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Phosphodiesterase type 5 (PDE5) inhibitor
Sildenafil for Exercise Intolerance in Cystic Fibrosis
Phase 2 & 3
Recruiting
Led By Jennifer Taylor-Cousar, MD, MSCS
Research Sponsored by National Jewish Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Willingness to maintain chronic CF medication schedule (e.g. alternating month inhaled antibiotics)
Confirmed diagnosis of cystic fibrosis (CF) based on positive sweat chloride concentration ≥60 milliequivalents (mEq)/liter (by pilocarpine iontophoresis) and/or genotype with two identifiable disease-causing mutations consistent with CF, and accompanied by one or more clinical features consistent with the CF phenotype
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in fmd between weeks 1 and 12
Awards & highlights
Study Summary
This trial found that sildenafil may help people with CF who have exercise intolerance by improving blood flow.
Who is the study for?
This trial is for people over 9 years old with cystic fibrosis who have a certain level of lung function and are stable without recent infections. They must be able to perform spirometry tests, maintain their CF medication schedule, and not be pregnant or breastfeeding. Excluded are those with severe diseases, anatomical deformities, drug sensitivities, or taking certain medications.Check my eligibility
What is being tested?
The study is testing whether sildenafil can improve exercise ability in individuals with cystic fibrosis by addressing vascular dysfunction. Participants will either receive the actual drug or a placebo capsule to compare outcomes.See study design
What are the potential side effects?
Sildenafil may cause headaches, flushing, indigestion, vision changes like increased sensitivity to light or blurred vision; rare side effects include priapism (prolonged erection) and potential heart issues in predisposed individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to follow a strict CF medication schedule.
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I have cystic fibrosis confirmed by a sweat test or genetic test.
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My lung function, measured by FEV1, is within the required range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in fmd between weeks 1 and 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in fmd between weeks 1 and 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6 Minute Walk Distance (6MWD)
Secondary outcome measures
CFQ-R respiratory domain score
Cardiac strain
Flow-Mediated Dilation (FMD)
+1 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: SildenafilActive Control1 Intervention
active sildenafil 40 mg p.o. three times per day
Group II: Placebo ArmPlacebo Group1 Intervention
placebo three times per day
Find a Location
Who is running the clinical trial?
Cystic Fibrosis FoundationOTHER
189 Previous Clinical Trials
37,170 Total Patients Enrolled
182 Trials studying Cystic Fibrosis
34,233 Patients Enrolled for Cystic Fibrosis
Augusta UniversityOTHER
211 Previous Clinical Trials
85,028 Total Patients Enrolled
4 Trials studying Cystic Fibrosis
116 Patients Enrolled for Cystic Fibrosis
National Jewish HealthLead Sponsor
140 Previous Clinical Trials
316,196 Total Patients Enrolled
23 Trials studying Cystic Fibrosis
1,691 Patients Enrolled for Cystic Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking strong CYP3A4 inhibitors like ketoconazole.I have had priapism or have known deformities of the penis.You have had a bad reaction to sildenafil in the past.I do not have a history of serious liver disease.I am currently using or have used nitrates, α-blockers, or Ca channel blockers within the last month.I am not pregnant, breastfeeding, and I agree to use birth control during the study.I have had serious eye diseases like retinal problems.I started CFTR modulator therapy less than a month ago.I have a severe blood disorder or a current INR greater than 2.0.You can breathe into a spirometer machine in a consistent and accurate way.I haven't had a lung infection or worsening of lung symptoms in the last 14 days.I have a history of serious heart disease.I am willing to follow a strict CF medication schedule.You had a positive test for certain bacteria in your sputum or throat swab within the past 2 years.You have severe pulmonary hypertension as detected by an echocardiogram showing high pressure in the arteries of the lungs.I have a history of migraine headaches.I weigh less than 20 kilograms.I am 8 years old or younger.I have had a severe neurological condition, like a stroke.I have cystic fibrosis confirmed by a sweat test or genetic test.I am currently taking blood thinners.My lung function, measured by FEV1, is within the required range.I have had severe kidney problems (creatinine >1.8 mg/dL).You may or may not have diabetes related to cystic fibrosis.I am 9 years old or older.I cannot swallow pills.I have had an organ transplant.Your oxygen level while resting is more than 85%.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Arm
- Group 2: Sildenafil
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people still being signed up for this research project?
"The clinical trial is currently looking for patients, as seen on the website clinicaltrials.gov. The posting went up on September 5th, 2019 and was edited August 29th of this year."
Answered by AI
How many people are enrolling in this clinical trial?
"That is correct, the online information from clinicaltrials.gov does state that this particular trial is recruiting at this time. This trial was originally posted on September 5th, 2019 and was updated as recently as August 29th, 2020. They are looking for a total of 40 participants between 2 locations."
Answered by AI
For what ailments is Sildenafil typically prescribed?
"Sildenafil is an approved medication for the treatment of premature ejaculation, nyha functional class ii-iii pulmonary arterial hypertension, and pulmonary arterial hypertension."
Answered by AI
Could you tell me if Sildenafil has been studied before?
"Originally, sildenafil was researched in 2013 at Virginia Commonwealth University/Massey Cancer Center. Consequently, there have been 185 completed studies thus far. Currently, 26 different trials are actively recruiting patients; a large portion of these taking place in Denver, Colorado."
Answered by AI
Who else is applying?
How old are they?
< 18
What site did they apply to?
Augusta University
What portion of applicants met pre-screening criteria?
Met criteria
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