Trial Outcomes & Findings for Oxidative Stress in Asthma (NCT NCT04512547)
NCT ID: NCT04512547
Last Updated: 2026-03-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
Up to 6 weeks
Results posted on
2026-03-23
Participant Flow
Participant milestones
| Measure |
Obese Asthmatics
Obese patients that come to Duke that have been diagnosed with Asthma will be approached.
|
Obese Non-Asthmatics
The obese non-asthmatics will be collected from an IRB pre-approved Healthy Volunteer Data Repository.
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
8
|
|
Overall Study
COMPLETED
|
26
|
8
|
|
Overall Study
NOT COMPLETED
|
15
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxidative Stress in Asthma
Baseline characteristics by cohort
| Measure |
Obese Asthmatics
n=26 Participants
Obese patients that come to Duke that have been diagnosed with Asthma will be approached.
|
Obese Non-Asthmatics
n=8 Participants
The obese non-asthmatics will be collected from an IRB pre-approved Healthy Volunteer Data Repository.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.3 years
STANDARD_DEVIATION 8.5 • n=10 Participants
|
46.6 years
STANDARD_DEVIATION 11.0 • n=8 Participants
|
47.1 years
STANDARD_DEVIATION 9.0 • n=18 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=10 Participants
|
6 Participants
n=8 Participants
|
27 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=10 Participants
|
2 Participants
n=8 Participants
|
7 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=10 Participants
|
8 Participants
n=8 Participants
|
34 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=10 Participants
|
3 Participants
n=8 Participants
|
12 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=10 Participants
|
5 Participants
n=8 Participants
|
21 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=10 Participants
|
8 Participants
n=8 Participants
|
34 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: Up to 6 weeksOutcome measures
| Measure |
Obese Asthmatics
n=26 Participants
Obese patients that come to Duke that have been diagnosed with Asthma will be approached.
|
Obese Non-Asthmatics
n=8 Participants
The obese non-asthmatics will be collected from an IRB pre-approved Healthy Volunteer Data Repository.
|
|---|---|---|
|
Percentage of Neutrophils in Peripheral Blood
|
57.3 percentage of neutrophils
Standard Deviation 7.4
|
55.4 percentage of neutrophils
Standard Deviation 10.2
|
PRIMARY outcome
Timeframe: Up to 6 weeksOutcome measures
| Measure |
Obese Asthmatics
n=26 Participants
Obese patients that come to Duke that have been diagnosed with Asthma will be approached.
|
Obese Non-Asthmatics
n=8 Participants
The obese non-asthmatics will be collected from an IRB pre-approved Healthy Volunteer Data Repository.
|
|---|---|---|
|
Percentage of Eosinophils in Peripheral Blood
|
2.6 percentage of eosinophils
Standard Deviation 1.4
|
2.8 percentage of eosinophils
Standard Deviation 1.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 6 weeksMeasured by staining of fixed and reversible airway biopsy tissue with Masson's trichrome stain or Weigert's resorcin-fuchsin stain and quantification of staining in submucosal regions using Image J
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, visit 1 (one week +/- 7 day), visit 2 (one week +/- 7 day), visit 3 (one week +/- 7 day)Measured by Flow cytometry
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 6 weeksMeasured by Matrigel invasion assay with manual counting of stained invading fibroblasts
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, visit 1 (one week +/- 7 day), visit 2 (one week +/- 7 day), visit 3 (one week +/- 7 day)Measured by Amplex Red assay
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, visit 1 (one week +/- 7 day), visit 2 (one week +/- 7 day), visit 3 (one week +/- 7 day)Measured by Enzyme-linked Immunosorbant Assay
Outcome measures
Outcome data not reported
Adverse Events
Obese Asthmatics
Serious events: 0 serious events
Other events: 6 other events
Deaths: 6 deaths
Obese Non-Asthmatics
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Obese Asthmatics
n=26 participants at risk
Obese patients that come to Duke that have been diagnosed with Asthma will be approached.
|
Obese Non-Asthmatics
n=8 participants at risk
The obese non-asthmatics will be collected from an IRB pre-approved Healthy Volunteer Data Repository.
|
|---|---|---|
|
Eye disorders
Eye redness
|
3.8%
1/26 • Up to 6 weeks
|
0.00%
0/8 • Up to 6 weeks
|
|
Eye disorders
Broken blood vessel
|
3.8%
1/26 • Up to 6 weeks
|
0.00%
0/8 • Up to 6 weeks
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
1/26 • Up to 6 weeks
|
0.00%
0/8 • Up to 6 weeks
|
|
Nervous system disorders
Syncope
|
3.8%
1/26 • Up to 6 weeks
|
0.00%
0/8 • Up to 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Blood in sputum
|
11.5%
3/26 • Up to 6 weeks
|
0.00%
0/8 • Up to 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
4/26 • Up to 6 weeks
|
12.5%
1/8 • Up to 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.8%
1/26 • Up to 6 weeks
|
12.5%
1/8 • Up to 6 weeks
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Up to 6 weeks
|
0.00%
0/8 • Up to 6 weeks
|
|
Nervous system disorders
Headache
|
3.8%
1/26 • Up to 6 weeks
|
0.00%
0/8 • Up to 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
3.8%
1/26 • Up to 6 weeks
|
0.00%
0/8 • Up to 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
7.7%
2/26 • Up to 6 weeks
|
0.00%
0/8 • Up to 6 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wet feeling in lungs
|
0.00%
0/26 • Up to 6 weeks
|
12.5%
1/8 • Up to 6 weeks
|
|
Surgical and medical procedures
Equipment malfunction
|
0.00%
0/26 • Up to 6 weeks
|
12.5%
1/8 • Up to 6 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place