Trial Outcomes & Findings for Woodsmoke Particulate + Prednisone (NCT NCT03861390)
NCT ID: NCT03861390
Last Updated: 2024-06-25
Results Overview
Change in sputum percent neutrophils from baseline to 4 hours post WSP exposure
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Baseline, 4 hours post WSP exposure
Results posted on
2024-06-25
Participant Flow
Participant milestones
| Measure |
Prednisone, Then Placebo
Participants will receive prednisone following wood smoke particle (WSP) exposure. After a 4-week washout period, participants will receive placebo following WSP exposure.
60 mg Prednisone: Immediately following exit from the wood smoke chamber, subjects will receive 60 mg of prednisone per randomization schema
Placebo: Immediately following exit from the wood smoke chamber, subjects will receive a matching placebo to the 60 mg of prednisone per randomization schema
|
Placebo, Then Prednisone
Participants will receive placebo following wood smoke particle (WSP) exposure. After a 4-week washout period, participants will receive prednisone following WSP exposure.
60 mg Prednisone: Immediately following exit from the wood smoke chamber, subjects will receive 60 mg of prednisone per randomization schema
Placebo: Immediately following exit from the wood smoke chamber, subjects will receive a matching placebo to the 60 mg of prednisone per randomization schema
|
|---|---|---|
|
First Intervention
STARTED
|
6
|
6
|
|
First Intervention
COMPLETED
|
6
|
6
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Washout (4 Weeks)
STARTED
|
6
|
6
|
|
Washout (4 Weeks)
COMPLETED
|
6
|
6
|
|
Washout (4 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Period Title: Second Intervention
STARTED
|
6
|
6
|
|
Period Title: Second Intervention
COMPLETED
|
6
|
6
|
|
Period Title: Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Woodsmoke Particulate + Prednisone
Baseline characteristics by cohort
| Measure |
Prednisone, Then Placebo
n=6 Participants
Participants receive prednisone following WSP exposure. After a 4-week washout period, participants receive placebo following WSP exposure.
60 mg Prednisone: Immediately following exit from the wood smoke chamber, subjects receive 60 mg of prednisone per randomization schema
Placebo: Immediately following exit from the wood smoke chamber, subjects receive a matching placebo to the 60 mg of prednisone per randomization schema
|
Placebo, Then Prednisone
n=6 Participants
Participants receive placebo following WSP exposure. After a 4-week washout period, participants receive prednisone following WSP exposure.
60 mg Prednisone: Immediately following exit from the wood smoke chamber, subjects receive 60 mg of prednisone per randomization schema
Placebo: Immediately following exit from the wood smoke chamber, subjects receive a matching placebo to the 60 mg of prednisone per randomization schema
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 4 hours post WSP exposurePopulation: Cell differential slide inadequate for 1 participant in prednisone arm; paired analysis drops this participant from analysis across both arms.
Change in sputum percent neutrophils from baseline to 4 hours post WSP exposure
Outcome measures
| Measure |
Prednisone
n=11 Participants
Immediately following exit from the wood smoke chamber, subjects receive 60 mg of prednisone per randomization schema
|
Placebo
n=11 Participants
Immediately following exit from the wood smoke chamber, subjects receive a matching placebo to the 60 mg of prednisone per randomization schema
|
|---|---|---|
|
Change From Baseline to 4 Hours in Sputum Percent Neutrophils
|
-2.62 percent neutrophils
Interval -6.27 to 6.08
|
5.45 percent neutrophils
Interval 1.21 to 8.79
|
PRIMARY outcome
Timeframe: Baseline, 24 hours post WSP exposurePopulation: Cell differential slide inadequate for 1 participant in prednisone arm; paired analysis drops this participant from analysis across both arms.
Change in sputum percent neutrophils from baseline to 24 hours post WSP exposure
Outcome measures
| Measure |
Prednisone
n=11 Participants
Immediately following exit from the wood smoke chamber, subjects receive 60 mg of prednisone per randomization schema
|
Placebo
n=11 Participants
Immediately following exit from the wood smoke chamber, subjects receive a matching placebo to the 60 mg of prednisone per randomization schema
|
|---|---|---|
|
Change From Baseline to 24 Hours in Sputum Percent Neutrophils
|
8.07 percent neutrophils
Interval -0.34 to 26.0
|
22.68 percent neutrophils
Interval 7.0 to 41.4
|
SECONDARY outcome
Timeframe: Baseline, 4 and 24 hours post WSP exposurePopulation: Cell differential slide inadequate for 1 participant in prednisone arm; paired analysis drops this participant from analysis across both arms.
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.
