Trial · NCT03861390
Woodsmoke Particulate + Prednisone
NCT03861390, Phase 1, Phase 2, Completed, University of North Carolina, Chapel Hill; results first posted 2024-05-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Woodsmoke Particulate + Prednisone. Trials, record NCT03861390. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03861390
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Woodsmoke Particulate + Prednisone
- NCT number
- NCT03861390
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- University of North Carolina, Chapel Hill
- Conditions
- Airway Inflammation
- Interventions
- 60 mg Prednisone, Placebo
- First posted
- 2019-03-04
- Last updated
- 2024-06-25
- Results first posted
- 2024-05-23
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to 4 Hours in Sputum Percent Neutrophils | Baseline, 4 hours post WSP exposure | Change in sputum percent neutrophils from baseline to 4 hours post WSP exposure |
| Primary | Change From Baseline to 24 Hours in Sputum Percent Neutrophils | Baseline, 24 hours post WSP exposure | Change in sputum percent neutrophils from baseline to 24 hours post WSP exposure |
| Secondary | Change in Number of Sputum Neutrophils | Baseline, 4 and 24 hours post WSP exposure | Neutrophil numbers/mg measured at 4 and 24 hours post WSP exposure. Comparisons at 4 and 24 hours are each made with respect to Baseline. |
| Secondary | Change in Number of Sputum Eosinophils | Baseline, 4 and 24 hours post WSP exposure | Eosinophil numbers/mg measured at 4 and 24 hours post WSP exposure. Comparisons at 4 and 24 hours are each made with respect to Baseline. |
| Secondary | Change in Percent Sputum Eosinophils | Baseline, 4 and 24 hours post WSP exposure | Percent eosinophil measured at 4 and 24 hours post WSP exposure. Comparisons at 4 and 24 hours are each made with respect to Baseline. |
| Secondary | Change in IL-1b | Baseline, 4 and 24 hours post WSP exposure | Interleukin beta (IL-1b) via Mesoscale platform (pg/mL) at 4 and 24 hours post WSP exposure. Comparisons at 4 and 24 hours are each made with respect to Baseline. |
| Secondary | Change in IL-6 | Baseline, 4 and 24 hours post WSP exposure | Interleukin-6 (IL-6) via Mesoscale platform (pg/mL) at 4 and 24 hours post WSP exposure. Comparisons at 4 and 24 hours are each made with respect to Baseline. |
| Secondary | Change in IL-8 | Baseline, 4 and 24 hours post WSP exposure | Interleukin-8 (IL-8) via Mesoscale platform (pg/mL) at 4 and 24 hours post WSP exposure. Comparisons at 4 and 24 hours are each made with respect to Baseline. |
| Secondary | Change in TNFa | Baseline, 4 and 24 hours post WSP exposure | Tumor necrosis factor alpha (TNFa) via Mesoscale platform (pg/mL) at 4 and 24 hours post WSP exposure. Comparisons at 4 and 24 hours are each made with respect to Baseline. |
| Other | Mucociliary Clearance (MCC) | 4 hours post WSP exposure | 4 hours post WSP exposure, the MCC is done. A whole lung region of interest (ROI) bordering the right lung is used to estimate (by computer analysis) whole lung retention of inhaled radiolabeled particles. Labeled particle counts are measured over a 2 hour period to determine the fraction of initial particle counts remaining. From this data, the investigators will determine the percentage of labeled particles cleared from the lung during the 2 hour observation period. |
Source ClinicalTrials.gov
Outcomes10
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 4 Hours in Sputum Percent Neutrophils | Baseline, 4 hours post WSP exposure | Cell differential slide inadequate for 1 participant in prednisone arm; paired analysis drops this participant from analysis across both arms. | percent neutrophils | MEDIAN |
| PRIMARY | Change From Baseline to 24 Hours in Sputum Percent Neutrophils | Baseline, 24 hours post WSP exposure | Cell differential slide inadequate for 1 participant in prednisone arm; paired analysis drops this participant from analysis across both arms. | percent neutrophils | MEDIAN |
| SECONDARY | Change in Number of Sputum Neutrophils | Baseline, 4 and 24 hours post WSP exposure | Cell differential slide inadequate for 1 participant in prednisone arm; paired analysis drops this participant from analysis across both arms. | Neutrophils/mg | MEDIAN |
| SECONDARY | Change in Number of Sputum Eosinophils | Baseline, 4 and 24 hours post WSP exposure | Cell differential slide inadequate for 1 participant in prednisone arm; paired analysis drops this participant from analysis across both arms. | Eosinophils/mg | MEDIAN |
| SECONDARY | Change in Percent Sputum Eosinophils | Baseline, 4 and 24 hours post WSP exposure | Cell differential slide inadequate for 1 participant in prednisone arm; paired analysis drops this participant from analysis across both arms. | percent eosinophils | MEDIAN |
