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Tezepelumabin tehokkuus- ja turvallisuustutkimus aikuisilla ja nuorilla potilailla, joilla on vaikea astma Yhdysvalloissa (PASSAGE)

keskiviikko 15. heinäkuuta 2026 päivittänyt: AstraZeneca

Monikeskus, yksihaarainen, avoin, luvan myöntämisen jälkeinen, vaiheen 4 tehokkuus- ja turvallisuustutkimus tezepelumabista aikuisilla ja nuorilla, joilla on vaikea astma, mukaan lukien useita alitutkittuja väestöryhmiä Yhdysvalloissa (PASSAGE)

Arvioida tezepelumabin tehokkuutta ja turvallisuutta aikuisilla ja nuorilla potilailla, joilla on vaikea astma, mukaan lukien useita alitutkittuja väestöryhmiä Yhdysvalloissa.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

Tämä on monikeskus, yksihaarainen, avoin, myyntiluvan myöntämisen jälkeinen vaihe 4 tutkimus, jolla arvioidaan tezepelumabin tehokkuutta Yhdysvalloissa (Yhdysvalloissa) aikuisten ja nuorten potilaiden keskuudessa, jotka sairastavat astmaa ja vaativat keskiannosta. suuriannoksisille inhaloitaville kortikosteroideille (ICS) lisäkontrolleilla vähintään 12 kuukauden ajan ja dokumentoidulla historialla vähintään 2 astman pahenemista vuoden aikana. Tutkimuksen kokonaiskesto kunkin osallistujan osalta on noin 56 viikkoa. Mukaan otetaan noin 400 osallistujaa. Osallistujat saavat tetsepelumabia ihonalaisena injektiona tutkimuskohteeseen 48 viikon hoitojakson aikana. Tutkimukseen sisältyy myös annostelun jälkeinen seurantajakso viikoilta 48–52.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

286

Vaihe

  • Vaihe 4

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

12 vuotta - 130 vuotta (Lapsi, Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

Sisällyttämiskriteerit:

  • Mies- tai naispuolisen osallistujan tulee olla vähintään 12-vuotias tietoisen suostumuslomakkeen tai suostumuksen allekirjoitushetkellä.
  • Dokumentoitu lääkärin diagnosoima astma vähintään 12 kuukauden ajan ja tutkijan vahvistama, että se ei johdu vaihtoehtoisista diagnooseista.
  • Dokumentoitu hoito keskisuuren tai suuren annoksen ICS:llä Global Initiative for Asthma (GINA) -ohjeiden (GINA 2021) mukaisesti vähintään 12 kuukauden ajan.
  • Ylimääräisten astman ylläpitolääkkeiden käyttö ICS:n lisäksi vähintään 12 kuukauden ajan. Ylimääräinen ylläpitosäädinlääke voi olla yhdistelmätuotteessa (esim. ICS/pitkävaikutteinen β-agonisti (LABA)).
  • Dokumentoitu historia vähintään 2 astman pahenemisesta 12 kuukauden aikana.
  • Lääkäri päättää, että osallistuja on oikeutettu tezepelumabihoitoon Yhdysvaltain hyväksytyn tuoteselosteen (USPI) mukaisesti.
  • Saat tällä hetkellä hoitoa erikoislääkäreiltä (esim. keuhkolääkärit ja/tai allergialääkärit).
  • Täysi COVID-19-rokotus on suoritettu vähintään 28 päivää ennen tezepelumabin antamista. Tähän tutkimukseen osallistuminen ei edellytä hyväksytyn rokotteen ottamista.
  • Allekirjoitetun ja päivätyn kirjallisen tietoisen suostumuslomakkeen toimittaminen.

Poissulkemiskriteerit:

  • Kaikki tezepelumabin vasta-aiheet USA:n hyväksymän tuotteen etiketin tai tutkijan lausunnon mukaan.
  • Vaikean tai erittäin vaikean kroonisen obstruktiivisen keuhkosairauden (COPD) samanaikainen diagnoosi GOLD-ohjeiden (GOLD 2021) mukaan.
  • Aiempi biologinen käyttö astman hoitoon 4 kuukauden tai 5 puoliintumisajan sisällä (sen mukaan kumpi on pidempi).
  • Osallistuminen interventiokliiniseen astman tutkimukseen 12 kuukauden sisällä.
  • Tutkijan arvio, jonka mukaan osallistuja ei todennäköisesti noudata tutkimusmenettelyjä, rajoituksia ja vaatimuksia.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei käytössä
  • Inventiomalli: Yksittäinen ryhmätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Tezepelumabi
Osallistujat saavat 210 mg tezepelumabia joka 4. viikko (Q4W) viikosta 0 viikkoon 48.
Lääke: Tezepelumabi
Osallistujat saavat ihonalaisen tezepelumabi-injektion.
Muut nimet:
  • AMG 157 tai MEDI9929

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Annualized Asthma Exacerbation Rate (AAER)
Aikaikkuna: 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)

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Participants With Asthma Exacerbations
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Participants With Serious Adverse Events (SAEs), Adverse Events That Lead to Tezepelumab Treatment Discontinuation (DAEs), and Adverse Events of Special Interest (AESIs)
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

AstraZeneca

Yhteistyökumppanit

Parexel

Tutkijat

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

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Perjantai 29. huhtikuuta 2022

Ensisijainen valmistuminen (Todellinen)

Keskiviikko 1. lokakuuta 2025

Opintojen valmistuminen (Todellinen)

Keskiviikko 1. lokakuuta 2025

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Torstai 17. maaliskuuta 2022

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 7. huhtikuuta 2022

Ensimmäinen Lähetetty (Todellinen)

Torstai 14. huhtikuuta 2022

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Torstai 16. heinäkuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 15. heinäkuuta 2026

Viimeksi vahvistettu

Keskiviikko 1. heinäkuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

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

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

Pätevät tutkijat voivat pyytää pääsyä anonymisoituihin yksittäisiin potilastason tietoihin AstraZeneca-yritysryhmän sponsoroimista kliinisistä tutkimuksista pyyntöportaalin kautta. Kaikki pyynnöt arvioidaan AZ:n tiedonantositoumuksen mukaisesti:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Kyllä, osoittaa, että AZ hyväksyy IPD-pyyntöjä, mutta tämä ei tarkoita, että kaikki pyynnöt jaetaan.

IPD-jaon aikakehys

AstraZeneca täyttää tai ylittää tietojen saatavuuden EFPIA Pharma -tietojen jakamisperiaatteiden mukaisten sitoumusten mukaisesti. Katso tarkemmat tiedot aikatauluistamme ilmoitussitoumuksestamme osoitteessa https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-jaon käyttöoikeuskriteerit

Kun pyyntö on hyväksytty, AstraZeneca tarjoaa pääsyn yksilöimättömiin potilastason tietoihin hyväksytyssä sponsoroidussa työkalussa. Allekirjoitettu tiedonjakosopimus (ei-neuvoteltava sopimus tietojen käyttäjille) on oltava voimassa ennen pyydettyjen tietojen käyttöä. Lisäksi kaikkien käyttäjien on hyväksyttävä SAS MSE:n käyttöehdot. Lisätietoja on Disclosure Statementissä osoitteessa https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Yhdysvalloissa valmistettu ja sieltä viety tuote

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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