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Phase 2 Completed N=16 Randomized Quadruple-blind Treatment

Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease

Source: ClinicalTrials.gov NCT00934362 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcomePrimary: Change in Mucociliary Clearance — 7.4; 9.5 percent clearance

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Mucociliary Clearance
7.4; 9.5
SECONDARY
Spirometry
.81; .23

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)
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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