Clinical trial NCT03125174: Characterization of Airway Mucus in Bronchiectasis Patients and Healthy Controls
Official title: Characterization of Airway Mucus in Bronchiectasis Patients and Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchiectasis Adult
Keywords: sputum
bronchiectasis
lung disease
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The proposed study will recruit 30 patients with bronchiectasis and 30 healthy individuals with no history of lung disease aged over the age of 18 years.

Brief summary: 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: 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.

Eligibility criteria: Participants who meet all the following criteria are eligible for the study:

* 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

Primary outcomes:
measure: Mucus concentration (% solids)
timeFrame: 6 months
Secondary outcomes:
measure: Biophysical properties of mucus by rheology
timeFrame: 6 months
measure: Mucin composition by mass spectroscopy
timeFrame: 6 months
measure: Sputum extracellular nucleotide analysis
timeFrame: 6 months
measure: Osmotic Pressure
timeFrame: 6 months
measure: Total mucin concentration
timeFrame: 6 months
measure: polymeric DNA concentration
timeFrame: 6 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Center for Environmental Medicine Asthma and Lung Biology
state: North Carolina
city: Chapel Hill
country: United States
facility: Marsico Research Institure at Meadowmont
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Richard Boucher, MD
role: STUDY_CHAIR
affiliation: University of North Carolina, Chapel Hill
name: Kathryn Ramsey
role: PRINCIPAL_INVESTIGATOR
References: