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Estudo de Eficácia e Segurança do Tezepelumabe em Adultos e Adolescentes Participantes com Asma Grave nos Estados Unidos (PASSAGE)

15 de julho de 2026 atualizado por: AstraZeneca

Um estudo multicêntrico, de braço único, aberto, pós-autorização, eficácia e segurança de Fase 4 do Tezepelumabe em participantes adultos e adolescentes com asma grave, incluindo várias populações pouco estudadas nos Estados Unidos (PASSAGE)

Avaliar a eficácia e segurança do tezepelumabe em participantes adultos e adolescentes com asma grave, incluindo várias populações pouco estudadas nos Estados Unidos.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Este é um estudo multicêntrico, de braço único, aberto, pós-autorização, Fase 4 para avaliar a eficácia do tezepelumabe nos Estados Unidos (EUA) entre uma população do mundo real de adultos e adolescentes participantes com asma que requerem dose média a altas doses de corticosteroides inalatórios (ICS), com controlador(es) adicional(is) por pelo menos 12 meses com história documentada de pelo menos 2 exacerbações de asma durante o ano. A duração total do estudo para cada participante será de aproximadamente 56 semanas. Serão aproximadamente 400 inscritos. Os participantes receberão tezepelumab por injeção subcutânea no local do estudo, durante um período de tratamento de 48 semanas. O estudo também inclui um período de acompanhamento pós-dosagem das semanas 48 a 52.

Tipo de estudo

Intervencional

Inscrição (Real)

286

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

12 anos a 130 anos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • O participante do sexo masculino ou feminino deve ter 12 anos de idade ou mais, no momento da assinatura do formulário de consentimento informado ou consentimento.
  • Asma diagnosticada por médico documentada por pelo menos 12 meses e confirmada pelo investigador como não sendo devida a diagnósticos alternativos.
  • Tratamento documentado com dose média a alta de CI de acordo com as diretrizes da Global Initiative for Asthma (GINA) (GINA 2021) por pelo menos 12 meses.
  • Uso de medicamento(s) adicional(is) para o controle da asma além do CI por pelo menos 12 meses. A medicação controladora de manutenção adicional pode estar contida em um produto combinado (por exemplo, CI/ β-agonista de ação prolongada (LABA)).
  • História documentada de pelo menos 2 exacerbações de asma durante os 12 meses.
  • Decisão do médico de que o participante é elegível para tratamento com tezepelumabe de acordo com o folheto do produto aprovado nos Estados Unidos (USPI).
  • Atualmente recebendo atendimento de médicos especialistas (por exemplo, pneumologistas e/ou alergistas).
  • Concluiu o esquema completo de vacinação contra COVID-19 pelo menos 28 dias antes da administração de tezepelumabe. Tomar um reforço de vacina aprovado não é um requisito para participar deste estudo.
  • Fornecimento de formulário de consentimento informado assinado e datado.

Critério de exclusão:

  • Qualquer contra-indicação ao tezepelumab de acordo com o rótulo do produto aprovado nos EUA ou na opinião do investigador.
  • Diagnóstico de comorbidade de doença pulmonar obstrutiva crônica (DPOC) grave ou muito grave de acordo com as diretrizes GOLD (GOLD 2021).
  • Uso biológico prévio para o tratamento da asma em 4 meses ou 5 meias-vidas (o que for mais longo).
  • Participação em um ensaio clínico intervencionista para asma em 12 meses.
  • Julgamento do Investigador de que é improvável que o participante cumpra os procedimentos, restrições e requisitos do estudo.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Tezepelumabe
Os participantes receberão 210 mg de tezepelumabe a cada 4 semanas (Q4W) da semana 0 até a semana 48.
Medicamento: Tezepelumabe
Os participantes receberão injeção subcutânea de tezepelumabe.
Outros nomes:
  • AMG 157 ou MEDI9929

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Annualized Asthma Exacerbation Rate (AAER)
Prazo: 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)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of Participants With Asthma Exacerbations
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Number of Participants With Serious Adverse Events (SAEs), Adverse Events That Lead to Tezepelumab Treatment Discontinuation (DAEs), and Adverse Events of Special Interest (AESIs)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

AstraZeneca

Colaboradores

Parexel

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

29 de abril de 2022

Conclusão Primária (Real)

1 de outubro de 2025

Conclusão do estudo (Real)

1 de outubro de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

17 de março de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

7 de abril de 2022

Primeira postagem (Real)

14 de abril de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Pesquisadores qualificados podem solicitar acesso a dados anônimos de pacientes individuais do grupo AstraZeneca de ensaios clínicos patrocinados por empresas por meio do portal de solicitação. Todas as solicitações serão avaliadas de acordo com o compromisso de divulgação AZ:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Sim, indica que AZ está aceitando solicitações de IPD, mas isso não significa que todas as solicitações serão compartilhadas.

Prazo de Compartilhamento de IPD

A AstraZeneca atenderá ou excederá a disponibilidade de dados de acordo com os compromissos assumidos com os Princípios de Compartilhamento de Dados Farmacêuticos da EFPIA. Para obter detalhes sobre nossos cronogramas, consulte novamente nosso compromisso de divulgação em https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Critérios de acesso de compartilhamento IPD

Quando uma solicitação for aprovada, a AstraZeneca fornecerá acesso aos dados individuais não identificados no nível do paciente em uma ferramenta patrocinada aprovada. O Contrato de Compartilhamento de Dados assinado (contrato não negociável para acessadores de dados) deve estar em vigor antes de acessar as informações solicitadas. Além disso, todos os usuários precisarão aceitar os termos e condições do SAS MSE para obter acesso. Para obter detalhes adicionais, consulte as declarações de divulgação em https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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