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Effektivitets- og sikkerhedsundersøgelse af Tezepelumab hos voksne og unge deltagere med svær astma i USA (PASSAGE)

15. juli 2026 opdateret af: AstraZeneca

En multicenter-, enkeltarms-, åben-label, post-godkendelses-, fase 4-effektivitets- og sikkerhedsundersøgelse af Tezepelumab hos voksne og unge deltagere med svær astma, herunder adskillige understuderede populationer i USA (PASSAGE)

At vurdere effektiviteten og sikkerheden af ​​tezepelumab hos voksne og unge deltagere med svær astma, herunder flere undersøgte populationer i USA.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette er et multicenter, enkeltarms, åbent, post-godkendelsesfase 4-studie for at vurdere effektiviteten af ​​tezepelumab i USA (USA) blandt en virkelig verden af ​​voksne og unge deltagere med astma, der kræver middeldosis til højdosis inhalerede kortikosteroider (ICS), med yderligere controller(er) i mindst 12 måneder med dokumenteret anamnese med mindst 2 astma-eksacerbationer i løbet af året. Den samlede varighed af undersøgelsen for hver deltager vil være cirka 56 uger. Der vil blive tilmeldt cirka 400 deltagere. Deltagerne vil modtage tezepelumab via subkutan injektion på undersøgelsesstedet over en 48-ugers behandlingsperiode. Undersøgelsen inkluderer også en opfølgningsperiode efter dosering fra uge 48 til 52.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

286

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Mobile, Alabama, Forenede Stater, 36608
        • Research Site
    • Arizona
      • Gilbert, Arizona, Forenede Stater, 85234
        • Research Site
    • California
      • Long Beach, California, Forenede Stater, 90815
        • Research Site
      • Los Angeles, California, Forenede Stater, 90017
        • Research Site
      • Rancho Mirage, California, Forenede Stater, 92270
        • Research Site
      • Westminster, California, Forenede Stater, 92683
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • Research Site
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06510
        • Research Site
    • District of Columbia
      • Washington D.C., District of Columbia, Forenede Stater, 20037
        • Research Site
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Research Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40509
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Research Site
    • Maryland
      • Upper Marlboro, Maryland, Forenede Stater, 20772
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • Research Site
      • Ypsilanti, Michigan, Forenede Stater, 48197
        • Research Site
    • Minnesota
      • Saint Paul, Minnesota, Forenede Stater, 55109
        • Research Site
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Research Site
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68505
        • Research Site
      • Omaha, Nebraska, Forenede Stater, 68114
        • Research Site
    • New York
      • Hollis, New York, Forenede Stater, 11423
        • Research Site
      • Horseheads, New York, Forenede Stater, 14845
        • Research Site
      • Rochester, New York, Forenede Stater, 14642
        • Research Site
      • Valhalla, New York, Forenede Stater, 10595
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27514
        • Research Site
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Research Site
    • Ohio
      • Toledo, Ohio, Forenede Stater, 43617
        • Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • Research Site
    • Pennsylvania
      • Altoona, Pennsylvania, Forenede Stater, 16602
        • Research Site
      • Philadelphia, Pennsylvania, Forenede Stater, 19140
        • Research Site
    • Rhode Island
      • Warwick, Rhode Island, Forenede Stater, 02886
        • Research Site
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29607
        • Research Site
    • Tennessee
      • Hendersonville, Tennessee, Forenede Stater, 37075
        • Research Site
    • Texas
      • Fort Worth, Texas, Forenede Stater, 76104
        • Research Site
      • McKinney, Texas, Forenede Stater, 75069
        • Research Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Research Site
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22903
        • Research Site
    • Washington
      • Vancouver, Washington, Forenede Stater, 98664
        • Research Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 130 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Mandlige eller kvindelige deltagere skal være 12 år eller ældre på tidspunktet for underskrivelsen af ​​den informerede samtykkeerklæring eller samtykke.
  • Dokumenteret lægediagnosticeret astma i mindst 12 måneder og bekræftet af investigator ikke at skyldes alternative diagnoser.
  • Dokumenteret behandling med middel til høj dosis ICS i henhold til Global Initiative for Astma (GINA) retningslinjer (GINA 2021) i mindst 12 måneder.
  • Brug af yderligere astmavedligeholdelseskontrolmedicin(er) ud over ICS i mindst 12 måneder. Den ekstra vedligeholdelseskontrolmedicin kan være indeholdt i et kombinationsprodukt (f.eks. ICS/langtidsvirkende β-agonist (LABA)).
  • Dokumenteret anamnese med mindst 2 astmaeksacerbationer i løbet af de 12 måneder.
  • Lægens beslutning om, at deltageren er berettiget til behandling med tezepelumab i henhold til den godkendte amerikansk produktindlæg (USPI).
  • Modtager i øjeblikket pleje fra speciallæger (f.eks. lungelæger og/eller allergiker).
  • Fuldførte hele COVID-19-vaccinationsforløbet mindst 28 dage før administration af tezepelumab. At tage en godkendt vaccinebooster er ikke et krav for at deltage i denne undersøgelse.
  • Udlevering af underskrevet og dateret skriftlig informeret samtykkeerklæring.

