N/A
N=60
Nitric Oxide Bioavailability in Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT01398943 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Flow-Mediated Dilation (FMD) — 3.1; 6.7; 4.7; 6.9 percentage of change in FMD — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tetrahydrobiopterin (BH4) (Drug); Antioxidant Cocktail (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Augusta University
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Flow-Mediated Dilation (FMD) |
3.1; 6.7; 4.7; 6.9 | <0.05 sig |
| SECONDARY Pulse Wave Velocity |
14; 11; 11; 10 | <0.05 sig |
Summary
More patients with chronic obstructive pulmonary disease (COPD) die from cardiovascular disease than direct pulmonary complications. Inflammation and oxidative stress, characteristic in COPD, are likely contributors to the reduction in nitric oxide (NO) bioavailability and vascular endothelial dysfunction in COPD patients; however, this has yet to be determined. Thus, the overall objective of this proposal is to identify the role of NO bioavailability in contributing to vascular endothelial dysfunction in patients with COPD and to provide insight into the molecular mechanisms involved. Our central hypothesis is that inflammation and oxidative stress, both independently, contribute to the reduction in NO bioavailability and vascular endothelial dysfunction in patients with COPD.
Eligibility Criteria
Inclusion Criteria
- Patients with COPD (GOLD stages II-IV) and matched healthy controls
- Caucasian or African American
- Both men and women
- Current and former smokers
Exclusion Criteria
- GOLD Stage I
- Clinical diagnosis of heart disease, hypertension, or metabolic disease
- Vasoactive medications (i.e. nitrates, beta-blockers, ACE inhibitors, Viagra, etc.)
- Pulmonary hypertension
- Hypothyroidism
- Hyper-homocysteinemia
- Interstitial lung disease
- Phenylketonuria
- Pregnancy
- Sleep apnea
- Anemia
- Raynod's phenomenon
- Gangrene of the digits
- History of low platelets or coagulopathies
- Aspirin sensitivity or allergy
Data sourced from ClinicalTrials.gov (NCT01398943). 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.