Characterization of Airway Mucus in Bronchiectasis Patients and Healthy Controls

NCT ID: NCT03125174

Last Updated: 2017-07-24

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

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-10

Study Completion Date

2017-06-27

Brief Summary

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Analysis of mucus, mucin and DNA concentration, MUC5B/5AC ratio, rheology, osmotic pressure, cohesion and nucleotides in sputum on 30 individual samples of good quality in healthy individuals and those with bronchiectasis. (60 total)

Detailed Description

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In this study the investigators will investigate the mucus properties in individuals with idiopathic bronchiectasis and healthy individuals without a history of lung disease. In order to understand how mucus is abnormal in disease conditions, the investigators need to understand the mucus biochemical and biophysical properties in healthy individuals. In this study the investigators will prospectively recruit patients with bronchiectasis and healthy individuals from the community to provide airway sputum samples. In these samples the investigators will measure an array of mucus properties. This will help our understanding of the mucus-obstructive lung diseases and facilitate the development of appropriate and effective disease prevention strategies.

A key question is whether mucus is hyper-concentrated and has abnormal biophysical properties in individuals with mucus-obstructive lung disease. To answer this question, the investigators need to understand the properties of the mucus in individuals with idiopathic bronchiectasis and no history of lung disease. This study will allow us to collect airway mucus (sputum) from individuals with bronchiectasis and healthy individuals with no history of lung disease.

Conditions

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Bronchiectasis Adult

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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control

healthy individuals with no history of lung disease

No interventions assigned to this group

bronchiectasis patients

individuals with a diagnoses of bronchiectasis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Written informed consent
* Bronchiectasis patients: Available CT of the chest that shows evidence of dilated airways fulfilling radiographic criteria for bronchiectasis in more than one lobe and chronic cough.

Participants who meet any of the following criteria will not be eligible for the study:

* Healthy individuals: A history of lung disease, current asthma symptoms or medication use, premature birth (\<37 week gestation), a history of lung disease of infancy, or neurological or cardiovascular illness, current smoker or a history of smoking tobacco products.
* Bronchiectasis patients: Premature birth (\<37 week gestation), a history of lung disease of infancy, or neurological or cardiovascular illness.
* Younger than 18 years of age
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Boucher, MD

Role: STUDY_CHAIR

University of North Carolina, Chapel Hill

Kathryn Ramsey

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Center for Environmental Medicine Asthma and Lung Biology

Chapel Hill, North Carolina, United States

Site Status

Marsico Research Institure at Meadowmont

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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16-3142

Identifier Type: -

Identifier Source: org_study_id

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