Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema (EMPHASIS)
3 de março de 2017 atualizado 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.
Visão geral do estudo
Status
Rescindido
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
84
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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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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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
40 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
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: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador de Placebo: 2 Placebo
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change From Baseline to Week 104 in Trough Forced Expiratory Volume in 1 Second (FEV1)
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percent Change From Baseline in Trough FEV1 From Baseline to Week 104
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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])
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
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 março de 2009
Conclusão Primária (Real)
1 de julho de 2015
Conclusão do estudo (Real)
1 de agosto de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
31 de março de 2009
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de abril de 2009
Primeira postagem (Estimativa)
2 de abril de 2009
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de abril de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de março de 2017
Última verificação
1 de março de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 197-08-250
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