Trial · NCT00874497
Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema
NCT00874497, Phase 2, Terminated, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2017-04-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema. Trials, record NCT00874497. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00874497
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema
- NCT number
- NCT00874497
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 84 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- tetomilast, placebo
- First posted
- 2009-04-02
- Last updated
- 2017-04-17
- Results first posted
- 2017-04-17
- Limitations and caveats
- This trial was terminated early, not due to a safety concern, but due to a business decision to cease development of the tetolimast clinical program.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 104 in Trough Forced Expiratory Volume in 1 Second (FEV1) | Baseline to Week 104 | The analysis of the change from Baseline to Week 104 (last observation carried forward \[LOCF\]) in trough FEV1 is presented below. |
| Primary | Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels | Baseline to Week 104 | 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. |
| Secondary | Percent Change From Baseline in Trough FEV1 From Baseline to Week 104 | Baseline to Week 104 | 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. |
| Secondary | Density Mask Score Based on Specified Thresholds Including -950 HU | Baseline and Week 104 | 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. |
| Secondary | 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 | Baseline to Week 104 | 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. |
| Secondary | Observed Rate of Change in Emphysema From Baseline to Week 104 | Baseline to Week 104 | 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). |
| Secondary | Change From Baseline to Week 104 in Cumulative Frequency of HU | Baseline and Week 104 | 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. |
| Secondary | Change From Baseline to Week 104 in Computed Tomography (CT) - Derived Lung Volumes (Total Lung Capacity [TLC] and Residual Volume [RV]) | Baseline to Week 104 | Change from baseline in CT-derived lung volumes TLC and RV are presented in the below outcome data table. |
| Secondary | Change From Baseline to Week 104 in Trough RV/TLC | Baseline to Week 104 | Change from Baseline in Trough RV/TLC is presented in the below outcome data table. |
| Secondary | Change From Baseline to Week 104 in Trough Inspiratory Capacity | Baseline toWeek 104 | Change from Baseline in Trough Inspiratory Capacity is presented in the below outcome data table. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 104 in Trough Forced Expiratory Volume in 1 Second (FEV1) | Baseline to Week 104 | The Intent-to-Treat (ITT) population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable High-resolution computed tomography (HRCT) scan. | L | MEAN |
| PRIMARY | Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels | Baseline to Week 104 | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 43 and 25 respectively. | Hounsfield unit/year | MEAN |
| SECONDARY | Percent Change From Baseline in Trough FEV1 From Baseline to Week 104 | Baseline to Week 104 | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 28 and 18 respectively. | percentage change | MEAN |
| SECONDARY | Density Mask Score Based on Specified Thresholds Including -950 HU | Baseline and Week 104 | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 16 respectively. | Hounsfield unit | MEAN |
| SECONDARY | 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 | Baseline to Week 104 | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 46 and 26 respectively. | Hounsfield unit/year | MEAN |
| SECONDARY | Observed Rate of Change in Emphysema From Baseline to Week 104 | Baseline to Week 104 | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 16 respectively. | g/L | MEAN |
| SECONDARY | Change From Baseline to Week 104 in Cumulative Frequency of HU | Baseline and Week 104 | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 23 and 16 respectively. | Hounsfield unit*hour | MEAN |
| SECONDARY | Change From Baseline to Week 104 in Computed Tomography (CT) - Derived Lung Volumes (Total Lung Capacity [TLC] and Residual Volume [RV]) | Baseline to Week 104 | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 22 and 16 respectively. | mL | MEAN |
| SECONDARY | Change From Baseline to Week 104 in Trough RV/TLC | Baseline to Week 104 | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were n= 21 and 14 respectively. | unitless | MEAN |
| SECONDARY | Change From Baseline to Week 104 in Trough Inspiratory Capacity | Baseline toWeek 104 | The ITT population consisted of all randomized participants with non-missing baseline data and at least one post-baseline trough FEV1 measurement or evaluable HRCT scan. The number of participants analyzed at Week 104 were N = 25 and 14 respectively. | mL | MEAN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group140
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 104 in Trough Forced Expiratory Volume in 1 Second (FEV1) | Tetomilast 50 mg | -0.001 | Standard Deviation 0.2011 | L | |
| Change From Baseline to Week 104 in Trough Forced Expiratory Volume in 1 Second (FEV1) | Placebo | -0.083 | Standard Deviation 0.3241 | L | |
| Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels | Tetomilast 50 mg | Right Upper (n= 43, 25) | -2.639 | Standard Deviation 7.9744 | Hounsfield unit/year |
| Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels | Placebo | Right Upper (n= 43, 25) | 0.375 | Standard Deviation 7.1318 | Hounsfield unit/year |
| Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels | Tetomilast 50 mg | Right Middle (n= 43, 25) | -1.912 | Standard Deviation 6.0688 | Hounsfield unit/year |
| Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels | Placebo | Right Middle (n= 43, 25) | -0.831 | Standard Deviation 7.1709 | Hounsfield unit/year |
| Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels | Tetomilast 50 mg | Right Lower (n= 43, 25) | -1.884 | Standard Deviation 11.5558 | Hounsfield unit/year |
| Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels | Placebo | Right Lower (n= 43, 25) | 0.379 | Standard Deviation 11.0216 | Hounsfield unit/year |
| Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels | Tetomilast 50 mg | Left Upper (n= 43, 25) | -1.709 | Standard Deviation 9.8835 | Hounsfield unit/year |
| Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels | Placebo | Left Upper (n= 43, 25) | 0.686 | Standard Deviation 8.0797 | Hounsfield unit/year |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tetomilast 50 mg | 51 | |
| Overall Study | STARTED | Placebo | 33 | |
| Overall Study | COMPLETED | Tetomilast 50 mg | 23 | |
| Overall Study | COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | Tetomilast 50 mg | 28 | |
| Overall Study | NOT COMPLETED | Placebo | 18 |
Source ClinicalTrials.gov
Adverse events146
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukocytosis | Blood and lymphatic system disorders | Tetomilast 25 mg | 0 | 51 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo | 2 | 33 | |
| other | Palpitations | Cardiac disorders | Tetomilast 25 mg | 0 | 51 | |
| other | Palpitations | Cardiac disorders | Placebo | 2 | 33 | |
| other | Abdominal pain | Gastrointestinal disorders | Tetomilast 25 mg | 3 | 51 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 2 | 33 | |
| other | Constipation | Gastrointestinal disorders | Tetomilast 25 mg | 1 | 51 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 2 | 33 | |
| other | Diarrhoea | Gastrointestinal disorders | Tetomilast 25 mg | 5 | 51 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 33 |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tetomilast 25 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Tetomilast 25 mg | 30 | 51 |
| Total, other adverse events | Placebo | 23 | 33 |
| Total, serious adverse events | Tetomilast 25 mg | 13 | 51 |
| Total, serious adverse events | Placebo | 12 | 33 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Tetomilast 25 mg vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00874497
GET https://conductscience.org/api/trials/v1/NCT00874497/results?page=2