NCT02690064: CF-AOX

Mechanisms for Vascular Dysfunction and Exercise Tolerance in CF

Active, enrolled NA Last updated 27 January 2025

What this trial tests

NA trial testing Acute Antioxidant in Cystic Fibrosis in 13 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 April 2015

Primary endpoint
1 December 2026

1 January 2027

Quick facts

Lead sponsor	Augusta University
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	13
Start date	1 April 2015
Primary completion	1 December 2026
Estimated completion	1 January 2027
Sites	1 location across United States

Drugs / interventions tested

• Acute Antioxidant
• Chronic Antioxidant
• Placebo

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

Augusta University

Who can join

7 and older, any sex, with Cystic Fibrosis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Acute Change in Flow mediated dilation
  Time frame: Change from baseline (2 hours)
  Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
• Chronic Change in Flow mediated dilation
  Time frame: Baseline, week 4, week 8, and week 12
  Flow-Mediated Dilation will be determined at baseline, week 4, week 8 and week 12.
• Acute Change in exercise capacity (VO2 peak)
  Time frame: Baseline and 2 hours following acute antioxidant treatment
  Subjects will perform a baseline maximal exercise capacity test and on a separate visit perform a maximal exercise capacity test 2 hours following acute antioxidant treatment
• Chronic Change in exercise capacity (VO2 peak)
  Time frame: Baseline, week 4, week 8, and week 12
  Subjects will perform a maximal exercise capacity test at baseline, week 4, week 8, and week 12.

Sponsor's own description

Cystic fibrosis has many health consequences. A reduction in the ability to perform exercise in patients with CF is related to greater death rates, steeper decline in lung function, and more frequent lung infections. However, the physiological mechanisms for this reduced exercise capacity are unknown. The investigators recently published the first evidence of systemic vascular dysfunction in patients with CF. Therefore, it is reasonable to suspect that the blood vessels are involved with exercise intolerance in CF. This study will look at how and if oxidative stress contributes to both artery dysfunction and exercise intolerance in CF.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting oxidative stress in disease: promise and limitations of antioxidant therapy.
   Forman HJ, Zhang H. · · 2021 · cited 1789× · PMID 34194012 · DOI 10.1038/s41573-021-00233-1
2. Early aging and premature vascular aging in chronic kidney disease.
   Tanriover C, Copur S, Mutlu A, Peltek IB, et al · · 2023 · cited 34× · PMID 37915901 · DOI 10.1093/ckj/sfad076
3. Mitochondria-Targeted Antioxidants as a Therapeutic Strategy for Chronic Obstructive Pulmonary Disease.
   Fairley LH, Das S, Dharwal V, Amorim N, et al · · 2023 · cited 29× · PMID 37107348 · DOI 10.3390/antiox12040973
4. Multifaceted functions of Drp1 in hypoxia/ischemia-induced mitochondrial quality imbalance: from regulatory mechanism to targeted therapeutic strategy.
   Hao S, Huang H, Ma RY, Zeng X, et al · · 2023 · cited 28× · PMID 37833768 · DOI 10.1186/s40779-023-00482-8
5. The Therapeutic Strategies Targeting Mitochondrial Metabolism in Cardiovascular Disease.
   Huang X, Zeng Z, Li S, Xie Y, et al · · 2022 · cited 14× · PMID 36559254 · DOI 10.3390/pharmaceutics14122760
6. Mitochondrial Integrity Is Critical in Right Heart Failure Development.
   Müller M, Donhauser E, Maske T, Bischof C, et al · · 2023 · cited 8× · PMID 37446287 · DOI 10.3390/ijms241311108
7. Muscle oxygen utilization and ventilatory parameters during exercise in people with cystic fibrosis: Role of HbA_1c.
   Quertermous BP, Seigler N, Looney J, Crandall R, et al · · 2023 · cited 1× · PMID 37166356 · DOI 10.1177/14799731231174542