Ekskluderingskriterier:

  • Enhver kontraindikation for tezepelumab i henhold til den amerikansk godkendte produktetikette eller efter undersøgelsens mening.
  • Comorbid diagnose af svær eller meget svær kronisk obstruktiv lungesygdom (KOL) i henhold til GOLD-retningslinjerne (GOLD 2021).
  • Tidligere biologisk brug til behandling af astma inden for 4 måneder eller 5 halveringstider (alt efter hvad der er længst).
  • Deltagelse i et interventionelt klinisk forsøg for astma inden for 12 måneder.
  • Efterforskerens vurdering af, at det er usandsynligt, at deltageren overholder undersøgelsesprocedurer, begrænsninger og krav.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Tezepelumab
Deltagerne vil modtage 210 mg tezepelumab hver 4. uge (Q4W) fra uge 0 til uge 48.
Medicin: Tezepelumab
Deltagerne vil modtage subkutan injektion af tezepelumab.
Andre navne:
  • AMG 157 eller MEDI9929

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Annualized Asthma Exacerbation Rate (AAER)
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

Asthma exacerbations were 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 was based on exacerbations reported by the investigator over 52 weeks.

The exacerbation rate was compared between the 12-month period before [baseline period (BP)] and the 12-month period after initiation of tezepelumab [up to study Week 52 (Visit 15) = study period (SP)].
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Asthma Exacerbations
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
The number of participants with at least one asthma exacerbation in the 12-month period before (baseline period) and after initiation of tezepelumab (study period) (up to study Week 52 = study period) were assessed.
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Number of Participants Who Completed the 52 -Week Study Period With Any Reduction in Total Number of Asthma Exacerbations
Tidsramme: From Baseline period (Week -52 to Week 0) to Study period (Week 0 to Week 52)
The number of participants who completed the 52 -week study period following tezepelumab initiation with at least 50% reduction, and 100% reduction in total number of asthma exacerbations were assessed.
From Baseline period (Week -52 to Week 0) to Study period (Week 0 to Week 52)
Cumulative Asthma Exacerbation Days
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
The cumulative asthma exacerbation days over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) was assessed.
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Time to First Asthma Exacerbation
Tidsramme: Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)
The time to first exacerbation after initiation of tezepelumab was assessed. Data for median time to event have been presented for this endpoint. The median is the descriptive statistics median calculated using a subset of Participants with an event.
Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)
Rate of Asthma Exacerbations Associated With Hospitalizations
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
The rate of asthma exacerbations associated with hospitalization over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) was assessed.
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Rate of Asthma Exacerbations Associated With Emergency Department /Urgent Care (ED/UC) Visits
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
The rate of asthma exacerbations associated with ED/UC visits over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) was assessed.
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Rate of Asthma Exacerbations Associated With Hospitalizations or ED/UC Visits
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
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) was assessed.
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Number of Participants With Asthma Exacerbations Associated With Hospitalizations or ED/UC Visits
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
The number 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 = study period) were assessed.
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Cumulative Asthma Exacerbation Days Associated With Hospitalizations or ED/UC Visits
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

