Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema (EMPHASIS)
2017년 3월 3일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
84
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- UAB Lung Health Center
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California
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Torrance, California, 미국, 90502
- Los Angeles Biomedical Institute
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Florida
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Kissimmee, Florida, 미국, 34741
- Pulmonary Disease Specialist/PDS Research
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Miami, Florida, 미국, 33143
- Well Pharma Medical Research
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Winter Park, Florida, 미국, 32789
- Florida Premier Research Institute
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Georgia
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Austell, Georgia, 미국, 30106
- Georgia Clinical Research
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Illinois
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Peoria, Illinois, 미국, 61606
- Illinios Lung Institute
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Kentucky
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Louisville, Kentucky, 미국, 40202
- University of Louisville, Pulmonary Division
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Nebraska
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Omaha, Nebraska, 미국, 68198
- University of Nebraska Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19140
- Temple University Hospital
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South Carolina
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Spartanburg, South Carolina, 미국, 29303
- Spartanburg Medical Research
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Texas
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Houston, Texas, 미국, 77034
- Texas Institute of Chest and Sleep Disorders, PA
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San Antonio, Texas, 미국, 78229
- Diagnostics Research Group
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Virginia
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Richmond, Virginia, 미국, 23225
- Pulmonary Associates of Richmond
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Washington
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Tacoma, Washington, 미국, 98405
- Multicare Pulmonary Specialist
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
40년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 2 위약
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Placebo for 104 weeks (2 years)
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change From Baseline to Week 104 in Trough Forced Expiratory Volume in 1 Second (FEV1)
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percent Change From Baseline in Trough FEV1 From Baseline to Week 104
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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])
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2009년 3월 1일
기본 완료 (실제)
2015년 7월 1일
연구 완료 (실제)
2015년 8월 1일
연구 등록 날짜
최초 제출
2009년 3월 31일
QC 기준을 충족하는 최초 제출
2009년 4월 1일
처음 게시됨 (추정)
2009년 4월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 4월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 3월 3일
마지막으로 확인됨
2017년 3월 1일
추가 정보
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