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Phase 2 N=15 Randomized Treatment

Long Term Nitric Oxide Bioavailability on Vascular Health in Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD)

Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Change in Flow Mediated Dilation — 0.26; -1.5 percentage of flow mediated dilation

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Tetrahydrobiopterin (BH4) (Drug); Antioxidant Cocktail (Dietary_supplement)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Augusta University
Primary completion
Jul 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Flow Mediated Dilation
0.26; -1.5
SECONDARY
Change in PWV (Pulse Wave Velocity)
-0.36; 0.34
SECONDARY
FEV1 %Predicted
-3.6; -4.2
SECONDARY
Percent of ACH to Heat Max
4.2; -0.8

Summary

Chronic obstructive pulmonary disease (COPD) affects up to 14 million people and is among the top five leading causes of death worldwide. Although COPD is a disease of the lungs, recent evidence indicates that COPD is associated with multiple systemic consequences including vascular endothelial dysfunction. Recently, it has been suggested that more patients with COPD die from cardiovascular disease and coronary heart disease than of direct pulmonary complications. Examination of the mechanisms that contribute to a reduction nitric oxide (NO) bioavailability resulting in vascular endothelial dysfunction in patients with COPD are important as endothelial dysfunction has been indicated to be an independent predictor of future atherosclerotic cardiovascular disease and events.

Eligibility Criteria

Inclusion Criteria

  • patients with medically diagnosed COPD
  • apparently healthy controls

Exclusion Criteria

  • FEV1/FVC >0.7 (normal lung function in patients only)
  • Clinical diagnosis of heart disease or diabetes
  • Vasoactive medications (i.e. nitrates, beta-blockers, Viagra etc.)
  • uncontrolled high blood pressure
  • high blood pressure in your lungs
  • thyroid problems
  • Fluid in the lungs
  • Sleep apnea
  • Anemia
  • Raynaud's Phenomenon
  • GI bleeding
  • Gangrene of the digits
  • History of low platelets or coagulopathies
  • Phenylketonuria (PKU)
  • Any allergy to Kuvan
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02774226). 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.

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