Cystic Fibrosis Clinical Trial
Official title:
A Double Blind, Cross-Over Study Comparing Aerosolized Lucinactant and Vehicle on Mucociliary Clearance for Cystic Fibrosis Lung Disease
Mucus clearance is impaired in cystic fibrosis. Inhaled surfactants may reduce adhesive forces between mucus and airway surfaces and improve mucus clearance. This in turn my improve lung health. The investigators propose to measure mucus clearance before and after lucinactant or vehicle administration in patients with cystic fibrosis.
Status | Completed |
Enrollment | 16 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 14 Years and older |
Eligibility |
Inclusion Criteria: - Cystic fibrosis - FEV1>40% Exclusion Criteria: - Unstable lung disease - Unable or unwilling to stop hypertonic saline and dornase alfa for 3 days prior to each study period - Relevant drug allergy or intolerance - Recent investigational drug use (30 days) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Cystic Fibrosis Foundation Therapeutics, Discovery Laboratories, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Mucociliary Clearance | Clearance of radiolabeled particles, following inhalation, are followed over time. Average clearance rate through 60 minutes post inhaled isotope deposition is calculated. Absolute difference between baseline and post-treatment (e.g. <60 minutes after the last dose of lucinactant or placebo) reported. | 1 hour after final treatment (5th dose) minus baseline | No |
Secondary | Spirometry | Percent change (relative) in FEV1 between pre-treatment baseline and following 5 doses of study treatment. Post treatment values obtained 3 and approximately 22 hours after 5th dose were averaged to determine the treatment effect. | after 5 doses | Yes |
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