A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (GOLDEN-2)
6 de fevereiro de 2018 atualizado por: Sunovion Respiratory Development Inc.
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Efficacy and Safety of EP-101 (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease: GOLDEN-2 (Glycopyrrolate for Obstructive Lung Disease Via Electronic Nebulizer)
This is a randomized, double-blind, placebo-controlled, parallel arm study.
The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
This is a randomized, double-blind, placebo-controlled, parallel arm study.
The study population will consist of subjects, 35 to 75 years of age, with a diagnosis of moderate to severe COPD per Global Initiative for Chronic Obstructive Lung Disease guidelines (GOLD, 2011).
The primary analysis will compare each of the EP-101 (SUN101) dose groups to placebo with respect to the change from baseline in morning trough FEV1 on Day 29.
Trough FEV1 is defined as the mean of the two FEV1 values obtained at 23 hours 30 minutes and 24 hours after Day 28 AM dose (ie, approximately 12 hours after the previous PM dose).
Tipo de estudo
Intervencional
Inscrição (Real)
275
Estágio
- Fase 2
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
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Alabama
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Jasper, Alabama, Estados Unidos, 35501
- Jasper Summit Research, LLC
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Arizona
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Phoenix, Arizona, Estados Unidos, 85006
- Pulmonary Associates, PA
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California
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Fullerton, California, Estados Unidos, 92835
- California Research Medical Group, Inc.
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Los Angeles, California, Estados Unidos, 90095
- UCLA David Geffen School of Medicine
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Riverside, California, Estados Unidos, 92506
- Integrated Research Group
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Sacramento, California, Estados Unidos, 95819
- Capital Allergy & Respiratory Disease Center
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San Diego, California, Estados Unidos, 92120
- Institute of HealthCare Assessment, Inc.
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Florida
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Clearwater, Florida, Estados Unidos, 33765
- Clinical Research of West Florida
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Tampa, Florida, Estados Unidos, 33603
- Clinical Research of West Florida
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Georgia
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Austell, Georgia, Estados Unidos, 30106
- Georgia Clinical Research
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Lawrenceville, Georgia, Estados Unidos, 30046
- Gwinnett Biomedical Research
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Kansas
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Topeka, Kansas, Estados Unidos, 66606
- Veritas Clinical Specialities, LTD
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55407
- Minnesota Lung Center
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28207
- American Health Research
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Raleigh, North Carolina, Estados Unidos, 27607
- North Carolina Clinical Research
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45242
- New Horizons Clinical Research
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Oregon
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Medford, Oregon, Estados Unidos, 97504
- Clinical Research Institute of Southern Oregon, PC
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Medford, Oregon, Estados Unidos, 97504
- Sunstone Medical Research LLC
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Portland, Oregon, Estados Unidos, 97202
- Allergy Associates Research Center
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29615
- Upstate Pharmaceutical Research
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Greenville, South Carolina, Estados Unidos, 29615
- Greenville Pharmaceutical Research, Inc
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Spartanburg, South Carolina, Estados Unidos, 29303
- South Carolina Pharmaceutical Research
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Union, South Carolina, Estados Unidos, 29379
- CU Pharmacuetical Research
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Texas
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Houston, Texas, Estados Unidos, 77030
- Baylor College of Medicine
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New Braunfels, Texas, Estados Unidos, 78130
- Central Texas Health Research
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Virginia
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Richmond, Virginia, Estados Unidos, 23225
- Pulmonary Associates of Richmond, Inc.
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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
35 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Male and female subjects age 35 through 75 years, inclusive.
- A clinical diagnosis of moderate to severe COPD according to GOLD guidelines (2011).
- Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least 1 pack/day for 10 years, or equivalent).
- Post-bronchodilator (following inhalation of ipratropium bromide MDI) FEV1 ≥ 30% and ≤ 70% of predicted normal value during the Screening Period.
- Post-bronchodilator (following inhalation of ipratropium bromide MDI) FEV1/FVC ratio < 0.70 during the Screening Period.
- Post-bronchodilator (following inhalation of ipratropium bromide MDI) improvement in FEV1 ≥ 12% and ≥ 100 mL during the Screening Period.
- Ability to perform reproducible spirometry according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines (2005).
