N/A
N=17
The Effect of N-Acetyl-L-Cysteine, on Inflammatory and Oxidative Stress Markers in Pulmonary Sarcoidosis
Pulmonary Sarcoidosis
Bottom Line
View on ClinicalTrials.gov: NCT01587001 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-α Levels — 40767; 39938; 45176; 25671 pg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- N-acetyl-cysteine (Dietary_supplement); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Jewish Health
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bronchoalveolar Lavage (BAL) and Peripheral Blood Mononuclear Cells (PBMC) TNF-α Levels |
40767; 39938; 45176; 25671; 2775; 637 | — |
| SECONDARY Bronchoalveolar Lavage (BAL) Cell Glutathione (GSH) Levels |
5.93; 9.39; 9.42; 4.28 | — |
Summary
This is a pilot study investigating the effect of an antioxidant, N-Acetyl-L-Cysteine (NAC), on inflammation and oxidative stress in sarcoidosis.
Eligibility Criteria
Inclusion Criteria
- Biopsy proven sarcoidosis.
- Pulmonary parenchymal involvement with a Scadding chest x-ray stage II, III or IV.
- Abnormal spirometry and/or DLCO (< 80% of predicted).
- Consenting adults : Age 18 years and above
Exclusion Criteria
- Positive lung washing or biopsy cultures for fungi or mycobacterial disease;
- Presence of other co-morbid conditions that may affect the patient's outcome.
- Patient inability to undergo venipuncture and BAL procedures.
- Current use of tobacco (smoking or otherwise) in the past 6 months
- Treatment with immunosuppressive therapy within the past 6 months.
- On oral anti-oxidant supplements.
- Active peptic ulcer disease.
Data sourced from ClinicalTrials.gov (NCT01587001). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.