Status:
COMPLETED
Does a Nasal Instillation of Miglustat 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 within a short delay the effect of nasal instillation of Miglustat on nasal potential difference in cystic fibrosis patients homozygous for the F508del muta...
Detailed Description
Miglustat is an inhibitor of α-glucosidases and other enzymes. Oral miglustat is currently marketed in Europa and US for the treatment of Gaucher type 1 patients for whom enzyme replacement treatment ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00945347
Start Date
July 1 2009
End Date
June 1 2011
Last Update
August 10 2011
Active Locations (1)
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1
Cliniques Universitaires St Luc (Université Catholique de Louvain) 10 avenue Hippocrate
Brussels, Belgium, 1200