Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease

University of North Carolina (UNC)

Status and phase: Completed; Phase 2

Conditions: Cystic Fibrosis

Treatments: Drug: Lucinactant first; Drug: Placebo first

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00934362

KL4-CF-01

08-0795

DONALD04A0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups

Lucinactant first, then placebo

Other group

Description:

Active treatment first, then washout period, then placebo treatment

Treatment:

Drug: Lucinactant first

Placebo treatment first, then lucinactant treatment

Other group

Description:

0.9% NaCl vehicle treatment first, then washout period, then lucinactant treatment

Treatment:

Drug: Placebo first