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

• Status: Terminated
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Treatments: Vardenafil Dihydrochloride

Criteria

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