The cumulative asthma exacerbation days associated with hospitalizations or ED/UC over 52 weeks before (baseline period) and after initiation of tezepelumab (study period) were assessed.

Total days of exacerbations resulting in hospitalizations or ED/UC visits have been presented.
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1)
Tidsramme: Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Lung function (FEV1) was measured pre-bronchodilator (pre-BD) by spirometry test. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Change From Baseline in Pre-bronchodilator FEV1
Tidsramme: Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)
Change from baseline in pre-bronchodilator FEV1 was assessed after initiation of tezepelumab. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration.
Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)
Number of Pre-BD FEV1 Responders
Tidsramme: Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Number of pre-BD FEV1 responders was defined as participants who achieved either at least 5% or 100 mL improvement from baseline.
Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Asthma Control Questionnaire (ACQ-6)
Tidsramme: Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
The Asthma Control Questionnaire-6 (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), with higher scores indicating worse asthma control. The mean (average) ACQ-6 score is the mean of the responses.
Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Asthma Impairment and Risk Questionnaire (AIRQ)
Tidsramme: Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
The Asthma Impairment and Risk Questionnaire (AIRQ) is a Patient Reported Outcome (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, ranging from 0 to 10, with higher scores indicating worse asthma control, where: 0-1 is well controlled, 2-4 is not well controlled, and 5-10 is very poorly controlled.
Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
St. George's Respiratory Questionnaire (SGRQ)
Tidsramme: Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
St. George's Respiratory Questionnaire (SGRQ) is a 50-item Patient Reported Outcome (PRO) instrument used to measure health status of participants with airway obstruction diseases. Questionnaire has 2 parts: part 1 consists of 8 items pertaining to severity of respiratory symptoms in preceding 4 weeks; part 2 consists of 42 items related to daily activity and psychosocial impacts of individual's respiratory condition. SGRQ yields a total score and 3 components scores (symptoms, activity, and impacts). Total score indicates impact of disease on overall health status, and it is expressed as percentage of overall impairment, in which 100 represents worst possible health status and 0 indicates best possible health status. Likewise, domain scores range from 0 to 100, with higher scores indicative of greater impairment.
Baseline (Week 0), Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Change From Baseline in ACQ-6 Score
Tidsramme: Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)

Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) score was assessed.

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), with higher scores indicating worse asthma control.
Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)
Change From Baseline in AIRQ Score
Tidsramme: Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)
Change from baseline in Asthma Impairment and Risk Questionnaire (AIRQ) score was assessed. AIRQ is a Patient Reported Outcome (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, ranging from 0 to 10, with higher scores indicating worse asthma control, where: 0-1 is well controlled, 2-4 is not well controlled, and 5-10 is very poorly controlled.
Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)
Change From Baseline in SGRQ Score
Tidsramme: Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) score was assessed. SGRQ is a 50-item Patient Reported Outcome (PRO) instrument used to measure health status of participants with airway obstruction diseases. Questionnaire has 2 parts: part 1 consists of 8 items pertaining to severity of respiratory symptoms in preceding 4 weeks; part 2 consists of 42 items related to daily activity and psychosocial impacts of individual's respiratory condition. SGRQ yields a total score and 3 components scores (symptoms, activity, and impacts). Total score indicates impact of disease on overall health status, and it is expressed as percentage of overall impairment, in which 100 represents worst possible health status and 0 indicates best possible health status. Likewise, domain scores range from 0 to 100, with higher scores indicative of greater impairment.
Baseline (Week 0) to Week 24 (Visit 8 = 6 months) and Week 52 (Visit 15 = 12 months)
Number of ACQ-6 Responders
Tidsramme: Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Number of ACQ-6 responders were assessed. Individual changes from baseline of ≥ 0.5 were considered to be clinically meaningful (minimum clinically important difference [MCID]). ACQ-6 responders in this study were defined as participants who achieved ≥ 1 MCID.
Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Number of AIRQ Responders
Tidsramme: Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Number of AIRQ responders were assessed. Individual changes from baseline of ≥ 2 were considered to be clinically meaningful (MCID). AIRQ responders in this study were defined as participants who achieved ≥ 1 MCID.
Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Number of SGRQ Responders
Tidsramme: Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Number of SGRQ responders were assessed. Individual changes from baseline of ≥ 4 were considered to be clinically meaningful (MCID). SGRQ (total and component score) responders in this study were defined as participants who achieved ≥ 1 MCID.
Week 24 (Visit 8 = 6 months), Week 52 (Visit 15 = 12 months)
Number of Participants Who Require Any Systemic Corticosteroid (SCS) Use
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Number 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) were assessed.
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Cumulative Annualized SCS Dose
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

