Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease

NCT00934362 | Completed Phase 2 Results DMC

• 3 other identifiers: 08-0795KL4-CF-01DONALD04A0
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Change in Mucociliary Clearance

  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.

  1 hour after final treatment (5th dose) minus baseline

Secondary Outcomes (1)

• Spirometry

  after 5 doses

Study Arms (2)

Lucinactant first, then placebo

OTHER

Active treatment first, then washout period, then placebo treatment

Drug: Lucinactant first

Placebo treatment first, then lucinactant treatment

OTHER

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

Drug: Placebo first

Interventions

Lucinactant first DRUG

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

Also known as: KL-4 surfactant, lucinactant, aerosurf

Lucinactant first, then placebo

Placebo first DRUG

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

Also known as: normal saline, 0.9% NaCl

Placebo treatment first, then lucinactant treatment

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cystic fibrosis
• FEV1\>40%

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Cystic Fibrosis Foundation: collaborator
• Windtree Therapeutics: collaborator

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

lucinactant; Saline Solution

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Scott Donaldson
• Organization: University of North Carolina at Chapel Hill

scott_donaldson@med.unc.edu

919-966-9198

Study Officials

• Scott H Donaldson, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 8, 2009
• Study Start: October 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: March 13, 2017
• Results First Posted: February 20, 2013

Record last verified: 2013-01

Locations

US (1)