Phase 2
N=16
Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00934362 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcome: Primary: Change in Mucociliary Clearance — 7.4; 9.5 percent clearance
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lucinactant first (Drug); Placebo first (Drug)
- Age
- Pediatric, Adult, Older Adult · 14+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mucociliary Clearance |
7.4; 9.5 | — |
| SECONDARY Spirometry |
.81; .23 | — |
Summary
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00934362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.