Status:
TERMINATED
Does a Nasal Instillation of Vardenafil Normalize the Nasal Potential Difference in Cystic Fibrosis Patients?
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
14+ years
Phase:
PHASE2
Brief 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
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). Severa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01002534
Start Date
October 1 2011
End Date
March 1 2018
Last Update
February 25 2019
Active Locations (1)
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1
Cliniques universitaires St. Luc
Brussels, Belgium, 1200