Preventing Fucose-dependent Binding of Aspergillus and Pseudomonas to Lung Mucin (CADET)

This study is currently recruiting participants.
Verified January 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
John V. Fahy, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01533636
First received: February 10, 2012
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

The investigators will collect samples of sputum from healthy volunteers and patients with cystic fibrosis for the purpose of: a) purifying airway mucins for plate-based binding studies and; b) assessment of the effects of carbohydrates on the rheologic properties of the sputum.

This study has two hypotheses:

  1. Lectins from Pseudomonas aeruginosa and Aspergillus fumigatus bind to airway mucins in a fucose-dependent manner, and this binding can be inhibited by fucosyl glycomimetic compounds.
  2. Fucosyl glycomimetics will compete with Pseudomonas aeruginosa lectin (PA-IIL) and Aspergillus fumigatus lectin (AFL) and disrupt lectin-driven mucin cross-linking in CF sputum.

Condition
Cystic Fibrosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Preventing Fucose-dependent Binding of Aspergillus and Pseudomonas to Lung Mucin

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Mucus viscosity [ Time Frame: Up to one hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy Control
Cystic Fibrosis

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Cystic Fibrosis and Healthy Controls

Criteria

Inclusion Criteria:

  • Healthy control subjects:

    • Age 18-65
    • No history of lung disease
  • Cystic fibrosis subjects:

    • Age 18-65
    • No history of lung disease other than cystic fibrosis
    • Diagnosis of CF if sweat chloride values > 60 mM on two separate pilocarpine iontophoresis sweat tests and/or two allelic CF-producing mutations in genetic analysis

Exclusion Criteria:

  • Use of recreational drugs within 30 days prior to enrollment
  • Use of tobacco within 30 days prior to enrollment, or > 10 pack-year tobacco history
  • Pregnant or lactating females
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533636

Contacts
Contact: Kelly Norsworthy, BA 415-502-8791 kelly.norsworthy@ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Kelly Norsworthy, BA    415-502-8791    kelly.norsworthy@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: John V Fahy, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: John V. Fahy, Professor in Residence, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01533636     History of Changes
Other Study ID Numbers: 10-04834
Study First Received: February 10, 2012
Last Updated: January 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Cystic Fibrosis, Healthy

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pseudomonas Infections
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 22, 2014