Trial · NCT00874497
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| 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. |
| Secondary | Change From Baseline to Week 104 in Trough Functional Residual Capacity (FRCpleth) | Baseline to Week 104 | Change from baseline in trough FRCpleth is presented in the below outcome data table. |
| Secondary | Change From Baseline to Week 104 in Carbon Monoxide Diffusion Capacity (DLco) | Baseline to Week 104 | Change from Baseline in DLco is presented in the below outcome data table. |
| Secondary | Change From Baseline to Week 104 in Mean Specific Airway Resistance (sRaw) and Specific Conductance (sGaw) | Baseline to Week 104 | Change from baseline in sRaw and sGaw is presented in the below outcome data table. |
| Secondary | Change From Baseline to Week 104 in 7-day Average Total Symptom Score of Dyspnea, Cough and Sputum | Baseline to Week 104 | 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). |
| Secondary | Change From Baseline to Week 104 in 7-day Mean Number of Actuations of Rescue Medications | Baseline to Week 104 | Participants recorded rescue medication use (albuterol and/or ipratropium bromide) in a rescue medication log. |
| Secondary | Percentage of Participants With COPD Exacerbations by Group at Week 104 | Baseline and Week 104 | 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). |
| Secondary | Percentage of Participants Experiencing a COPD Exacerbation (Level 2 or Higher) | Baseline and Week 104 | Percentage of participants experiencing a COPD exacerbation in a level 2 or higher are presented in the below outcome data table. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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