hollis
State/Province
New York
ZIP/Postal Code
11423
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Horseheads
State/Province
New York
ZIP/Postal Code
14845
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27709
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Withdrawn
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests 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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified 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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
Effectiveness and Safety Study of Tezepelumab in Adults & Adolescent Participants With Severe Asthma in the United States
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