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A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma

28 de mayo de 2015 actualizado por: Teva Branded Pharmaceutical Products R&D, Inc.

A 12-week Comparison of the Efficacy and Safety of Albuterol Spiromax® Versus Placebo in Subjects 12 Years and Older With Persistent Asthma

The study will measure the change in lung function in subjects with asthma after inhaling from either of two inhalers: Albuterol Spiromax® or placebo.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

158

Fase

  • Fase 3

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
      • Birmingham, Alabama, Estados Unidos
        • Teva Investigational Site 10077
    • Arizona
      • Phoenix, Arizona, Estados Unidos
        • Teva Investigational Site 10079
    • California
      • Costa Mesa, California, Estados Unidos
        • Teva Investigational Site 10569
      • Fountain Valley, California, Estados Unidos
        • Teva Investigational Site 10053
      • Huntington Beach, California, Estados Unidos
        • Teva Investigational Site 10065
      • Huntington Beach, California, Estados Unidos
        • Teva Investigational Site 10572
      • Los Angeles, California, Estados Unidos
        • Teva Investigational Site 10075
      • Roseville, California, Estados Unidos
        • Teva Investigational Site 10061
      • San Diego, California, Estados Unidos
        • Teva Investigational Site 10066
    • Colorado
      • Denver, Colorado, Estados Unidos
        • Teva Investigational Site 10068
      • Denver, Colorado, Estados Unidos
        • Teva Investigational Site 10069
    • Florida
      • Miami, Florida, Estados Unidos
        • Teva Investigational Site 10058
      • Miami, Florida, Estados Unidos
        • Teva Investigational Site 10060
      • Ormond Beach, Florida, Estados Unidos
        • Teva Investigational Site 10064
    • Georgia
      • Savannah, Georgia, Estados Unidos
        • Teva Investigational Site 10071
    • Kansas
      • Wichita, Kansas, Estados Unidos
        • Teva Investigational Site 10073
    • Kentucky
      • Owensboro, Kentucky, Estados Unidos
        • Teva Investigational Site 10070
    • Maryland
      • Bethesda, Maryland, Estados Unidos
        • Teva Investigational Site 10063
      • Gaithersburg, Maryland, Estados Unidos
        • Teva Investigational Site 10571
      • Wheaton, Maryland, Estados Unidos
        • Teva Investigational Site 10067
    • Missouri
      • St. Louis, Missouri, Estados Unidos
        • Teva Investigational Site 10072
    • Montana
      • Missoula, Montana, Estados Unidos
        • Teva Investigational Site 10050
    • North Carolina
      • Raleigh, North Carolina, Estados Unidos
        • Teva Investigational Site 10057
    • Ohio
      • Cincinnati, Ohio, Estados Unidos
        • Teva Investigational Site 10051
      • Sylvania, Ohio, Estados Unidos
        • Teva Investigational Site 10078
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos
        • Teva Investigational Site 10054
      • Oklahoma City, Oklahoma, Estados Unidos
        • Teva Investigational Site 10568
      • Tulsa, Oklahoma, Estados Unidos
        • Teva Investigational Site 10055
    • Oregon
      • Medford, Oregon, Estados Unidos
        • Teva Investigational Site 10056
      • Medford, Oregon, Estados Unidos
        • Teva Investigational Site 10076
    • South Carolina
      • Charleston, South Carolina, Estados Unidos
        • Teva Investigational Site 10684
      • Spartanburg, South Carolina, Estados Unidos
        • Teva Investigational Site 10570
    • Texas
      • Live Oak, Texas, Estados Unidos
        • Teva Investigational Site 10049
      • San Antonio, Texas, Estados Unidos
        • Teva Investigational Site 10052
      • Waco, Texas, Estados Unidos
        • Teva Investigational Site 10685
    • Virginia
      • Fairfax, Virginia, Estados Unidos
        • Teva Investigational Site 10059
    • Washington
      • Puyallup, Washington, Estados Unidos
        • Teva Investigational Site 10074
      • Tacoma, Washington, Estados Unidos
        • Teva Investigational Site 10062

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 y mayores (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Written informed consent/assent
  • General good health
  • Persistent asthma, with an FEV1 50-80% predicted.
  • Ability to perform spirometry in an acceptable manner as per protocol guidelines.
  • Ability to perform PEFR with a handheld peak flow meter.
  • Demonstration of reversible bronchoconstriction as verified by a 15% or greater increase from baseline FEV1.
  • Taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit.
  • Non-smokers.
  • Capable of understanding the requirements, risks, and benefits of study participation.
  • Other inclusion criteria apply.

Exclusion Criteria:

  • Participation in any investigational drug trial within the 30 days preceding the Screening Visit (SV).
  • A known hypersensitivity to albuterol or any of the excipients in the formulations.
  • History of severe milk protein allergy.
  • History of a respiratory infection or disorder that has not resolved within the 2 weeks preceding the Screening Visit (SV).
  • Currently requires treatment with β2-adrenergic receptor antagonists or non-selective β-receptor blocking agents.
  • History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.
  • Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit (SV). A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit (SV).
  • Historical or current evidence of any clinically significant non-asthmatic acute or chronic condition including.
  • Other exclusion criteria apply.

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo MDPI
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
Droga: Placebo MDPI
Placebo MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
Otros nombres:
  • Placebo Spiromax®
Experimental: Albuterol MDPI
Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
Droga: Albuterol MDPI
Albuterol MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
Otros nombres:
  • ProAir® RespiClick, Albuterol Spiromax®

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period
Periodo de tiempo: Day 1, Day 8 and Day 85

FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. It represents the weighted average (by the trapezoidal rule) of FEV1 AUC 0-6 measures adjusted for the baseline measure (i.e., change from baseline at each timepoint) recorded on days 1, 8 and 85 of the treatment period. The baseline for each study day was the average of the 2 pre-dose FEV1 measurements on that study day.

FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.
Day 1, Day 8 and Day 85

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1
Periodo de tiempo: Day 1

FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 1.

FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.
Day 1
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 8
Periodo de tiempo: Day 8

FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 8.

FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.
Day 8
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 85
Periodo de tiempo: Day 85

FEV1 AUC 0-6 is the area under the effect-time curve from time 0 (pre-dose) up to 6 hours post-dose. The baseline was the average of the 2 pre-dose FEV1 measurements on that study day. The baseline-adjustment refers to change from baseline at each post dose timepoint recorded on Day 85.

FEV1 was measured using spirometry. Spirometry assessments were obtained predose at -30 ± 5, and - 5 minutes, then post dose at 5 ± 2, 15 ± 5, 30 ± 5, 45 ± 5 minutes, and at 1hr ± 5 min, 2hr ± 5 min, 3hr ± 5 min, 4hr ± 5 min, 5hr ± 5 min, and 6hr ± 5 min.
Day 85
Participants With Adverse Events
Periodo de tiempo: Day 1 to Day 92
Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Day 1 to Day 92
Physical Examination Findings Shifts From Baseline to Endpoint by Treatment Group
Periodo de tiempo: Day 1 (Baseline), Day 85
Physical exam was recorded as normal or abnormal based on physician assessment. Format for results is: Test Baseline/Endpoint HEENT = head, eyes, ears, nose, throat
Day 1 (Baseline), Day 85
Participants With Clinically Significant Vital Sign Assessments
Periodo de tiempo: Day 8, Day 85

For both standard and serial vital signs, participants were seated for at least 5 minutes before vital signs were assessed. Heart rate was obtained prior to the blood pressure measurement. Serial heart rate and blood pressure were conducted in the sitting position prior to the spirometry assessment; baseline measures were taken pre-dose at -30 ± 5 and -5 minutes on Day 1. Day 85 serial vital sign measures were taken in the sitting position prior to spirometry assessments pre-dose at -30 ± 5 and -5 minutes, then post-dose at 30 (±5) minutes, 1hr (± 10 min), 2hr (± 10 min), 3hr (± 10 min), 4hr (± 10 min), 5hr (± 10 min) and 6 hr (± 10 min).

Serial heart rate and blood pressure measurements that were elevated to the following criteria were considered clinically significant:

Systolic blood pressure: > 160 beats/minute Diastolic blood pressure: >100 beats/minute Heart rate: >120 beats/minute
Day 8, Day 85

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Percent Change From Baseline in FEV1 AUC 0-6 Over the 12-week Treatment Period
Periodo de tiempo: Day 1, Day 8, Day 85
Day 1, Day 8, Day 85
Percent Change From Baseline in FEV1 AUC 0-6
Periodo de tiempo: Day 1
Day 1
Percent Change From Baseline in FEV1 AUC
Periodo de tiempo: Day 8
Day 8
Percent Change From Baseline in FEV1 AUC
Periodo de tiempo: Day 85
Day 85
Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose Over the 12-week Treatment Period
Periodo de tiempo: Day 1, Day 8, Day 85
Day 1, Day 8, Day 85
Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 1
Periodo de tiempo: Day 1
Day 1
Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 8
Periodo de tiempo: Day 8
Day 8
Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 85
Periodo de tiempo: Day 85
Day 85
Time to Onset of Effect (Change in FEV1 of 12% From Baseline Within 30 Minutes Postdose)
Periodo de tiempo: Day 1, Day 8, Day 85
Day 1, Day 8, Day 85
Duration of Response Measured From the Time Post-dosing to the First Time After the Response Onset (Increase ≥12% Above Baseline) When the FEV1 Decreases to Less Than 12% Above Baseline (Within 6 Hours After Dosing) for Those Who Responded in 30 Minutes
Periodo de tiempo: Day 1, Day 8, Day 85
Day 1, Day 8, Day 85
Time to Onset of Effect (Change in FEV1 of 15% From Baseline Within 30 Minutes Postdose)for Those Who Responded in 30 Minutes
Periodo de tiempo: Day 1, Day 8, Day 85
Day 1, Day 8, Day 85
Duration of Response on Days 1, 8 and 85
Periodo de tiempo: Day 1, Day 8, Day 85
Duration of response measured from the time post-dosing to the first time after the response onset (increase ≥15% above baseline) when the FEV1 decreases to less than 15% above baseline (within 6 hours after dosing) for those who responded within 30 minutes
Day 1, Day 8, Day 85
Percent of Symptom Free Days on the Patient Diary
Periodo de tiempo: Treatment days 1 through 85
Treatment days 1 through 85
Percent of Rescue Medication Free Days in the Patient Diary
Periodo de tiempo: Treatment days 1 through 85
Treatment days 1 through 85
Morning Peak Expiratory Flow Reading Reported on Patient Diary
Periodo de tiempo: Treatment days 1 through 85
Treatment days 1 through 85

Colaboradores e Investigadores

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

Patrocinador

Teva Branded Pharmaceutical Products R&D, Inc.

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

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

1 de diciembre de 2012

Finalización primaria (Actual)

1 de octubre de 2013

Finalización del estudio (Actual)

1 de noviembre de 2013

Fechas de registro del estudio

Enviado por primera vez

25 de agosto de 2011

Primero enviado que cumplió con los criterios de control de calidad

25 de agosto de 2011

Publicado por primera vez (Estimar)

29 de agosto de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

26 de junio de 2015

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

28 de mayo de 2015

Última verificación

1 de mayo de 2015

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • ABS-AS-301

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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