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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 maio de 2015 atualizado 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

158

Estágio

  • Fase 3

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
      • 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

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 e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

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: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo MDPI
Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
Medicamento: 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.
Outros nomes:
  • 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.
Medicamento: 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.
Outros nomes:
  • ProAir® RespiClick, Albuterol Spiromax®

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) Over the 12-week Treatment Period
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Baseline-adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC 0-6) on Day 1
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Percent Change From Baseline in FEV1 AUC 0-6 Over the 12-week Treatment Period
Prazo: Day 1, Day 8, Day 85
Day 1, Day 8, Day 85
Percent Change From Baseline in FEV1 AUC 0-6
Prazo: Day 1
Day 1
Percent Change From Baseline in FEV1 AUC
Prazo: Day 8
Day 8
Percent Change From Baseline in FEV1 AUC
Prazo: Day 85
Day 85
Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose Over the 12-week Treatment Period
Prazo: 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
Prazo: Day 1
Day 1
Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 8
Prazo: Day 8
Day 8
Maximum Percent Change From Baseline in FEV1 Within 2 Hours Post Dose on Day 85
Prazo: Day 85
Day 85
Time to Onset of Effect (Change in FEV1 of 12% From Baseline Within 30 Minutes Postdose)
Prazo: 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
Prazo: 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
Prazo: Day 1, Day 8, Day 85
Day 1, Day 8, Day 85
Duration of Response on Days 1, 8 and 85
Prazo: 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
Prazo: Treatment days 1 through 85
Treatment days 1 through 85
Percent of Rescue Medication Free Days in the Patient Diary
Prazo: Treatment days 1 through 85
Treatment days 1 through 85
Morning Peak Expiratory Flow Reading Reported on Patient Diary
Prazo: Treatment days 1 through 85
Treatment days 1 through 85

Colaboradores e Investigadores

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

Patrocinador

Teva Branded Pharmaceutical Products R&D, Inc.

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

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

1 de dezembro de 2012

Conclusão Primária (Real)

1 de outubro de 2013

Conclusão do estudo (Real)

1 de novembro de 2013

Datas de inscrição no estudo

Enviado pela primeira vez

25 de agosto de 2011

Enviado pela primeira vez que atendeu aos critérios de CQ

25 de agosto de 2011

Primeira postagem (Estimativa)

29 de agosto de 2011

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

26 de junho de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de maio de 2015

Última verificação

1 de maio de 2015

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ABS-AS-301

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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