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NCT01132482 · ClinicalTrials.gov registry record · Phase 2
Effects of Sildenafil on CFTR-dependent Ion Transport Activity
A Phase 2 study of Cystic Fibrosis, sponsored by National Jewish Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT01132482: Completed Phase 2 study of Cystic Fibrosis, sponsored by National Jewish Health.
NCT01132482 is a Phase 2 study of Cystic Fibrosis that has completed, run by National Jewish Health. The registered enrollment target is 19 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01132482, a Phase 2 study of Cystic Fibrosis, has completed, sponsored by National Jewish Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
Dehydrated airway surfaces resulting from sodium hyperabsorption and lack of chloride secretion are critical to the pathology that leads to the morbidity and mortality from Cystic Fibrosis (CF) lung disease. Previously published work in CF cell lines has demonstrated that by increasing cGMP and restoring inhibition of ENaC, sodium hyperabsorption may be reversed following administration of a phosphodiesterase inhibitor (PDEi,) such as sildenafil. Additionally it has been shown in CF cell lines and animal models, that phosphodiesterase inhibitors/analogues can enhance chloride secretion and/or correct surface localization of ΔF508 CFTR. The goal of this project is to translate the results of this work from the laboratory into a clinical trial in patients with CF using an FDA-approved therapy. The Specific Aims of this project are to: 1) Evaluate the effect of systemically administered phosphodiesterase inhibitors on ion transport in CF by measurement of Na+ and Cl- conductance by NPD and Na+ and Cl- concentration in sweat utilizing pilocarpine iontophoresis 2) To establish appropriate dosing of sildenafil in CF by performing a dose-escalation study during which patients are carefully monitored for side effects, plasma sildenafil levels are obtained and outcome measures are compared based on the dose of sildenafil administered. The results of this study in conjunction with those from an ongoing study examining the role of sildenafil as an anti-inflammatory in CF will aid in establishing safety, pharmacokinetics and mechanism of action of sildenafil in the treatment of CF lung disease.
Primary Outcome
Amount of sodium transported across the nasal epithelium
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sildenafil
Study Locations (1)
Colorado
- National Jewish Health - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2015-10 |
| Est. Completion | 2017-05 |
| Phase | Phase 2 |
What the finished NCT01132482 record still lists
NCT01132482 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01132482 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT01132482 about?
NCT01132482 is a clinical study titled "Effects of Sildenafil on CFTR-dependent Ion Transport Activity". Dehydrated airway surfaces resulting from sodium hyperabsorption and lack of chloride secretion are critical to the pathology that leads to the morbidity and mortality from Cystic Fibrosis (CF) lung disease. Previously published work in CF cell lines has demonstrated that by increasing cGMP and rest...
What is the current status of trial NCT01132482?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2015-10. Estimated completion is 2017-05.
What conditions does trial NCT01132482 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT01132482?
The interventions under investigation include: Placebo (DRUG), Sildenafil (DRUG).
Who is sponsoring clinical trial NCT01132482?
This trial is sponsored by National Jewish Health, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01132482 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01132482's enrollment target sits among peer trials
19 133rd of 169 higher than 36 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis 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.
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