CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
Lucinactant first +1 moredrug
Likely dose
Lucinactant first 120 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00934362
NCT00934362Phase 2Completed

A Double Blind, Cross-Over Study Comparing Aerosolized Lucinactant and Vehicle on Mucociliary Clearance for Cystic Fibrosis Lung Disease

University of North Carolina, Chapel Hill·interventional·Posted Jul 8, 2009·Updated Mar 13, 2017

In Brief

A Phase 2 clinical trial evaluating Lucinactant first and Placebo first for Cystic Fibrosis. Completed, enrolled 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 8, 2009
Enrollment StartOct 1, 2008
Primary CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.0 years ago

Interventions

Lucinactant firstdrug

lucinactant 120 mg (20 mg/ml) x 5 doses over 24 hours, then washout period x 14 days, then vehicle x 5 doses over 24 hrs

Placebo firstdrug

6 mL normal saline x 5 doses over 24 hours, then washout period x 14 days, then lucinactant x 5 doses over 24 hours