OBJECTIVES: Determine whether copies of the cystic fibrosis gene (pGT-1) can be delivered to the cells lining the nose of cystic fibrosis patients using cationic liposome (DMRIE/DOPE) mediated gene transfer.

Condition	Treatment or Intervention	Phase
Cystic Fibrosis	Gene Transfer: pGT-1 gene lipid complex	Phase I

Further Study Details: 

Expected Total Enrollment:  9

PROTOCOL OUTLINE: Under direct visualization, patients receive lipid/DNA formulation (pGT-1 lipid complex) by syringe instillation over 30 minutes to the right inferior nasal turbinate. Patients are followed daily for 7 days, twice a week for 3 weeks, every 2-3 weeks for 10 weeks, then every 3 months thereafter.

Ages Eligible for Study:  16 Years and above,  Genders Eligible for Study:  Both

Criteria

• Cystic fibrosis patients
• Not pregnant Fertile patients must use effective contraception

Study chairs or principal investigators

Eric J. Sorscher,  Study Chair,  University of Alabama   

Study ID Numbers:  199/13941; UAB-6097; UAB-F930923001
Record last reviewed:  June 2000
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004471
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08