Inhaled surfactants may improve mucus clearance

Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease

This study is currently recruiting participants.

Verified by The University of North Carolina, Chapel Hill, July 2009

First Received: July 6, 2009 Last Updated: July 7, 2009 History of Changes

Sponsors and Collaborators:	The University of North Carolina, Chapel Hill Cystic Fibrosis Foundation Discovery Laboratories
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00934362

Purpose

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.

Condition	Intervention	Phase
Cystic Fibrosis	Drug: Lucinactant Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Double Blind, Cross-Over Study Comparing Aerosolized Lucinactant and Vehicle on Mucociliary Clearance for Cystic Fibrosis Lung Disease

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Sinapultide Lucinactant

U.S. FDA Resources

Further study details as provided by The University of North Carolina, Chapel Hill:

Primary Outcome Measures:

• Mucociliary clearance rate [ Time Frame: baseline and after 5 doses ] [ Designated as safety issue: No ]
  

Secondary Outcome Measures:

• Spirometry [ Time Frame: acute and after 5 doses ] [ Designated as safety issue: Yes ]
  
• Lung clearance index [ Time Frame: baseline and after 5 doses ] [ Designated as safety issue: No ]
  
• Quality of Life (CFQ-R) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  
• Sputum rheology [ Time Frame: After 5 doses ] [ Designated as safety issue: No ]
  

Estimated Enrollment:	16
Study Start Date:	October 2008
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lucinactant: Experimental	Drug: Lucinactant lucinactant 120 mg (20 mg/ml) x 5 doses over 24 hours
Placebo: Placebo Comparator	Drug: Placebo 6 mL normal saline x 5 doses over 24 hours

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.

Eligibility

Ages Eligible for Study:	14 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934362

Locations

United States, North Carolina
University of North Carolina	Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Scott H Donaldson, MD 919-966-9198 scott_donaldson@med.unc.edu
Contact: Scott H Donaldson, MD 9199669198 scott_donaldson@med.unc.edu

Sponsors and Collaborators

The University of North Carolina, Chapel Hill

Cystic Fibrosis Foundation

Discovery Laboratories

Investigators

Principal Investigator:

Scott H Donaldson, MD

The University of North Carolina, Chapel Hill

More Information
No publications provided

Responsible Party:	University of North Carolina CF Research and Treatment Center ( Scott H. Donaldson, MD )
Study ID Numbers:	08-0795, KL4-CF-01, DONALD04A0
Study First Received:	July 6, 2009
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00934362 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Lung Diseases, Interstitial Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Fibrosis

Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases Pulmonary Fibrosis Pulmonary Surfactants

Additional relevant MeSH terms:

Pulmonary Fibrosis Cystic Fibrosis Fibrosis Lung Diseases, Interstitial Pathologic Processes Digestive System Diseases

Genetic Diseases, Inborn Respiratory Tract Diseases Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases

ClinicalTrials.gov processed this record on July 10, 2009

http://www.clinicaltrials.gov/ct2/show/NCT00934362?term=cystic+fibrosis&recr=Open