drugset / Trial / NCT04039087
Sildenafil Exercise: Role of PDE5 Inhibition
Phase 2/3
Completed
26 enrolled
National Jewish Health
Augusta University · collabCystic Fibrosis Foundation · collab
RandomizedParallel-groupQuadruple-blindSupportive care
Summary
Exercise intolerance is an understudied phenomenon in people with CF. The investigators hypothesized that vascular dysfunction plays a significant role, and can be partially reversed by administration of the phosphodiesterase type 5 (PDE5) inhibitor, sildenafil.
Timeline
- Start
- 2019-09-05
- Primary completion
- 2024-06-30
- Completion
- 2024-06-30
Publications
- Background Taylor-Cousar JL, Wiley C, Felton LA, St Clair C, Jones M, Curran-Everett D, Poch K, Nichols DP, Solomon GM, Saavedra MT, Accurso FJ, Nick JA. Pharmacokinetics and tolerability of oral sildenafil in adults with cystic fibrosis lung disease. J Cyst Fibros. 2015 Mar;14(2):228-36. doi: 10.1016/j.jcf.2014.10.006. Epub 2014 Nov 13.
- Background Rodriguez-Miguelez P, Lee N, Tucker MA, Csanyi G, McKie KT, Forseen C, Harris RA. Sildenafil improves vascular endothelial function in patients with cystic fibrosis. Am J Physiol Heart Circ Physiol. 2018 Nov 1;315(5):H1486-H1494. doi: 10.1152/ajpheart.00301.2018. Epub 2018 Aug 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Sildenafil | Unknown | 40 mg | Oral |