Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease

Phase 2

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: Placebo first; Drug: Lucinactant first

• Registration Number: NCT00934362
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

Detailed Description

This single-center pilot study is designed as a double-blind, randomized, cross-over clinical trial to evaluate the effects of inhaled lucinactant, an investigational peptide-containing synthetic surfactant (6 ml of 20 mg total phospholipid (TPL)/mL solution x 5 doses) in patients with mild to moderate CF lung disease. Lucinactant and vehicle will be delivered via a 510k approved vibrating mesh nebulizer, the Pari eFlowTM. The study duration corresponds to a 2-10 day screening phase, followed by a 20 day post-randomization phase that consists of two treatment periods (3 days each) and a washout period (14 days). A total of 16 patients will be enrolled and randomly assigned to one of two treatment sequences (Lucinactant followed by vehicle or vehicle followed by lucinactant). The primary outcome will be the rate of MC, as assessed via gamma scintigraphy, post-lucinactant and post vehicle. Secondary outcomes will include the rate of cough clearance (CC), lung clearance index (LCI), absolute change from baseline in FEV1 after 5 doses of study medication, CF-specific quality of life score (via CFQ-R instrument), in vitro assessments of sputum rheology, and various safety parameters.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-07-06
• Study First Submitted QC: 2009-07-07
• Study First Posted: 2009-07-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Results First Submitted: 2012-06-11
• Status Verified: 2013-01
• Results First Submitted QC: 2013-01-17
• Results First Posted: 2013-02-20
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Cystic fibrosis
• FEV1>40%

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo treatment first, then lucinactant treatment	Placebo first	0.9% NaCl vehicle treatment first, then washout period, then lucinactant treatment
Lucinactant first, then placebo	Lucinactant first	Active treatment first, then washout period, then placebo treatment

Primary Outcome Measures

Name	Time	Method
Change in Mucociliary Clearance	1 hour after final treatment (5th dose) minus baseline	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.

Secondary Outcome Measures

Name	Time	Method
Spirometry	after 5 doses	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.

Trial Locations

Locations (1)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States