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Estudio de eficacia y seguridad de tezepelumab en participantes adultos y adolescentes con asma grave en los Estados Unidos (PASSAGE)

15 de julio de 2026 actualizado por: AstraZeneca

Un estudio multicéntrico, de un solo brazo, abierto, posterior a la autorización, de fase 4 sobre eficacia y seguridad de tezepelumab en participantes adultos y adolescentes con asma grave que incluye varias poblaciones poco estudiadas en los Estados Unidos (PASSAGE)

Evaluar la efectividad y la seguridad de tezepelumab en participantes adultos y adolescentes con asma grave, incluidas varias poblaciones poco estudiadas en los Estados Unidos.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Este es un estudio multicéntrico, de un solo brazo, abierto, posterior a la autorización, de fase 4 para evaluar la efectividad de tezepelumab en los Estados Unidos (EE. UU.) entre una población real de participantes adultos y adolescentes con asma que requieren una dosis media. a dosis altas de corticosteroides inhalados (ICS), con controlador(es) adicional(es) durante al menos 12 meses con antecedentes documentados de al menos 2 exacerbaciones de asma durante el año. La duración total del estudio para cada participante será de aproximadamente 56 semanas. Se inscribirán aproximadamente 400 participantes. Los participantes recibirán tezepelumab mediante inyección subcutánea en el sitio del estudio, durante un período de tratamiento de 48 semanas. El estudio también incluye un período de seguimiento posterior a la dosificación de las semanas 48 a 52.

Tipo de estudio

Intervencionista

Inscripción (Actual)

286

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • 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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años a 130 años (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • El participante masculino o femenino debe tener 12 años de edad o más, al momento de firmar el formulario de consentimiento informado o asentimiento.
  • Asma diagnosticada por un médico documentada durante al menos 12 meses y confirmada por el investigador que no se debe a diagnósticos alternativos.
  • Tratamiento documentado con dosis medias a altas de ICS según las pautas de la Iniciativa Global para el Asma (GINA) (GINA 2021) durante al menos 12 meses.
  • Uso de medicamentos adicionales para el control del asma además de los ICS durante al menos 12 meses. El medicamento controlador de mantenimiento adicional puede estar contenido en un producto combinado (p. ej., ICS/agonista β de acción prolongada (LABA)).
  • Antecedentes documentados de al menos 2 exacerbaciones de asma durante los 12 meses.
  • Decisión del médico de que el participante es elegible para el tratamiento con tezepelumab de acuerdo con el prospecto del producto aprobado en los Estados Unidos (USPI).
  • Recibe actualmente atención de médicos especialistas (p. ej., neumólogos y/o alergólogos).
  • Completar el ciclo completo de vacunación contra la COVID-19 al menos 28 días antes de la administración de tezepelumab. Tomar un refuerzo de vacuna aprobado no es un requisito para participar en este estudio.
  • Entrega de un formulario de consentimiento informado por escrito firmado y fechado.

Criterio de exclusión:

  • Cualquier contraindicación para tezepelumab según la etiqueta del producto aprobado en EE. UU. o en opinión del investigador.
  • Diagnóstico comórbido de enfermedad pulmonar obstructiva crónica (EPOC) grave o muy grave según las directrices GOLD (GOLD 2021).
  • Uso biológico previo para el tratamiento del asma dentro de los 4 meses o 5 semividas (lo que sea más largo).
  • Participación en un ensayo clínico de intervención para el asma dentro de los 12 meses.
  • Juicio del investigador de que es improbable que el participante cumpla con los procedimientos, restricciones y requisitos del estudio.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Tezepelumab
Los participantes recibirán 210 mg de tezepelumab cada 4 semanas (Q4W) desde la semana 0 hasta la semana 48.
Droga: Tezepelumab
Los participantes recibirán una inyección subcutánea de tezepelumab.
Otros nombres:
  • AMG 157 o MEDI9929

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Annualized Asthma Exacerbation Rate (AAER)
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Asthma Exacerbations
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With Serious Adverse Events (SAEs), Adverse Events That Lead to Tezepelumab Treatment Discontinuation (DAEs), and Adverse Events of Special Interest (AESIs)
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

AstraZeneca

Colaboradores

Parexel

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

29 de abril de 2022

Finalización primaria (Actual)

1 de octubre de 2025

Finalización del estudio (Actual)

1 de octubre de 2025

Fechas de registro del estudio

Enviado por primera vez

17 de marzo de 2022

Primero enviado que cumplió con los criterios de control de calidad

7 de abril de 2022

Publicado por primera vez (Actual)

14 de abril de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Los investigadores calificados pueden solicitar acceso a datos anónimos a nivel de pacientes individuales de los ensayos clínicos patrocinados por el grupo de empresas AstraZeneca a través del portal de solicitudes. Todas las solicitudes se evaluarán según el compromiso de divulgación de AZ:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Sí, indica que AZ está aceptando solicitudes de IPD, pero esto no significa que se compartirán todas las solicitudes.

Marco de tiempo para compartir IPD

AstraZeneca cumplirá o superará la disponibilidad de datos según los compromisos adquiridos con los Principios de intercambio de datos farmacéuticos de EFPIA. Para obtener detalles sobre nuestros plazos, consulte nuestro compromiso de divulgación en https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Criterios de acceso compartido de IPD

Cuando se haya aprobado una solicitud, AstraZeneca brindará acceso a los datos de nivel de paciente individual anonimizados en una herramienta patrocinada aprobada. El Acuerdo de intercambio de datos firmado (contrato no negociable para quienes acceden a los datos) debe estar vigente antes de acceder a la información solicitada. Además, todos los usuarios deberán aceptar los términos y condiciones de SAS MSE para obtener acceso. Para obtener detalles adicionales, revise las declaraciones de divulgación en https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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