| SECONDARY | Change in IL-1b | Baseline, 4 and 24 hours post WSP exposure | An attempt was made to analyze samples for 12 participants; although some samples had insufficient quantity remaining. Data are reported for all samples that yielded data for each endpoint and at each time. | pg/mL | MEDIAN |
| SECONDARY | Change in IL-6 | Baseline, 4 and 24 hours post WSP exposure | An attempt was made to analyze samples for 12 participants; although some samples had insufficient quantity remaining. Data are reported for all samples that yielded data for each endpoint and at each time. | pg/mL | MEDIAN |
| SECONDARY | Change in IL-8 | Baseline, 4 and 24 hours post WSP exposure | An attempt was made to analyze samples for 12 participants; although some samples had insufficient quantity remaining. Data are reported for all samples that yielded data for each endpoint and at each time. | pg/mL | MEDIAN |
| SECONDARY | Change in TNFa | Baseline, 4 and 24 hours post WSP exposure | An attempt was made to analyze samples for 12 participants; although some samples had insufficient quantity remaining. Data are reported for all samples that yielded data for each endpoint and at each time. | pg/mL | MEDIAN |
| OTHER_PRE_SPECIFIED | Mucociliary Clearance (MCC) | 4 hours post WSP exposure |
Source ClinicalTrials.gov
Results by group32
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 4 Hours in Sputum Percent Neutrophils | Prednisone | -2.62 | Inter-Quartile Range -6.27 to 6.08 | percent neutrophils | |
| Change From Baseline to 4 Hours in Sputum Percent Neutrophils | Placebo | 5.45 | Inter-Quartile Range 1.21 to 8.79 | percent neutrophils | |
| Change From Baseline to 24 Hours in Sputum Percent Neutrophils | Prednisone | 8.07 | Inter-Quartile Range -0.34 to 26.00 | percent neutrophils | |
| Change From Baseline to 24 Hours in Sputum Percent Neutrophils | Placebo | 22.68 | Inter-Quartile Range 7.00 to 41.40 | percent neutrophils | |
| Change in Number of Sputum Neutrophils | Prednisone | 4 hours post WSP exposure | 52.00 | Inter-Quartile Range -120.00 to 76.00 | Neutrophils/mg |
| Change in Number of Sputum Neutrophils | Placebo | 4 hours post WSP exposure | 36.00 | Inter-Quartile Range -6.00 to 73.00 | Neutrophils/mg |
| Change in Number of Sputum Neutrophils | Prednisone | 24 hours post WSP exposure | -17.00 | Inter-Quartile Range -53.00 to 92.00 | Neutrophils/mg |
| Change in Number of Sputum Neutrophils | Placebo | 24 hours post WSP exposure | 37.00 | Inter-Quartile Range -13.00 to 143.00 | Neutrophils/mg |
| Change in Number of Sputum Eosinophils | Prednisone | 4 hours post WSP exposure | 0.00 | Inter-Quartile Range -0.5 to 2.00 | Eosinophils/mg |
| Change in Number of Sputum Eosinophils | Placebo | 4 hours post WSP exposure | 0.00 | Inter-Quartile Range 0.00 to 0.00 | Eosinophils/mg |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Prednisone, Then Placebo | 6 | |
| First Intervention | STARTED | Placebo, Then Prednisone | 6 | |
| First Intervention | COMPLETED | Prednisone, Then Placebo | 6 | |
| First Intervention | COMPLETED | Placebo, Then Prednisone | 6 | |
| First Intervention | NOT COMPLETED | Prednisone, Then Placebo | 0 | |
| First Intervention | NOT COMPLETED | Placebo, Then Prednisone | 0 | |
| Washout (4 Weeks) | STARTED | Prednisone, Then Placebo | 6 | |
| Washout (4 Weeks) | STARTED | Placebo, Then Prednisone | 6 | |
| Washout (4 Weeks) | COMPLETED | Prednisone, Then Placebo | 6 | |
| Washout (4 Weeks) | COMPLETED | Placebo, Then Prednisone | 6 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events26
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 | Bed bug infestation | Social circumstances | Prednisone | 1 | 12 | 1 |
| other | Bed bug infestation | Social circumstances | Placebo | 0 | 12 | 0 |
| other | Sweating | General disorders | Prednisone | 1 | 12 | 2 |
| other | Sweating | General disorders | Placebo | 2 | 12 | 5 |
| other | Runny nose | Respiratory, thoracic and mediastinal disorders | Prednisone | 1 | 12 | 2 |
| other | Runny nose | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 12 | 1 |
| other | Eye irritation | Eye disorders | Prednisone | 1 | 12 | 1 |
| other | Eye irritation | Eye disorders | Placebo | 1 | 12 | 1 |
| other | Headache | General disorders | Prednisone | 1 | 12 | 1 |
| other | Headache | General disorders | Placebo | 1 | 12 | 1 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prednisone | 0 | 12 |
| Total, all-cause mortality | Placebo | 0 | 12 |
| Total, other adverse events | Prednisone | 5 | 12 |
| Total, other adverse events | Placebo | 4 | 12 |
| Total, serious adverse events | Prednisone | 0 | 12 |
| Total, serious adverse events | Placebo | 0 | 12 |
Source ClinicalTrials.gov
Papers22
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Prednisone vs Placebo: deaths from any cause | Trial comparisons |
| Prednisone vs Placebo: serious adverse events | 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/NCT03861390
GET https://conductscience.org/api/trials/v1/NCT03861390/results?page=2