Outcome measures
| Measure |
Prednisone
n=11 Participants
Immediately following exit from the wood smoke chamber, subjects receive 60 mg of prednisone per randomization schema
|
Placebo
n=11 Participants
Immediately following exit from the wood smoke chamber, subjects receive a matching placebo to the 60 mg of prednisone per randomization schema
|
|---|---|---|
|
Change in Number of Sputum Neutrophils
4 hours post WSP exposure
|
52.00 Neutrophils/mg
Interval -120.0 to 76.0
|
36.00 Neutrophils/mg
Interval -6.0 to 73.0
|
|
Change in Number of Sputum Neutrophils
24 hours post WSP exposure
|
-17.00 Neutrophils/mg
Interval -53.0 to 92.0
|
37.00 Neutrophils/mg
Interval -13.0 to 143.0
|
SECONDARY outcome
Timeframe: Baseline, 4 and 24 hours post WSP exposurePopulation: Cell differential slide inadequate for 1 participant in prednisone arm; paired analysis drops this participant from analysis across both arms.
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.
Outcome measures
| Measure |
Prednisone
n=11 Participants
Immediately following exit from the wood smoke chamber, subjects receive 60 mg of prednisone per randomization schema
|
Placebo
n=11 Participants
Immediately following exit from the wood smoke chamber, subjects receive a matching placebo to the 60 mg of prednisone per randomization schema
|
|---|---|---|
|
Change in Number of Sputum Eosinophils
4 hours post WSP exposure
|
0.00 Eosinophils/mg
Interval -0.5 to 2.0
|
0.00 Eosinophils/mg
Interval 0.0 to 0.0
|
|
Change in Number of Sputum Eosinophils
24 hours post WSP exposure
|
0.00 Eosinophils/mg
Interval -1.0 to 0.0
|
0.00 Eosinophils/mg
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline, 4 and 24 hours post WSP exposurePopulation: Cell differential slide inadequate for 1 participant in prednisone arm; paired analysis drops this participant from analysis across both arms.
Percent eosinophil measured at 4 and 24 hours post WSP exposure. Comparisons at 4 and 24 hours are each made with respect to Baseline.
Outcome measures
| Measure |
Prednisone
n=11 Participants
Immediately following exit from the wood smoke chamber, subjects receive 60 mg of prednisone per randomization schema
|
Placebo
n=11 Participants
Immediately following exit from the wood smoke chamber, subjects receive a matching placebo to the 60 mg of prednisone per randomization schema
|
|---|---|---|
|
Change in Percent Sputum Eosinophils
4 hours post WSP exposure
|
0.00 percent eosinophils
Interval 0.0 to 0.0
|
0.00 percent eosinophils
Interval -0.2 to 0.3
|
|
Change in Percent Sputum Eosinophils
24 hours post WSP exposure
|
0.00 percent eosinophils
Interval 0.0 to 0.0
|
0.00 percent eosinophils
Interval -0.2 to 0.2
|
SECONDARY outcome
Timeframe: Baseline, 4 and 24 hours post WSP exposurePopulation: 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.
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.
Outcome measures
| Measure |
Prednisone
n=12 Participants
Immediately following exit from the wood smoke chamber, subjects receive 60 mg of prednisone per randomization schema
|
Placebo
n=12 Participants
Immediately following exit from the wood smoke chamber, subjects receive a matching placebo to the 60 mg of prednisone per randomization schema
|
|---|---|---|
|
Change in IL-1b
4 hours post WSP exposure
|
39.60 pg/mL
Interval -124.0 to 194.0
|
-41.80 pg/mL
Interval -634.0 to 148.0
|
|
Change in IL-1b
24 hours post WSP exposure
|
357.00 pg/mL
Interval 16.6 to 546.0
|
128.00 pg/mL
Interval -461.0 to 197.0
|
SECONDARY outcome
Timeframe: Baseline, 4 and 24 hours post WSP exposurePopulation: 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.
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.
Outcome measures
| Measure |
Prednisone
n=12 Participants
Immediately following exit from the wood smoke chamber, subjects receive 60 mg of prednisone per randomization schema
|
Placebo
n=12 Participants
Immediately following exit from the wood smoke chamber, subjects receive a matching placebo to the 60 mg of prednisone per randomization schema
|
|---|---|---|
|
Change in IL-6
4 hours post WSP exposure
|
52.78 pg/mL
Interval -310.4 to 231.2
|
80.35 pg/mL
Interval -131.3 to 472.0
|
|
Change in IL-6
24 hours post WSP exposure
|
37.69 pg/mL
Interval -123.0 to 509.0
|
0.00 pg/mL
Interval -494.6 to 194.1
|
SECONDARY outcome
Timeframe: Baseline, 4 and 24 hours post WSP exposurePopulation: 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.
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.
