Trial · NCT02006576
Prostaglandin Inhibition for Emphysema
NCT02006576, Phase 2, Completed, University of Nebraska; results first posted 2019-12-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Prostaglandin Inhibition for Emphysema. Trials, record NCT02006576. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02006576
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prostaglandin Inhibition for Emphysema
- NCT number
- NCT02006576
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 118 participants, actual
- Lead sponsor
- University of Nebraska
- Conditions
- Emphysema
- Interventions
- 600 mg ibuprofen three times daily for 48 weeks, Placebo three times daily
- First posted
- 2013-12-10
- Last updated
- 2023-12-13
- Results first posted
- 2019-12-16
Source ClinicalTrials.gov
Registered outcomes34
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Will Ibuprofen, 600 mg Three Times Daily, Decrease PGE Concentration in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo? | 12 weeks after subject randomization | PGE will be measured by HPLC in alveolar fluids obtained at randomization (week 0) and again 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. |
| Secondary | Will Ibuprofen, 600 mg Three Times Daily, Increase Pro-collagen Peptide Fragment Concentrations in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo? | 12 weeks after subject randomization | Pro-collagen peptide fragments will be measured by ELISA in alveolar fluids obtained at randomization (week 0) and again 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. |
| Other | Prostaglandin E Concentrations n Participants With Emphysema v in Smoking, Former Smoking and Healthy Non-smoking Controls After Ibuprofen Three Times Daily | 12 weeks after subject randomization | Comparing ibuprofen, 600 mg three times daily, in reducing prostaglandin E concentrations in the alveolar portion of bronchoalveolar lavage (BAL) fluid in participants with emphysema to those present in smoking, former smoking and healthy non-smoking controls? Prostaglandin E (PGE) will be measured by HPLC in alveolar fluids obtained at randomization and again 12 weeks after randomization on subjects taking ibuprofen to compare emphysema subjects, smokers, former smokers and controls. |
| Other | Will Ibuprofen 600 mg Three Times Daily, Reduce Prostaglandin E Concentrations in the Bronchial Portion of BAL Fluid in Subjects With Emphysema Compared to Placebo? | 12 weeks after subject randomization | PGE will be measured by HPLC in bronchial fluids obtained at randomization and again 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls. |
| Other | Will Ibuprofen 600 mg Three Times Daily, Reduce Prostaglandin E Concentrations in Induced Sputum From Subjects With Emphysema Compared to Placebo? | 10 weeks after subject randomization | PGE will be measured by HPLC in sputum samples obtained prior to randomization and again 10 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smokers and controls. |
| Other | Will Ibuprofen 600 mg Three Times Daily, Reduce the PGE Metabolite PGEM in the Peripheral Blood of Subjects With Emphysema Compared to Placebo? | 48 weeks after randomization | PGEM will be measured by HPLC in peripheral blood specimens obtained at randomization, 12 weeks after randomization and 48 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls. |
| Other | Will Ibuprofen 600 mg Three Times Daily, Reduce the PGE Metabolite PGEM in the Urine of Subjects With Emphysema Compared to Placebo? | 48 weeks after randomization | PGEM will be measured by HPLC in urine specimens obtained at randomization, 12 weeks after randomization and 48 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls. |
| Other | Will Ibuprofen, 600 mg Three Times Daily, Increase Pro-collagen Peptide Fragment Concentrations in the Alveolar Portion of BAL Fluid in Subjects to the Range Observed in Normal Individuals or to Higher Levels? | 12 weeks after randomization | Pro-collagen peptide fragment concentrations will be measured by ELISA in alveolar fluids obtained at randomization and again 12 weeks after randomization to determine if levels reach those of normal individuals or reach even higher levels. |
| Other | Will Ibuprofen 600 mg Three Times Daily, Increase the Procollagen III Amino Peptide Excreted Into the Urine of Subjects With Emphysema Compared to Placebo? | 48 weeks after randomization | Procollagen III amino peptide will be measured by ELISA in urine specimens obtained at randomization, 12 weeks after randomization and 48 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. |
| Other | Will Ibuprofen, 600 mg Three Times Daily, Decrease IL-8 Concentrations in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo? | 12 weeks after randomization | IL-8 will be measured by ELISA in alveolar specimens obtained at randomization and 12 weeks after randomization on emphysema subjects taking placebo and emphysema subjects taking ibuprofen to compare control group versus treatment group. The emphysema group will also be compared to smokers, former smoker, and controls. |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 registered outcomesOutcomes34
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Will Ibuprofen, 600 mg Three Times Daily, Decrease PGE Concentration in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo? | 12 weeks after subject randomization | Primary analysis limited to COPD Placebo vs. Ibuprofen groups only. The 'control' group is assessed once and serves as a comparator for the post treatment ibuprofen group. | Change in ng/ml | MEAN |