Cumulative annualized SCS dose in the 12-month periods before (baseline period) and after initiation of tezepelumab (up to study Week 52 = study period) were assessed. Cumulative annualized SCS dose for each participant was calculated as followed:

Cumulative annualized SCS dose = [sum of (cumulative SCS dose)/length of the planned treatment period]*365.25
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Number of Participants Who Require Longer-term (>30 Consecutive Days) SCS Use
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Number 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) were assessed.
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Number and Type of Asthma-related Healthcare Resource Utilization (HRU)
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Number of participants with specific 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) were assessed.
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Duration of Asthma-related Hospitalizations
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
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) was assessed.
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
AAER for Asthma Exacerbations (Subgroups of Participants)
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
AAER based on asthma exacerbations in the 12-month period before [baseline period (BP)] and after initiation of tezepelumab [up to study Week 52 = study period (SP)] was assessed in following subgroups of participants: Blood eosinophil count (BEC) ≥300 cells/microliter; BEC <300 cells/microliter; With clinically-relevant allergy to perennial aeroallergen; Without clinically-relevant allergy to a perennial aeroallergen; Participants who identify as Black/African American; Adolescents (12-17 years); Comorbid diagnosis of mild to moderate chronic obstructive pulmonary disease (COPD); Significant smoking history (≥10 pack-years of smoking).
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Number of Participants With Asthma Exacerbations (Subgroups of Participants)
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
The number of participants with at least one asthma exacerbations in the 12-month period before [baseline period (BP)] and after initiation of tezepelumab [up to study Week 52 = study period (SP)] were 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).
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Number of Participants Who Completed the 52-week Study With Any Reduction in Total Number of Asthma Exacerbations (Subgroups of Participants)
Tidsramme: From Baseline period (Week -52 to Week 0) to Study period (Week 0 to Week 52)
The number of participants who completed the 52-week study period following tezepelumab initiation with at least 50% reduction, and 100% reduction in total number of asthma exacerbations were 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).
From Baseline period (Week -52 to Week 0) to Study period (Week 0 to Week 52)
Cumulative Asthma Exacerbation Days (Subgroups of Participants)
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
The cumulative asthma exacerbation days over 52 weeks before [baseline period (BP)] and after initiation of tezepelumab [study period (SP)] were 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).
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Rate of Asthma Exacerbations Associated With Hospitalizations (Subgroups of Participants)
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Rate of asthma exacerbations associated with hospitalization over 52 weeks before [baseline period (BP)] and after initiation of tezepelumab [study period (SP)] was assessed in the following subgroups of participants: BEC ≥300 cells/µL; BEC <300 cells/µL; With a clinically-relevant allergy to perennial aeroallergen; Without a clinically-relevant allergy to 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).
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Rate of Asthma Exacerbations Associated With Emergency Department/Urgent Care (ED/UC) Visits (Subgroups of Participants)
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Rate of asthma exacerbations associated with ED/UC visits over 52 weeks before [baseline period (BP)] and after initiation of tezepelumab [study period (SP)] was assessed in following subgroups of participants: BEC ≥300 cells/µL; BEC <300 cells/µL; With a clinically-relevant allergy to perennial aeroallergen; Without a clinically-relevant allergy to 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).
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Rate of Asthma Exacerbations Associated With Hospitalizations or ED/UC Visits (Subgroups of Participants)
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Rate of asthma exacerbations associated with hospitalizations or ED/UC visits over 52 weeks before [baseline period (BP)] and after initiation of tezepelumab [study period (SP)] was assessed in following subgroups of participants: BEC ≥300 cells/µL; BEC <300 cells/µL; With clinically-relevant allergy to perennial aeroallergen; Without clinically-relevant allergy to 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).
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Number and Type of Asthma-related HRU (Subgroups of Participants)
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

