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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate within a short delay the effect of nasal instillation of Miglustat 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: 1-Deoxynojirimycin; Miglustat

Criteria

Inclusion Criteria:

• Cystic fibrosis patients homozygous for the F508del mutation as confirmed by genetic test

• Aged 14 years and older

• Male or female (non-pregnant women who are to remain non-pregnant for 3 months after the end of the study)

• 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 such as respiratory tract infection

• Active or passive smoking

• Allergic chronic rhinitis

• History of significant lactose intolerance

• History of neuropathy

• History of cataracts or known increased risk of cataract formation

• Hypersensitivity to miglustat or any excipients

• Planned treatment or treatment with another investigational drug or therapy within 1 month prior to randomisation