Trial Outcomes & Findings for The Effect of N-Acetyl-L-Cysteine, on Inflammatory and Oxidative Stress Markers in Pulmonary Sarcoidosis (NCT NCT01587001)
NCT ID: NCT01587001
Last Updated: 2020-11-04
Results Overview
Baseline peripheral blood mononuclear cells and bronchoalveolar lavage (BAL) lymphocyte percentages and lipopolysaccharide (LPS) stimulated tumor necrosis factor-α levels (pg/ml)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
17 participants
Primary outcome timeframe
8 weeks of anti-oxidant therapy
Results posted on
2020-11-04
Participant Flow
Participant milestones
| Measure |
Oral N-acetyl-cysteine
N-acetyl-cysteine: 900mg three times daily for 8 weeks
|
Matching Placebo
Placebo: Matching placebo three times daily for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
3
|
|
Overall Study
COMPLETED
|
8
|
2
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
| Measure |
Oral N-acetyl-cysteine
N-acetyl-cysteine: 900mg three times daily for 8 weeks
|
Matching Placebo
Placebo: Matching placebo three times daily for 8 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Insufficient samples to complete testing
|
4
|
1
|
Baseline Characteristics
The Effect of N-Acetyl-L-Cysteine, on Inflammatory and Oxidative Stress Markers in Pulmonary Sarcoidosis
Baseline characteristics by cohort
| Measure |
Oral N-acetyl-cysteine
n=11 Participants
oral NAC 900mg three times daily for 8 weeks
N-acetyl-cysteine: 900mg three times daily for 8 weeks
|
Matching Placebo
n=3 Participants
Placebo: Matching placebo three times daily for 8 weeks.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 9 • n=5 Participants
|
52 years
STANDARD_DEVIATION 13 • n=7 Participants
|
53 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
3 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks of anti-oxidant therapyBaseline peripheral blood mononuclear cells and bronchoalveolar lavage (BAL) lymphocyte percentages and lipopolysaccharide (LPS) stimulated tumor necrosis factor-α levels (pg/ml)
Outcome measures
| Measure |
Oral N-acetyl-cysteine
n=8 Participants
N-acetyl-cysteine: 900mg three times daily for 8 weeks
|
Matching Placebo
n=2 Participants
Placebo: Matching placebo three times daily for 8 weeks.
|
|---|---|---|
|
Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-α Levels
Mean baseline BAL cell TNF-a
|
40767 pg/ml
Standard Deviation 25684
|
39938 pg/ml
Standard Deviation 12033
|
|
Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-α Levels
Mean follow-up BAL cell TNF-a
|
45176 pg/ml
Standard Deviation 17910
|
25671 pg/ml
Standard Deviation 12203
|
|
Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-α Levels
Mean baseline PBMC cell TNF-a
|
2775 pg/ml
Standard Deviation 2292
|
637 pg/ml
Standard Deviation 404
|
|
Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-α Levels
Mean follow-up PBMC cell TNF-a
|
3387 pg/ml
Standard Deviation 2481
|
969 pg/ml
Standard Deviation 135
|
SECONDARY outcome
Timeframe: 8 weeks of anti-oxidant therapyWe measured changes at baseline and at 8 weeks in BAL whole cell total GSH levels and cellular 8-OHdG before and after treatment with NAC/placebo.
Outcome measures
| Measure |
Oral N-acetyl-cysteine
n=8 Participants
N-acetyl-cysteine: 900mg three times daily for 8 weeks
|
Matching Placebo
n=2 Participants
Placebo: Matching placebo three times daily for 8 weeks.
|
|---|---|---|
|
Bronchoalveolar Lavage (BAL) Cell Glutathione (GSH) Levels
Baseline visit
|
5.93 nmol/mg protein
Standard Deviation 2.94
|
9.39 nmol/mg protein
Standard Deviation 2.06
|
|
Bronchoalveolar Lavage (BAL) Cell Glutathione (GSH) Levels
8 week visit
|
9.42 nmol/mg protein
Standard Deviation 3.64
|
4.28 nmol/mg protein
Standard Deviation 0.12
|
Adverse Events
Oral N-acetyl-cysteine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place