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

NCT01002534 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-02-25

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

Vardenafil

Nasal instillation of Vardenafil

DRUG

Placebo

Nasal instillation of placebo matching in appearance with the Vardenafil instillation

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Principal Investigators

  • Patrick LEBECQUE, MD, PhD · Cliniques universitaires St.Luc (Université catholique de Louvain)

  • Teresinha LEAL, MD, PhD · Cliniques universitaires St.Luc ( Université Catholique de Louvain)

  • Anissa LEONARD, MD · Cliniques universitaires St.Luc (Université Catholique de Louvain)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-06-30
Completion
2018-03-31

Countries

  • Belgium

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01002534 on ClinicalTrials.gov