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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02057458
Date of registration: 04/02/2014
Prospective Registration: Yes
Primary sponsor: Augusta University
Public title: Blood Flow and Vascular Function in Cystic Fibrosis CF-FLOW
Scientific title: Role of Blood Flow and Vascular Function on Exercise Capacity in Cystic Fibrosis
Date of first enrolment: April 2014
Target sample size: 19
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02057458
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     Ryan Harris, Ph.D.
Address: 
Telephone:
Email:
Affiliation:  Augusta University
Key inclusion & exclusion criteria

Inclusion Criteria.

- Diagnosis of CF and healthy controls

- Men and women (greater than 18 yrs. old)

- Resting oxygen saturation (room air) greater than 90%

- Forced expiratory volume (FEV1) percent predicted greater than 30%

- Patients with or without CF related diabetes

- Traditional CF-treatment medications

- Ability to perform reliable/reproducible pulmonary function tests (PFT)

- Clinically stable for 2 weeks (no exacerbations or need for antibiotic treatment
within 2 weeks of testing or major change in medical status)

Exclusion Criteria.

- Children less than 17 years old

- Body mass less than 20 kg

- A diagnosis of pulmonary arterial hypertension (PAH)

- FEV1 less than 30% of predicted

- Resting oxygen saturation (SpO2) less than 90%

- Self-reported to be a smoker

- Current use of any vaso-active medications

- History of migraine headaches

- Pregnant or nursing at the time of the investigation

- A clinical diagnosis of cardiovascular disease, hypertension, or CF related diabetes



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Cystic Fibrosis
Intervention(s)
Drug: Placebo
Drug: Sildenafil (Acute-1 hour)
Drug: Sildenafil (Subchronic-4 weeks)
Primary Outcome(s)
Absolute Change in Diameter [Time Frame: pre-treatment Baseline and following 4 weeks sub-chronic treatment]
Acute Study: Percentage Flow-Mediated Dilation (FMD) [Time Frame: pre-treatment Baseline and 1 hour post-treatment]
Baseline Diameter [Time Frame: pre-treatment Baseline and following 4 weeks sub-chronic treatment]
FEV1 (% Predicted) [Time Frame: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment]
Peak Diameter [Time Frame: pre-treatment Baseline and following 4 weeks sub-chronic treatment]
RER Peak [Time Frame: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment]
VE Peak [Time Frame: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment]
VO2 Peak (Absolute) [Time Frame: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment]
VO2 Peak (Percent Predicted) [Time Frame: pre-treatment Baseline and 1 hour post-treatment, and 4 weeks sub-chronic treatment]
VO2 Peak (Relative) [Time Frame: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment]
Secondary Outcome(s)
Secondary ID(s)
DK100783
R21DK100783
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Ethics review
Results
Results available: Yes
Date Posted: 24/04/2020
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02057458
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