Does a Nasal Instillation of Vardenafil Normalize the Nasal Potential Difference in Cystic Fibrosis Patients?

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2018-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Does a Nasal Instillation of Miglustat Normalize the Nasal Potential Difference in Cystic Fibrosis Patients ?

NCT00945347

Cystic Fibrosis

COMPLETED PHASE2

Effect of Miglustat on the Nasal Potential Difference in Patients With Cystic Fibrosis Homozygous for the F508del Mutation

NCT02325362

Cystic Fibrosis

COMPLETED PHASE2/PHASE3

Study of VX-809 in Cystic Fibrosis Subjects With the ∆F508-CFTR Gene Mutation

NCT00865904

Cystic Fibrosis

COMPLETED PHASE2

Miglustat in Cystic Fibrosis

NCT00742092

Cystic Fibrosis

COMPLETED PHASE2

Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion

NCT02070744

Cystic Fibrosis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

baseline

visit 1

Group Type NO_INTERVENTION

No interventions assigned to this group

Vardenafil

nasal instillation of Vardenafil ( visit 2 or 3)

Group Type ACTIVE_COMPARATOR

Vardenafil

Intervention Type DRUG

Nasal instillation of Vardenafil

Placebo

Nasal instillation of placebo (visit 3 or 2)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Nasal instillation of placebo matching in appearance with the Vardenafil instillation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vardenafil

Nasal instillation of Vardenafil

Intervention Type DRUG

Placebo

Nasal instillation of placebo matching in appearance with the Vardenafil instillation

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No