Sildenafil for Cystic Fibrosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cystic FibrosisSildenafil 40mg oral capsule - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial found that sildenafil may help people with CF who have exercise intolerance by improving blood flow.

Eligible Conditions
  • Cystic Fibrosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Change in FMD between weeks 1 and 12

Week 1
Flow-Mediated Dilation (FMD)
Week 1
Cardiac strain
Week 12
6 Minute Walk Distance (6MWD)
Week 1
Skeletal muscle function
Week 1
CFQ-R respiratory domain score

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Sildenafil
1 of 2
Placebo Arm
1 of 2

Active Control

Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: Sildenafil · Has Placebo Group · Phase 2 & 3

Placebo Arm
Drug
PlaceboComparator Group · 1 Intervention: Placebo Oral capsule · Intervention Types: Drug
Sildenafil
Drug
ActiveComparator Group · 1 Intervention: Sildenafil 40mg oral capsule · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change in fmd between weeks 1 and 12

Who is running the clinical trial?

Augusta UniversityOTHER
193 Previous Clinical Trials
74,091 Total Patients Enrolled
4 Trials studying Cystic Fibrosis
116 Patients Enrolled for Cystic Fibrosis
Cystic Fibrosis FoundationOTHER
174 Previous Clinical Trials
34,800 Total Patients Enrolled
169 Trials studying Cystic Fibrosis
31,963 Patients Enrolled for Cystic Fibrosis
National Jewish HealthLead Sponsor
135 Previous Clinical Trials
318,274 Total Patients Enrolled
21 Trials studying Cystic Fibrosis
1,581 Patients Enrolled for Cystic Fibrosis
Jennifer Taylor-Cousar, MD, MSCSPrincipal Investigator - National Jewish Health
Duke University School Of Medicine (Medical School)
1 Previous Clinical Trials
5 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
5 Patients Enrolled for Cystic Fibrosis

Eligibility Criteria

Age Any Age · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
who weigh ≥ 40 kg: Patients aged 9 years or older who weigh at least 40 kilograms can receive the vaccine.
The forced expiratory volume at one second score for a patient must be greater than or equal to 30% of the predicted score and less than or equal to 70% for patients aged 18 or older
The person has a confirmed diagnosis of cystic fibrosis if their sweat chloride concentration is ≥60 milliequivalents/liter and/or they have a genotype with two identifiable disease-causing mutations consistent with CF, and they have one or more clinical features consistent with the CF phenotype.
Some people with CF are willing to maintain a chronic CF medication schedule
had a significantly greater BMI than those without diabetes
and without significant effort Ability to produce reproducible results from spirometry tests, and without much effort.
The person is clinically stable and does not have any signs of a respiratory infection
The patient's oxygen saturation is above 85% when they are resting and using room air.

Who else is applying?

How old are they?
< 18100.0%
What site did they apply to?
Augusta University100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%