A Phase 2 interventional study of Vardenafil and Placebo in Cystic Fibrosis, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Terminated at 1 site in Belgium. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2019-02-25.
Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Phase 2, Interventional, and Treatment
The purpose of this study is to investigate the effect of a nasal instillation of Vardenafil on nasal potential difference in cystic fibrosis patients homozygous for the F508del mutation
CFTR protein has been shown to be an ohmic, small conductance channel regulated by cAMP intracellular levels that are balanced by degradation through cyclic nucleotide phosphodiesterases (PDE). Several families of PDEs with varying selectivities for cAMP and/or cGMP have been identified.PDE5 is highly specific for cGMP and is involved in the regulation of the intracellular concentration of cGMP in various tissues. Recently, it has been shown, in a preclinical model of transgenic mice, that pharmacological doses of sildenafil and vardenafil, two clinically approved PDE5 inhibitors, stimulate chloride transport activity of the mutant F508del-protein (Lubamba et al, 2008); this parameter has been assessed by means of the nasal potential difference (NPD). An increasing effect of sildenafil on the expression of F508del-CFTR protein (Dormer et al,2005) was originally reported in nasal epithelial cells harvested from patients with cystic fibrosis and cultured on impermeable supports, a configuration that allows interaction of drugs with the apical side of epithelia.
This study aims at investigating the effect of a single local administration of vardenafil on NPD measurements in CF patients homozygous for the F508del mutation.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 5 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
visit 1
nasal instillation of Vardenafil ( visit 2 or 3)
Drug: Vardenafil
Nasal instillation of placebo (visit 3 or 2)
Drug: Placebo
Nasal instillation of Vardenafil
Nasal instillation of placebo matching in appearance with the Vardenafil instillation
Cumulated changes in response to Chloride-free solution and isoproterenol (reflecting chloride transport)
Time frame: Change from baseline (visit 1) and placebo to Vardenafil instillation
Change in basal voltage value and in amiloride response (reflecting sodium transport)
Time frame: Change from baseline (visit1) and placebo to Vardenafil instillation
This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain