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Effektivitets- og sikkerhetsstudie av Tezepelumab hos voksne og ungdommer med alvorlig astma i USA (PASSAGE)

15. juli 2026 oppdatert av: AstraZeneca

En multisenter, enarms, åpen etikett, etter-godkjenning, fase 4 effektivitet og sikkerhet studie av Tezepelumab hos voksne og ungdommer med alvorlig astma, inkludert flere understuderte populasjoner i USA (PASSAGE)

For å vurdere effektiviteten og sikkerheten til tezepelumab hos voksne og ungdommer med alvorlig astma, inkludert flere understuderte populasjoner i USA.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Dette er en multisenter, enarms, åpen fase 4-studie etter autorisasjon for å vurdere effektiviteten av tezepelumab i USA (USA) blant en reell befolkning av voksne og ungdommer med astma som krever middels dose. til høydose inhalerte kortikosteroider (ICS), med ytterligere kontroller(er) i minst 12 måneder med dokumentert historie med minst 2 astmaforverringer i løpet av året. Den totale varigheten av studien for hver deltaker vil være omtrent 56 uker. Omtrent 400 deltakere vil bli påmeldt. Deltakerne vil motta tezepelumab via subkutan injeksjon på studiestedet, over en 48-ukers behandlingsperiode. Studien inkluderer også en oppfølgingsperiode etter dosering fra uke 48 til 52.

Studietype

Intervensjonell

Registrering (Faktiske)

286

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

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

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Mannlig eller kvinnelig deltaker må være 12 år eller eldre på tidspunktet for undertegning av skjemaet for informert samtykke eller samtykke.
  • Dokumentert legediagnostisert astma i minst 12 måneder og bekreftet av etterforskeren å ikke skyldes alternative diagnoser.
  • Dokumentert behandling med middels til høy dose ICS i henhold til Global Initiative for Asthma (GINA) retningslinjer (GINA 2021) i minst 12 måneder.
  • Bruk av ytterligere astmavedlikeholdskontroller(er) i tillegg til ICS i minst 12 måneder. Den ekstra vedlikeholdskontrollmedisinen kan være inneholdt i et kombinasjonsprodukt (f.eks. ICS/langtidsvirkende β-agonist (LABA)).
  • Dokumentert historie med minst 2 astmaeksaserbasjoner i løpet av de 12 månedene.
  • Legens avgjørelse om at deltakeren er kvalifisert for behandling med tezepelumab i henhold til godkjent amerikansk produktvedlegg (USPI).
  • Får for tiden omsorg fra spesialistleger (f.eks. lungeleger og/eller allergiker).
  • Fullførte hele kurset med covid-19-vaksinasjon minst 28 dager før tezepelumab-administrasjon. Å ta en godkjent vaksinebooster er ikke et krav for å delta i denne studien.
  • Utlevering av signert og datert skriftlig informert samtykkeskjema.

Ekskluderingskriterier:

  • Enhver kontraindikasjon for tezepelumab i henhold til den amerikanske godkjente produktetiketten eller etter etterforskerens mening.
  • Komorbid diagnose av alvorlig eller svært alvorlig kronisk obstruktiv lungesykdom (KOLS) i henhold til GOLDs retningslinjer (GOLD 2021).
  • Tidligere biologisk bruk for behandling av astma innen 4 måneder eller 5 halveringstider (avhengig av hva som er lengst).
  • Deltakelse i en intervensjonell klinisk studie for astma innen 12 måneder.
  • Bedømmelse fra etterforskeren om at det er usannsynlig at deltakeren vil overholde studieprosedyrer, restriksjoner og krav.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Tezepelumab
Deltakerne vil motta 210 mg tezepelumab hver 4. uke (Q4W) fra uke 0 til uke 48.
Legemiddel: Tezepelumab
Deltakerne vil få subkutan injeksjon av tezepelumab.
Andre navn:
  • AMG 157 eller MEDI9929

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Samarbeidspartnere

Parexel

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. april 2022

Primær fullføring (Faktiske)

1. oktober 2025

Studiet fullført (Faktiske)

1. oktober 2025

Datoer for studieregistrering

Først innsendt

17. mars 2022

Først innsendt som oppfylte QC-kriteriene

7. april 2022

Først lagt ut (Faktiske)

14. april 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Kvalifiserte forskere kan be om tilgang til anonymiserte individuelle data på pasientnivå fra AstraZeneca gruppe av selskaper sponset kliniske studier via forespørselsportalen. Alle forespørsler vil bli evaluert i henhold til AZ-avsløringsforpliktelsen:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Ja, indikerer at AZ aksepterer forespørsler om IPD, men dette betyr ikke at alle forespørsler vil bli delt.

IPD-delingstidsramme

AstraZeneca vil oppfylle eller overgå datatilgjengelighet i henhold til forpliktelsene som er gitt til EFPIA Pharmas datadelingsprinsipper. For detaljer om tidslinjene våre, vennligst referer til vår avsløringsforpliktelse på https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Tilgangskriterier for IPD-deling

Når en forespørsel er godkjent, vil AstraZeneca gi tilgang til de avidentifiserte individuelle dataene på pasientnivå i et godkjent sponset verktøy. Signert datadelingsavtale (ikke-omsettelig kontrakt for dataaksessors) må være på plass før du får tilgang til forespurt informasjon. I tillegg må alle brukere godta vilkårene og betingelsene til SAS MSE for å få tilgang. For ytterligere detaljer, vennligst se Disclosure Statements på https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere