Investigating Mucinase Activity in Airway Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

211 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-04-30

Study Completion Date

2016-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Genetic Disorders of Mucociliary Clearance in Nontuberculous Mycobacterial Lung Disease

NCT00368446

Cystic Fibrosis Pseudohypoaldosteronism Nontuberculous Mycobacterial Infection +2 more

COMPLETED

Characterizing Asthma Sputum Elasticity in the UCSF Severe Asthma Research Program

NCT02103348

Asthma

COMPLETED

Characterization of Airway Mucus in Bronchiectasis Patients and Healthy Controls

NCT03125174

Bronchiectasis Adult

COMPLETED

The Role of Airway Microbiota on Clinical Phenotypes and Disease Severity in Bronchiectasis

NCT05068518

Bronchiectasis Adult

UNKNOWN

Impact of Metabolic Dysfunction and Mucus Plugging on Asthma Physiology

NCT05757583

Asthma

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Cystic Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Asthma

People who have been diagnosed with Asthma

No interventions assigned to this group

Cystic Fibrosis

People who have been diagnosed with Cystic Fibrosis

No interventions assigned to this group

Healthy

People who are non-asthmatic, non smokers with less than 10 pack years and who do not have cystic fibrosis

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Asthma:

1. Male and female subjects aged 18 - 70 years
2. Medical history consistent with asthma
3. PC20 (provocative concentration causing a 20% fall) 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

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 (forced expiratory volume in 1 second) \> 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 chronic obstructive pulmonary disease (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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes