Characterization of Airway Mucus in Bronchiectasis Patients and Healthy Controls

NCT03125174 | Completed

• 1 other identifier: 16-3142
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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)

Conditions

Bronchiectasis Adult

Keywords

sputum; bronchiectasis; lung disease

Outcome Measures

Primary Outcomes (1)

• Mucus concentration (% solids)

  The percentage of solid content of sputum (an index of hydration) will be calculated my measuring the wet to dry weight ratio using a microbalance (mean percent solids ± standard deviation).

  6 months

Secondary Outcomes (6)

• Biophysical properties of mucus by rheology

  6 months

• Mucin composition by mass spectroscopy

  6 months

• Sputum extracellular nucleotide analysis

  6 months

• Osmotic Pressure

  6 months

• Total mucin concentration

  6 months

Study Arms (2)

control

healthy individuals with no history of lung disease

bronchiectasis patients

individuals with a diagnoses of bronchiectasis

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (2)

Center for Environmental Medicine Asthma and Lung Biology

Chapel Hill, North Carolina, 27599, United States

Location

Marsico Research Institure at Meadowmont

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

sputum

MeSH Terms

Conditions

Bronchiectasis; Lung Diseases

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Richard Boucher, MD

  University of North Carolina, Chapel Hill

  STUDY CHAIR

• Kathryn Ramsey

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 24, 2017
• Study Start: March 10, 2017
• Primary Completion: June 27, 2017
• Study Completion: June 27, 2017
• Last Updated: July 24, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)