Outcome measures
| Measure |
Prednisone
n=12 Participants
Immediately following exit from the wood smoke chamber, subjects receive 60 mg of prednisone per randomization schema
|
Placebo
n=12 Participants
Immediately following exit from the wood smoke chamber, subjects receive a matching placebo to the 60 mg of prednisone per randomization schema
|
|---|---|---|
|
Change in IL-8
4 hours post WSP exposure
|
1416.00 pg/mL
Interval -2161.0 to 7096.0
|
869.00 pg/mL
Interval -11445.0 to 3866.0
|
|
Change in IL-8
24 hours post WSP exposure
|
4835.00 pg/mL
Interval -2007.0 to 17149.0
|
627.00 pg/mL
Interval -6788.0 to 8724.0
|
SECONDARY outcome
Timeframe: Baseline, 4 and 24 hours post WSP exposurePopulation: 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.
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.
Outcome measures
| Measure |
Prednisone
n=12 Participants
Immediately following exit from the wood smoke chamber, subjects receive 60 mg of prednisone per randomization schema
|
Placebo
n=12 Participants
Immediately following exit from the wood smoke chamber, subjects receive a matching placebo to the 60 mg of prednisone per randomization schema
|
|---|---|---|
|
Change in TNFa
24 hours post WSP exposure
|
17.70 pg/mL
Interval -17.8 to 115.0
|
0.00 pg/mL
Interval -237.0 to 73.1
|
|
Change in TNFa
4 hours post WSP exposure
|
-3.63 pg/mL
Interval -85.5 to 3.45
|
0.00 pg/mL
Interval -119.0 to 265.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 hours post WSP exposure4 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.
Outcome measures
Outcome data not reported
Adverse Events
Prednisone
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prednisone
n=12 participants at risk
Immediately following exit from the wood smoke chamber, subjects receive 60 mg of prednisone per randomization schema
|
Placebo
n=12 participants at risk
Immediately following exit from the wood smoke chamber, subjects receive a matching placebo to the 60 mg of prednisone per randomization schema
|
|---|---|---|
|
Social circumstances
Bed bug infestation
|
8.3%
1/12 • Number of events 1 • From the time of signing informed consent through study completion, approximately 3 months.
|
0.00%
0/12 • From the time of signing informed consent through study completion, approximately 3 months.
|
|
General disorders
Sweating
|
8.3%
1/12 • Number of events 2 • From the time of signing informed consent through study completion, approximately 3 months.
|
16.7%
2/12 • Number of events 5 • From the time of signing informed consent through study completion, approximately 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
8.3%
1/12 • Number of events 2 • From the time of signing informed consent through study completion, approximately 3 months.
|
8.3%
1/12 • Number of events 1 • From the time of signing informed consent through study completion, approximately 3 months.
|
|
Eye disorders
Eye irritation
|
8.3%
1/12 • Number of events 1 • From the time of signing informed consent through study completion, approximately 3 months.
|
8.3%
1/12 • Number of events 1 • From the time of signing informed consent through study completion, approximately 3 months.
|
|
General disorders
Headache
|
8.3%
1/12 • Number of events 1 • From the time of signing informed consent through study completion, approximately 3 months.
|
8.3%
1/12 • Number of events 1 • From the time of signing informed consent through study completion, approximately 3 months.
|
|
General disorders
Dry throat
|
25.0%
3/12 • Number of events 6 • From the time of signing informed consent through study completion, approximately 3 months.
|
8.3%
1/12 • Number of events 1 • From the time of signing informed consent through study completion, approximately 3 months.
|
|
General disorders
Sore throat
|
25.0%
3/12 • Number of events 6 • From the time of signing informed consent through study completion, approximately 3 months.
|
8.3%
1/12 • Number of events 1 • From the time of signing informed consent through study completion, approximately 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Drop in FEV1 following sputum induction
|
8.3%
1/12 • Number of events 1 • From the time of signing informed consent through study completion, approximately 3 months.
|
0.00%
0/12 • From the time of signing informed consent through study completion, approximately 3 months.
|
|
Cardiac disorders
High heart rate alarm
|
0.00%
0/12 • From the time of signing informed consent through study completion, approximately 3 months.
|
8.3%
1/12 • Number of events 1 • From the time of signing informed consent through study completion, approximately 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Irritation of the nose
|
8.3%
1/12 • Number of events 1 • From the time of signing informed consent through study completion, approximately 3 months.
|
0.00%
0/12 • From the time of signing informed consent through study completion, approximately 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Stuffy nose
|
8.3%
1/12 • Number of events 1 • From the time of signing informed consent through study completion, approximately 3 months.
|
0.00%
0/12 • From the time of signing informed consent through study completion, approximately 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
8.3%
1/12 • Number of events 1 • From the time of signing informed consent through study completion, approximately 3 months.
|
0.00%
0/12 • From the time of signing informed consent through study completion, approximately 3 months.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
8.3%
1/12 • Number of events 1 • From the time of signing informed consent through study completion, approximately 3 months.
|
0.00%
0/12 • From the time of signing informed consent through study completion, approximately 3 months.
|
Additional Information
Terry Noah, MD
University of North Carolina at Chapel Hill
Phone: 919-966-1055
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place