| SECONDARY | Will Ibuprofen, 600 mg Three Times Daily, Increase Pro-collagen Peptide Fragment Concentrations in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo? | 12 weeks after subject randomization | This analysis limited to COPD Placebo vs. Ibuprofen groups only. | Change in ng/ml | MEAN |
| OTHER_PRE_SPECIFIED | Prostaglandin E Concentrations n Participants With Emphysema v in Smoking, Former Smoking and Healthy Non-smoking Controls After Ibuprofen Three Times Daily | 12 weeks after subject randomization | |||
| OTHER_PRE_SPECIFIED | Will Ibuprofen 600 mg Three Times Daily, Reduce Prostaglandin E Concentrations in the Bronchial Portion of BAL Fluid in Subjects With Emphysema Compared to Placebo? | 12 weeks after subject randomization | |||
| OTHER_PRE_SPECIFIED | Will Ibuprofen 600 mg Three Times Daily, Reduce Prostaglandin E Concentrations in Induced Sputum From Subjects With Emphysema Compared to Placebo? | 10 weeks after subject randomization | |||
| OTHER_PRE_SPECIFIED | Will Ibuprofen 600 mg Three Times Daily, Reduce the PGE Metabolite PGEM in the Peripheral Blood of Subjects With Emphysema Compared to Placebo? | 48 weeks after randomization | |||
| OTHER_PRE_SPECIFIED | Will Ibuprofen 600 mg Three Times Daily, Reduce the PGE Metabolite PGEM in the Urine of Subjects With Emphysema Compared to Placebo? | 48 weeks after randomization | |||
| OTHER_PRE_SPECIFIED | Will Ibuprofen, 600 mg Three Times Daily, Increase Pro-collagen Peptide Fragment Concentrations in the Alveolar Portion of BAL Fluid in Subjects to the Range Observed in Normal Individuals or to Higher Levels? | 12 weeks after randomization | |||
| OTHER_PRE_SPECIFIED | Will Ibuprofen 600 mg Three Times Daily, Increase the Procollagen III Amino Peptide Excreted Into the Urine of Subjects With Emphysema Compared to Placebo? | 48 weeks after randomization | |||
| OTHER_PRE_SPECIFIED | Will Ibuprofen, 600 mg Three Times Daily, Decrease IL-8 Concentrations in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo? | 12 weeks after randomization |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 outcomesResults by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Will Ibuprofen, 600 mg Three Times Daily, Decrease PGE Concentration in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo? | COPD, Placebo | 0.003 | Standard Deviation 0.080 | Change in ng/ml | |
| Will Ibuprofen, 600 mg Three Times Daily, Decrease PGE Concentration in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo? | COPD, Ibuprofen | -0.156 | Standard Deviation 0.455 | Change in ng/ml | |
| Will Ibuprofen, 600 mg Three Times Daily, Increase Pro-collagen Peptide Fragment Concentrations in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo? | COPD, Placebo | -1.060 | Standard Deviation 8.729 | Change in ng/ml | |
| Will Ibuprofen, 600 mg Three Times Daily, Increase Pro-collagen Peptide Fragment Concentrations in the Alveolar Portion of BAL Fluid in Subjects With Emphysema in Comparison to Placebo? | COPD, Ibuprofen | 0.011 | Standard Deviation 0.584 | Change in ng/ml |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | COPD, Placebo | 35 | |
| Overall Study | STARTED | Control Subject | 51 | |
| Overall Study | STARTED | COPD, Ibuprofen | 32 | |
| Overall Study | COMPLETED | COPD, Placebo | 17 | |
| Overall Study | COMPLETED | Control Subject | 44 | |
| Overall Study | COMPLETED | COPD, Ibuprofen | 15 | |
| Overall Study | NOT COMPLETED | COPD, Placebo | 18 | |
| Overall Study | NOT COMPLETED | Control Subject | 7 | |
| Overall Study | NOT COMPLETED | COPD, Ibuprofen | 17 |
Source ClinicalTrials.gov
Adverse events48
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 | COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | COPD, Placebo | 1 | 35 | 2 |
| other | COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | Control Subject | 0 | 51 | 0 |
| other | COPD Exacerbation | Respiratory, thoracic and mediastinal disorders | COPD, Ibuprofen | 2 | 32 | 2 |
| other | Headache | General disorders | COPD, Placebo | 1 | 35 | 1 |
| other | Headache | General disorders | Control Subject | 0 | 51 | 0 |
| other | Headache | General disorders | COPD, Ibuprofen | 1 | 32 | 1 |
| other | Pneumonis | Respiratory, thoracic and mediastinal disorders | COPD, Placebo | 1 | 35 | 1 |
| other | Pneumonis | Respiratory, thoracic and mediastinal disorders | Control Subject | 0 | 51 | 0 |
| other | Pneumonis | Respiratory, thoracic and mediastinal disorders | COPD, Ibuprofen | 0 | 32 | 0 |
| other | Positive Occult Blood | Blood and lymphatic system disorders | COPD, Placebo | 0 | 35 | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | COPD, Placebo | 0 | 35 |
| Total, all-cause mortality | Control Subject | 0 | 51 |
| Total, all-cause mortality | COPD, Ibuprofen | 1 | 32 |
| Total, other adverse events | COPD, Placebo | 4 | 35 |
| Total, other adverse events | Control Subject | 0 | 51 |
| Total, other adverse events | COPD, Ibuprofen | 11 | 32 |
| Total, serious adverse events | COPD, Placebo | 4 | 35 |
| Total, serious adverse events | Control Subject | 0 | 51 |
| Total, serious adverse events | COPD, Ibuprofen | 2 | 32 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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The record and each of its lists are JSON, twenty rows a page. No key.
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