Number of participants with specific type of asthma related HRU in the 12-month period before [baseline period (BP)] and after initiation of tezepelumab [up to study Week 52 = study period (SP)] were 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).

FEIA = Fluorescent enzyme immunoassay
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Duration of Asthma-related Hospitalizations (Subgroups of Participants)
Tidsramme: Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)
Duration of asthma-related hospitalization in 12-month period before [baseline period (BP)] and after initiation of tezepelumab [up to study Week 52 = study period (SP)] was assessed in following subgroups of participants: BEC≥300 cells/µL; BEC<300 cells/µL; With clinically-relevant allergy to perennial aeroallergen; Without clinically-relevant allergy to 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).
Baseline period (Week -52 to Week 0), Study period (Week 0 to Week 52)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With Serious Adverse Events (SAEs), Adverse Events That Lead to Tezepelumab Treatment Discontinuation (DAEs), and Adverse Events of Special Interest (AESIs)
Tidsramme: Up to Week 52
The safety and tolerability of tezepelumab were assessed. Data for adverse events on-treatment period have been presented.
Up to Week 52

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Samarbejdspartnere

Parexel

Efterforskere

  • Ledende efterforsker: Njira Lugogo., MD., University of Michigan Health. Michigan, USA

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. april 2022

Primær færdiggørelse (Faktiske)

1. oktober 2025

Studieafslutning (Faktiske)

1. oktober 2025

Datoer for studieregistrering

Først indsendt

17. marts 2022

Først indsendt, der opfyldte QC-kriterier

7. april 2022

Først opslået (Faktiske)

14. april 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • D5180C00032
  • 2026-000081-25 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Kvalificerede forskere kan anmode om adgang til anonymiserede individuelle data på patientniveau fra AstraZeneca gruppe af virksomheder sponsoreret kliniske forsøg via anmodningsportalen. Alle anmodninger vil blive evalueret i henhold til AZ-offentliggørelsesforpligtelsen:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Ja, angiver, at AZ accepterer anmodninger om IPD, men det betyder ikke, at alle anmodninger vil blive delt.

IPD-delingstidsramme

AstraZeneca vil opfylde eller overgå datatilgængeligheden i henhold til forpligtelserne i henhold til EFPIA Pharmas datadelingsprincipper. For detaljer om vores tidslinjer henvises til vores offentliggørelsesforpligtelse på https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-delingsadgangskriterier

Når en anmodning er blevet godkendt, giver AstraZeneca adgang til de afidentificerede individuelle data på patientniveau i et godkendt sponsoreret værktøj. Underskrevet datadelingsaftale (ikke-omsættelig kontrakt for dataadgangere) skal være på plads, før du får adgang til de ønskede oplysninger. Derudover skal alle brugere acceptere vilkårene og betingelserne for SAS MSE for at få adgang. For yderligere detaljer, bedes du læse oplysningserklæringerne på https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner