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NCT01772758 · ClinicalTrials.gov registry record · Phase 2
Cystic Fibrosis and Endothelial Function: At Rest and During Exercise
A Phase 2 study, sponsored by Augusta University.
- Completed
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT01772758: Completed Phase 2 study, sponsored by Augusta University.
NCT01772758 is a Phase 2 study that has completed, run by Augusta University. The registered enrollment target is 64 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01772758, a Phase 2 study, has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study Summary
Perhaps one of the most disturbing aspects of Cystic Fibrosis (CF) is the associated premature death. Oxidative stress has been observed in patients with CF and exercise intolerance has been shown to predict mortality in patients with CF, regardless of how healthy their lungs are. A critical barrier to improving the quality of life and longevity in patients with CF is our lack of knowledge regarding the different reasons why patients with CF cannot exercise to the level of their peers. We have collected preliminary data to support our central hypothesis that oxidative stress contributes to the impairment in blood vessel function at rest and during exercise which ultimately oxygen transport and delivery resulting in exercise intolerance. Exercise is therapeutic medicine for patients with CF and this investigation represents a major breakthrough in the approach to begin understanding the physiological mechanisms which contribute to exercise intolerance in these patients.
Primary Outcome
Brachial artery FMD induced by reactive hyperemia assessed vascular endothelial function at baseline and several hours after treatment.
Interventions
- DIETARY_SUPPLEMENT Antioxidant Cocktail
- DRUG BH4 5mg
- DRUG BH4 20mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2011-08 |
| Est. Completion | 2016-06-21 |
| Phase | Phase 2 |
What the finished NCT01772758 record still lists
NCT01772758 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 3 interventions - of which Antioxidant Cocktail is the first listed.
NCT01772758 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01772758 about?
NCT01772758 is a clinical study titled "Cystic Fibrosis and Endothelial Function: At Rest and During Exercise". Perhaps one of the most disturbing aspects of Cystic Fibrosis (CF) is the associated premature death. Oxidative stress has been observed in patients with CF and exercise intolerance has been shown to predict mortality in patients with CF, regardless of how healthy their lungs are. A critical barrier...
What is the current status of trial NCT01772758?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2011-08. Estimated completion is 2016-06-21.
What interventions are being tested in trial NCT01772758?
The interventions under investigation include: Antioxidant Cocktail (DIETARY_SUPPLEMENT), BH4 5mg (DRUG), BH4 20mg (DRUG).
Who is sponsoring clinical trial NCT01772758?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01772758's enrollment target sits among peer trials
64 996th of 2000 higher than 992 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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