Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema (EMPHASIS)
3 de marzo de 2017 actualizado por: Otsuka Pharmaceutical Development & Commercialization, Inc.
A Multi-center, Randomized, Double-blind, Placebo-controlled Pilot Study to Assess the Pharmacodynamics, Efficacy and Safety of 50 mg Tetomilast Administered as Oral Tablets in Patients With Chronic Obstructive Pulmonary Disease Associated With Emphysema THIS STUDY IS CLOSED TO ENROLLMENT AND NEW SITES
Phase 2a multicenter, randomized, double-blind, placebo-controlled study to assess the pharmacodynamics, efficacy, and safety of tetomilast in patients with emphysema.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
84
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
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294
- UAB Lung Health Center
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California
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Torrance, California, Estados Unidos, 90502
- Los Angeles Biomedical Institute
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Florida
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Kissimmee, Florida, Estados Unidos, 34741
- Pulmonary Disease Specialist/PDS Research
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Miami, Florida, Estados Unidos, 33143
- Well Pharma Medical Research
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Winter Park, Florida, Estados Unidos, 32789
- Florida Premier Research Institute
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Georgia
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Austell, Georgia, Estados Unidos, 30106
- Georgia Clinical Research
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Illinois
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Peoria, Illinois, Estados Unidos, 61606
- Illinios Lung Institute
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40202
- University of Louisville, Pulmonary Division
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68198
- University of Nebraska Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19140
- Temple University Hospital
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South Carolina
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Spartanburg, South Carolina, Estados Unidos, 29303
- Spartanburg Medical Research
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Texas
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Houston, Texas, Estados Unidos, 77034
- Texas Institute of Chest and Sleep Disorders, PA
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San Antonio, Texas, Estados Unidos, 78229
- Diagnostics Research Group
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Virginia
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Richmond, Virginia, Estados Unidos, 23225
- Pulmonary Associates of Richmond
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Washington
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Tacoma, Washington, Estados Unidos, 98405
- Multicare Pulmonary Specialist
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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
40 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Male or female, 40-75 yrs old,inclusive.
- Rating of greater than or equal to 1 on the Goddard scale in assessment of emphysema severity by HRCT.
- FEV1: FVC greater than 70% predicted.
- At least 1 documented COPD exacerbation within the past year but not within 8 weeks of randomization.
- Current or former smokers with a cigarette smoking history of at least 20 pack-years (or equivalent) and whose smoking status has not changed 60 days prior to screening.
Exclusion Criteria:
- Patients with asthma, active tuberculosis or bronchiectasis.
- A respiratory tract infection within 30 days prior to the screening visit.
- Any malignancy within the last 5 years with the exception of non-melanomatous skin cancer.
- Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders.
- Uncontrolled condition with COPD exacerbation of level 2 or 3 in the 8-week period prior to randomization.
- Systemic use of corticosteroids or other immunosuppressive agents within 30 days of the screening visit.
- Subjects taking anticoagulants.
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: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: 2 placebos
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Placebo for 104 weeks (2 years)
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Experimental: 1 Tetomilast
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Oral tetomilast 25 mg once daily for 2 weeks followed by 50 mg once daily for 2 years.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline to Week 104 in Trough Forced Expiratory Volume in 1 Second (FEV1)
Periodo de tiempo: Baseline to Week 104
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The analysis of the change from Baseline to Week 104 (last observation carried forward [LOCF]) in trough FEV1 is presented below.
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Baseline to Week 104
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Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels
Periodo de tiempo: Baseline to Week 104
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The analysis of the change from Baseline to Week 104 (LOCF) in the 20th percentile of lung density voxels (expressed in Hounsfield unit [HU] using quantitative HCRT) by visit and lung region is presented below.
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Baseline to Week 104
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percent Change From Baseline in Trough FEV1 From Baseline to Week 104
Periodo de tiempo: Baseline to Week 104
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The percent change for the pulmonary function tests (PFT) from baseline was calculated for each study week as follows: % change from baseline = ([value at Week X - value at baseline] /value at baseline) x 100.
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Baseline to Week 104
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Density Mask Score Based on Specified Thresholds Including -950 HU
Periodo de tiempo: Baseline and Week 104
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The density mask score is defined as the percentage of lung density voxels that lie below a specified threshold in the lung region of interest.
The higher the percentage of the participant's lung density voxels that lie below a specified threshold, the higher the level of the participant's emphysema in the lung region under consideration.
Changes in the density mask score was assessed using only a single density mask threshold of -950 HU.
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Baseline and Week 104
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Rate of Change in the 20th Percentile of Lung Density Voxels Expressed in HU Units for the Whole Lung (Whole Right + Whole Left) From Baseline to Week 104
Periodo de tiempo: Baseline to Week 104
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The rate of change in lung density was calculated as the change in the 20th percentile of lung density voxels divided by the duration between the dates of measurement (month or year) where applicable.