Subject, if female ≤ 65 years of age and of child bearing potential, must have a negative serum pregnancy test at screening. Females of childbearing potential must be instructed to and agree to avoid pregnancy during the study and must use an acceptable method of birth control:
- a. An oral contraceptive, an intrauterine device (IUD), implantable contraceptive, transdermal or injectable contraceptive for at least 1 month prior to entering the study with continued use throughout the study and for thirty days following study participation.
- b. Barrier method of contraception, eg, condom and/or diaphragm with spermicide while participating in the study.
- c. Abstinence.
- Willing and able to provide written informed consent.
Exclusion Criteria:
- Current evidence or recent history of any clinically significant and unstable disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities.
- Current evidence or history of clinically significant abnormal cardiac rhythm and/or conduction findings, including Holter monitoring results during the Screening Period.
- Concomitant pulmonary disease or primary diagnosis of asthma.
- History of malignancy of any organ system, treated or untreated within the past 5 years, with the exception of localized basal cell carcinoma of the skin
- Recent history of COPD exacerbation requiring hospitalization or need for increased treatments for COPD within 6 weeks prior to the Screening Period.
- Use of daily oxygen therapy > 10 hours per day.
- Use of systemic steroids within 3 months prior to the Screening Period.
- Respiratory tract infection within 6 weeks prior to or during the Screening Period.
- History of tuberculosis, bronchiectasis or other non-specific pulmonary disease.
- History of urinary retention or bladder neck obstruction type symptoms.
- History of narrow-angle glaucoma.
- Prolonged QTc interval (> 450msec for males and > 470msec for females) during the Screening Period, or history of long QT syndrome.
- Recent history (previous 12 months) of excessive use or abuse of narcotic/illegal drugs.
- History of hypersensitivity or intolerance to β2-agonists or anticholinergics.
- Participation in another investigational drug study where drug was received within 30 days prior to the Screening Period.
- Female subject who is pregnant or lactating
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 |
|---|---|
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Comparador de Placebo: EP-101 Placebo
EP-101 Placebo AM + EP-101 Placebo PM
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EP-101 Placebo AM + EP-101 Placebo PM
Outros nomes:
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Experimental: EP 101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
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EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
Outros nomes:
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Experimental: EP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
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EP-101 25 mcg AM + EP-101 25 mcg PM
Outros nomes:
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Experimental: EP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
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EP-101 50 mcg AM + EP-101 50 mcg PM
Outros nomes:
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Experimental: EP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM
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EP-101 100 mcg AM + EP-101 100 mcg PM
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
Prazo: Baseline and Day 29
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Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Trough FEV1 was defined as the mean of the spirometry values collected at 23 hours 30 minutes and 24 hours after the in-clinic morning dose (i.e.
approximately 12 hrs after the previous evening dose).
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Baseline and Day 29
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The Standardized Change From Baseline FEV1 AUC(0-12)
Prazo: Day 28
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Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
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Day 28
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The Standardized Change From Baseline FEV1 AUC(12-24)
Prazo: Day 28
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Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
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Day 28
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The Peak FEV1 Change From Baseline
Prazo: Day 28
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Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Peak FEV1 is defined as the highest postdose FEV1 value within 4 hrs after the morning dose.
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Day 28
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The Number of Subjects With Treatment-emergent Adverse Events
Prazo: Baseline up to Day 28
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Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
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Baseline up to Day 28
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The Number of Subjects With Treatment-emergent Serious Adverse Events
Prazo: Baseline up to Day 28
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Treatment-emergent serious adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
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Baseline up to Day 28
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The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
Prazo: Baseline up to Day 28
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Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
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Baseline up to Day 28
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The Percentage of Subjects With Treatment-emergent Adverse Events
Prazo: Baseline up to Day 28
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Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
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Baseline up to Day 28
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The Percentage of Subjects With Treatment-emergent Serious Adverse Events
Prazo: Baseline up to Day 28
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Treatment-emergent serious adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
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Baseline up to Day 28
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The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
Prazo: Baseline up to Day 28
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Treatment-emergent adverse events were those which first occurred or increased in severity or relationship to study drug after the first dose of double-blind study drug.
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Baseline up to Day 28
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Respiratory Medical Director, MD, Sunovion Respiratory Development
Publicações e links úteis
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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 outubro de 2012
Conclusão Primária (Real)
1 de abril de 2013
Conclusão do estudo (Real)
1 de abril de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
10 de outubro de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de outubro de 2012
Primeira postagem (Estimativa)
15 de outubro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de março de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de fevereiro de 2018
Última verificação
1 de fevereiro de 2018
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EP-101-04 (SUN101)
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