| Sponsored by: | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
|---|---|
| Information provided by: | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
| ClinicalTrials.gov Identifier: | NCT01002534 |
Purpose 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
| Condition | Intervention | Phase |
|---|---|---|
| Cystic Fibrosis | Drug: Vardenafil Drug: Placebo | Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
| Official Title: | Does a Nasal Instillation of Vardenafil Normalize the Nasal Potential Difference in Cystic Fibrosis Patients Homozygous for the F508del Mutation? A Randomized, Double Blind, Placebo-controlled Study. |
- 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 ] [ Designated as safety issue: No ]
- Change in basal voltage value and in amiloride response (reflecting sodium transport) [ Time Frame: Change from baseline (visit1) and placebo to Vardenafil instillation ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| baseline: No Intervention visit 1 | |
| Vardenafil: Active Comparator nasal instillation of Vardenafil ( visit 2 or 3) | Drug: Vardenafil Nasal instillation of Vardenafil |
| Placebo: Placebo Comparator Nasal instillation of placebo (visit 3 or 2) | Drug: Placebo Nasal instillation of placebo matching in appearance with the Vardenafil instillation |
Detailed Description:
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 od 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 to investigate the effect of a single local administration of vardenafil on NPD measurements in CF patients homozygous for the F508del mutation.
Eligibility| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Cystic fibrosis patients homozygous for the F508del mutation as confirmed by a genetic test
- Aged 14 years and older
- Male and female
- FEV1 >50% of predicted normal
Exclusion Criteria:
- Acute respiratory tract infection or pulmonary exacerbation requiring antibiotic intervention within 2 weeks of visit 1
- Any condition prohibiting the correct measurement of the NPD
- Active or passive smoking
- Planned treatment or treatment with another investigational drug or therapy within 1 month prior to randomisation
Contacts and Locations| Contact: Patrick LEBECQUE, MD, PhD | +32 2 764 1111 ext 1939 | patrick.lebecque@uclouvain.be |
| Contact: Teresinha LEAL, MD, PhD | +32 2 764 6724 | teresinha.leal@uclouvain.be |
| Belgium | |
| Cliniques universitaires St. Luc | |
| Brussels, Belgium, 1200 | |
| Principal Investigator: | Patrick LEBECQUE, MD, PhD | Cliniques universitaires St.Luc (Université catholique de Louvain) |
| Principal Investigator: | Teresinha LEAL, MD, PhD | Cliniques universitaires St.Luc ( Université Catholique de Louvain) |
More Information Publications:
| Responsible Party: | Cliniques universitaires Saint-Luc (Université Catholique de Louvain) ( Patrick Lebecque, MD, PhD ) |
| Study ID Numbers: | VARD-99 |
| Study First Received: | October 26, 2009 |
| Last Updated: | October 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT01002534 History of Changes |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
| Cystic Fibrosis Vardenafil Nasal instillation Nasal Potential difference |
Additional relevant MeSH terms:
| Cystic Fibrosis Fibrosis Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions Digestive System Diseases Pathologic Processes | Vardenafil Phosphodiesterase Inhibitors Respiratory Tract Diseases Genetic Diseases, Inborn Lung Diseases Pancreatic Diseases Infant, Newborn, Diseases |
ClinicalTrials.gov processed this record on October 27, 2009
http://www.clinicaltrials.gov/ct2/show/NCT01002534?term=cystic+fibrosis&recr=Open&rcv_d=14
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