CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Sildenafil (Acute-1 hour) +2 moredrug
Likely dose
Sildenafil (Acute-1 hour) 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02057458
NCT02057458Phase 2Completed

Role of Blood Flow and Vascular Function on Exercise Capacity in Cystic Fibrosis

Augusta University·interventional·Posted Feb 7, 2014·Updated Apr 24, 2020

In Brief

A Phase 2 clinical trial evaluating Sildenafil (Acute-1 hour), Sildenafil (Subchronic-4 weeks), and 1 other intervention for Cystic Fibrosis. Completed, enrolled 19 participants across 1 site.

Detailed Summary

Cystic fibrosis (CF) 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 laboratory 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 1) blood flow and 2) artery function contribute to exercise capacity in CF.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 7, 2014
Enrollment StartApr 1, 2014
Primary CompletionJul 1, 2018
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 12.4 years ago

Interventions

Sildenafil (Acute-1 hour)drug

Vascular function will be assessed 1 hour following oral ingestion of sildenafil (50 mg)

Sildenafil (Subchronic-4 weeks)drug

Vascular function will be assessed 4 weeks following 20 mg three times per day (TID) of sildenafil for four weeks

Placebodrug

Sugar pill designed to mimic the sildenafil treatment