Investigating Mucinase Activity in Airway Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00596232
First received: January 2, 2008
Last updated: September 23, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to investigate how mucus (phlegm or spit) is broken down once it forms in the airways (bronchial tubes) of people with lung disease. This research study will also examine whether blood groups have an effect on lung function or the type of mucus found in the lung. This study is not designed to be a treatment for asthma, emphysema, cystic fibrosis, or other lung disease. It is designed to help the investigators learn more about the causes of airway disease.


Condition
Asthma
Cystic Fibrosis
Smokers

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Investigating Mucinase Activity in Airway Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • rheological measurements (viscosity and elasticity) in sputum. [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Sputum


Estimated Enrollment: 225
Study Start Date: April 2003
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asthma
People who have been diagnosed with Asthma
CF
People who have been diagnosed with Cystic Fibrosis
Smokers
People who either have a history of cigarette smoking of at least 10 pack years and current smoking of at least 10 cigarettes a day, or have a history of cigarette smoking of at least 10 pack years and FEV1/FVC ratio less than 0.7.
Healthy
People who are non-asthmatic, non smokers with less than 10 pack years and who do not have cystic fibrosis

Detailed Description:

Accumulation of mucus in the airway involves the process of overproduction and reduced clearance of mucin glycoproteins. To date, little attention has been focused on mechanisms of mucin clearance from the airway. We hypothesize that there is enzymatic degradation of mucins ("mucinase activity") in the airway, which acts to break down mucins and facilitate their clearance. We further hypothesize that glycosidases function as mucinases by removing peripheral monosaccharides from oligosaccharides, including oligosaccharides on mucins. Removal of terminal or capping sugars on mucin side chains may be an important mechanism in mucin degradation and clearance from the lung. If mucinase activity exists in the airway then mucus collected from human subjects should demonstrate evidence of mucin degradation ex vivo, especially at 37ºC. As part of our protocol we propose to examine changes in airway mucus ex vivo under different experimental conditions. Our primary readout will be measures of sputum rheology, namely viscosity and elasticity. Our consultant for this methodology will be Dr Susan Muller (Chemical Engineering, UC Berkeley). In order to conduct experimental studies in this way we will need multiple samples from the same subjects. Thus, up to 10 or more sputum samples per subject will be collected on different days. In addition, we are interested in the biochemical properties of sputum and saliva, specifically the composition of mucin molecules found in these fluids.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Volunteers are recruited from community advertisements and health clinics

Criteria

Inclusion Criteria:

Asthma:

  1. Male and female subjects aged 18 - 70 years
  2. Medical history consistent with asthma
  3. PC20 methacholine ≤ 8 mg/ml for subjects not taking inhaled corticosteroids
  4. PC20 methacholine ≤ 16 mg/ml for subjects taking inhaled corticosteroids
  5. Ability to provide informed consent

Smokers:

  1. Male and female subjects aged 18 - 70 years
  2. A history of cigarette smoking of at least 10 pack years and current smoking of at least 10 cigarettes a day, or a history of cigarette smoking of at least 10 pack years and FEV1/FVC ratio less than 0.7.
  3. FEV1 > 40% predicted
  4. Ability to provide informed consent

Cystic Fibrosis:

  1. Male and female subjects aged 18-55 years
  2. Prior diagnosis of cystic fibrosis
  3. Ability to provide informed consent

Healthy:

  1. Male and female subjects aged 18-70 years
  2. No current smoking history
  3. No history of asthma or allergic rhinitis
  4. FEV1 > 80% predicted
  5. Ability to provide informed consent

Exclusion Criteria:

  1. Recent heart attack or stroke
  2. Known aortic or cerebral aneurysm
  3. Uncontrolled hypertension
  4. Pregnancy
  5. Lactation
  6. Lung disease other than asthma,cystic fibrosis, or COPD/emphysema/chronic bronchitis
  7. Upper- or lower-respiratory tract infection 6 weeks prior to study enrollment
  8. Significant asthma exacerbation 6 weeks prior to study enrollment
  9. Increasing hyposensitization therapy for the past 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596232

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

Locations
United States, California
UCSF Airway Clinical Research Center 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, M.D., M.Sc. University of California, San Francisco
  More Information

Additional Information:
No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00596232     History of Changes
Other Study ID Numbers: 11-05418
Study First Received: January 2, 2008
Last Updated: September 23, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Cystic Fibrosis
Fibrosis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 19, 2014