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Sunday, July 12, 2009

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:


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

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