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 febrero de 2018 actualizado 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Actual)
275
Fase
- Fase 2
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
-
-
Alabama
-
Jasper, Alabama, Estados Unidos, 35501
- Jasper Summit Research, LLC
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85006
- Pulmonary Associates, PA
-
-
California
-
Fullerton, California, Estados Unidos, 92835
- California Research Medical Group, Inc.
-
Los Angeles, California, Estados Unidos, 90095
- UCLA David Geffen School of Medicine
-
Riverside, California, Estados Unidos, 92506
- Integrated Research Group
-
Sacramento, California, Estados Unidos, 95819
- Capital Allergy & Respiratory Disease Center
-
San Diego, California, Estados Unidos, 92120
- Institute of HealthCare Assessment, Inc.
-
-
Florida
-
Clearwater, Florida, Estados Unidos, 33765
- Clinical Research of West Florida
-
Tampa, Florida, Estados Unidos, 33603
- Clinical Research of West Florida
-
-
Georgia
-
Austell, Georgia, Estados Unidos, 30106
- Georgia Clinical Research
-
Lawrenceville, Georgia, Estados Unidos, 30046
- Gwinnett Biomedical Research
-
-
Kansas
-
Topeka, Kansas, Estados Unidos, 66606
- Veritas Clinical Specialities, LTD
-
-
Minnesota
-
Minneapolis, Minnesota, Estados Unidos, 55407
- Minnesota Lung Center
-
-
North Carolina
-
Charlotte, North Carolina, Estados Unidos, 28207
- American Health Research
-
Raleigh, North Carolina, Estados Unidos, 27607
- North Carolina Clinical Research
-
-
Ohio
-
Cincinnati, Ohio, Estados Unidos, 45242
- New Horizons Clinical Research
-
-
Oregon
-
Medford, Oregon, Estados Unidos, 97504
- Clinical Research Institute of Southern Oregon, PC
-
Medford, Oregon, Estados Unidos, 97504
- Sunstone Medical Research LLC
-
Portland, Oregon, Estados Unidos, 97202
- Allergy Associates Research Center
-
-
South Carolina
-
Greenville, South Carolina, Estados Unidos, 29615
- Upstate Pharmaceutical Research
-
Greenville, South Carolina, Estados Unidos, 29615
- Greenville Pharmaceutical Research, Inc
-
Spartanburg, South Carolina, Estados Unidos, 29303
- South Carolina Pharmaceutical Research
-
Union, South Carolina, Estados Unidos, 29379
- CU Pharmacuetical Research
-
-
Texas
-
Houston, Texas, Estados Unidos, 77030
- Baylor College of Medicine
-
New Braunfels, Texas, Estados Unidos, 78130
- Central Texas Health Research
-
-
Virginia
-
Richmond, Virginia, Estados Unidos, 23225
- Pulmonary Associates of Richmond, Inc.
-
-
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
35 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
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: EP-101 Placebo
EP-101 Placebo AM + EP-101 Placebo PM
|
EP-101 Placebo AM + EP-101 Placebo PM
Otros nombres:
|
|
Experimental: EP 101 12.5 mcg
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
|
EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
Otros nombres:
|
|
Experimental: EP-101 25 mcg
EP-101 25 mcg AM + EP-101 25 mcg PM
|
EP-101 25 mcg AM + EP-101 25 mcg PM
Otros nombres:
|
|
Experimental: EP-101 50 mcg
EP-101 50 mcg AM + EP-101 50 mcg PM
|
EP-101 50 mcg AM + EP-101 50 mcg PM
Otros nombres:
|
|
Experimental: EP-101 100 mcg
EP-101 100 mcg AM + EP-101 100 mcg PM
|
EP-101 100 mcg AM + EP-101 100 mcg PM
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)
Periodo de tiempo: Baseline and Day 29
|
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).
|
Baseline and Day 29
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The Standardized Change From Baseline FEV1 AUC(0-12)
Periodo de tiempo: Day 28
|
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
|
Day 28
|
|
The Standardized Change From Baseline FEV1 AUC(12-24)
Periodo de tiempo: Day 28
|
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
|
Day 28
|
|
The Peak FEV1 Change From Baseline
Periodo de tiempo: Day 28
|
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.
|
Day 28
|
|
The Number of Subjects With Treatment-emergent Adverse Events
Periodo de tiempo: Baseline up to Day 28
|
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.
|
Baseline up to Day 28
|
|
The Number of Subjects With Treatment-emergent Serious Adverse Events
Periodo de tiempo: Baseline up to Day 28
|
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.
|
Baseline up to Day 28
|
|
The Number of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
Periodo de tiempo: Baseline up to Day 28
|
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.
|
Baseline up to Day 28
|
|
The Percentage of Subjects With Treatment-emergent Adverse Events
Periodo de tiempo: Baseline up to Day 28
|
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.
|
Baseline up to Day 28
|
|
The Percentage of Subjects With Treatment-emergent Serious Adverse Events
Periodo de tiempo: Baseline up to Day 28
|
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.
|
Baseline up to Day 28
|
|
The Percentage of Subjects With Treatment-emergent Adverse Events Leading to Study Medication Discontinuation
Periodo de tiempo: Baseline up to Day 28
|
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.
|
Baseline up to Day 28
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Respiratory Medical Director, MD, Sunovion Respiratory Development
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.
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 octubre de 2012
Finalización primaria (Actual)
1 de abril de 2013
Finalización del estudio (Actual)
1 de abril de 2013
Fechas de registro del estudio
Enviado por primera vez
10 de octubre de 2012
Primero enviado que cumplió con los criterios de control de calidad
10 de octubre de 2012
Publicado por primera vez (Estimar)
15 de octubre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de marzo de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
6 de febrero de 2018
Última verificación
1 de febrero de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EP-101-04 (SUN101)
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. .