For example, if HRCT measurements are available over a span of 2 years, the annual rate of change was calculated as the difference over the 2 years divided by 2, where years between scans is given by years= floor(data of last scan - date of first scan + 1)/365.25.
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Baseline to Week 104
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Observed Rate of Change in Emphysema From Baseline to Week 104
Periodo de tiempo: Baseline to Week 104
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The level of emphysema (g/L) within in a lung region is defined as the value of the selected percentile (10th, 15th, or 20th) in HU + 1000.
The rate of change in the emphysema from baseline was calculated as the change in the level of emphysema from baseline to the specified visit divided by the time in years between the baseline and specified visit (i.e., [date of visit - date of baseline visit + 1]/365.25).
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Baseline to Week 104
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Change From Baseline to Week 104 in Cumulative Frequency of HU
Periodo de tiempo: Baseline and Week 104
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The area under the curve (AUC) is defined as the cumulative voxel frequency in HU (ie, the value of the density mask denominator).
Blood samples (4 mL) for pharmacokinetic analysis were collected for the determination of plasma OPC-6535 concentrations at Predose on Day 1 and Weeks 26, 52, 78 and 104.
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Baseline and Week 104
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Change From Baseline to Week 104 in Computed Tomography (CT) - Derived Lung Volumes (Total Lung Capacity [TLC] and Residual Volume [RV])
Periodo de tiempo: Baseline to Week 104
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Change from baseline in CT-derived lung volumes TLC and RV are presented in the below outcome data table.
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Baseline to Week 104
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Change From Baseline to Week 104 in Trough RV/TLC
Periodo de tiempo: Baseline to Week 104
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Change from Baseline in Trough RV/TLC is presented in the below outcome data table.
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Baseline to Week 104
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Change From Baseline to Week 104 in Trough Inspiratory Capacity
Periodo de tiempo: Baseline toWeek 104
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Change from Baseline in Trough Inspiratory Capacity is presented in the below outcome data table.
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Baseline toWeek 104
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Change From Baseline to Week 104 in Trough Functional Residual Capacity (FRCpleth)
Periodo de tiempo: Baseline to Week 104
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Change from baseline in trough FRCpleth is presented in the below outcome data table.
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Baseline to Week 104
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Change From Baseline to Week 104 in Carbon Monoxide Diffusion Capacity (DLco)
Periodo de tiempo: Baseline to Week 104
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Change from Baseline in DLco is presented in the below outcome data table.
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Baseline to Week 104
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Change From Baseline to Week 104 in Mean Specific Airway Resistance (sRaw) and Specific Conductance (sGaw)
Periodo de tiempo: Baseline to Week 104
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Change from baseline in sRaw and sGaw is presented in the below outcome data table.
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Baseline to Week 104
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Change From Baseline to Week 104 in 7-day Average Total Symptom Score of Dyspnea, Cough and Sputum
Periodo de tiempo: Baseline to Week 104
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Participants used the Breathlessness, Cough, and Sputum Scale (BCSS) as the diary to daily monitor and rate their symptoms of difficulty breathing, cough, and sputum.
The scale allows patients to rate each symptom on a scale of 0 (no difficultly for breathing and sputum, or unaware of coughing) to 4 (an almost constant problem for breathing and sputum, or almost constant for cough).
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Baseline to Week 104
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Change From Baseline to Week 104 in 7-day Mean Number of Actuations of Rescue Medications
Periodo de tiempo: Baseline to Week 104
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Participants recorded rescue medication use (albuterol and/or ipratropium bromide) in a rescue medication log.
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Baseline to Week 104
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Percentage of Participants With COPD Exacerbations by Group at Week 104
Periodo de tiempo: Baseline and Week 104
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For the COPD exacerbations, baseline is defined as Randomization (Day 1).
COPD exacerbations, defined as an acute worsening of COPD symptoms, were classified as being in one of 3 levels: Level I (can by self-managed by the participant); Level II (requires a physician visit), or Level III (requires a hospital visit).
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Baseline and Week 104
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Percentage of Participants Experiencing a COPD Exacerbation (Level 2 or Higher)
Periodo de tiempo: Baseline and Week 104
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Percentage of participants experiencing a COPD exacerbation in a level 2 or higher are presented in the below outcome data table.
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Baseline and Week 104
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este 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 marzo de 2009
Finalización primaria (Actual)
1 de julio de 2015
Finalización del estudio (Actual)
1 de agosto de 2015
Fechas de registro del estudio
Enviado por primera vez
31 de marzo de 2009
Primero enviado que cumplió con los criterios de control de calidad
1 de abril de 2009
Publicado por primera vez (Estimar)
2 de abril de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de abril de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
3 de marzo de 2017
Última verificación
1 de marzo de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 197-08-250
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. .