- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00596232
Investigating Mucinase Activity in Airway Disease (Mucinase)
April 28, 2016 updated by: University of California, San Francisco
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.
Study Overview
Status
Completed
Conditions
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 37º celsius.
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, University of California, 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.
Study Type
Observational
Enrollment (Actual)
211
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Francisco, California, United States, 94143
- UCSF Airway Clinical Research Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Volunteers are recruited from community advertisements and health clinics
Description
Inclusion Criteria:
Asthma:
- Male and female subjects aged 18 - 70 years
- Medical history consistent with asthma
- PC20 (provocative concentration causing a 20% fall) methacholine ≤ 8 mg/ml for subjects not taking inhaled corticosteroids
- PC20 methacholine ≤ 16 mg/ml for subjects taking inhaled corticosteroids
- Ability to provide informed consent
Cystic Fibrosis:
- Male and female subjects aged 18-55 years
- Prior diagnosis of cystic fibrosis
- Ability to provide informed consent
Healthy:
- Male and female subjects aged 18-70 years
- No current smoking history
- No history of asthma or allergic rhinitis
- FEV1 (forced expiratory volume in 1 second) > 80% predicted
- Ability to provide informed consent
Exclusion Criteria:
- Recent heart attack or stroke
- Known aortic or cerebral aneurysm
- Uncontrolled hypertension
- Pregnancy
- Lactation
- Lung disease other than asthma,cystic fibrosis, or chronic obstructive pulmonary disease (COPD)/emphysema/chronic bronchitis
- Upper- or lower-respiratory tract infection 6 weeks prior to study enrollment
- Significant asthma exacerbation 6 weeks prior to study enrollment
- Increasing hyposensitization therapy for the past 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Asthma
People who have been diagnosed with Asthma
|
Cystic Fibrosis
People who have been diagnosed with Cystic Fibrosis
|
Healthy
People who are non-asthmatic, non smokers with less than 10 pack years and who do not have cystic fibrosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
rheological measurements (viscosity and elasticity) in sputum.
Time Frame: 2-3 years
|
2-3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: John V Fahy, M.D., M.Sc., University of California, San Francisco
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
January 2, 2008
First Submitted That Met QC Criteria
January 15, 2008
First Posted (Estimate)
January 16, 2008
Study Record Updates
Last Update Posted (Estimate)
May 2, 2016
Last Update Submitted That Met QC Criteria
April 28, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-05418
- 5P01HL107202-03 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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