Bronchiectasis AdultNCT03125174
Characterization of Airway Mucus in Bronchiectasis Patients and Healthy Controls
An observational study of Bronchiectasis Adult, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis Adult
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Mar 2017to 27 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Environmental Medicine Asthma and Lung Biology
Chapel Hill, North Carolina, 27599
Marsico Research Institure at Meadowmont
Chapel Hill, North Carolina, 27599
About this study
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)
Read the 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.
- Conditions
- Bronchiectasis Adult
- Keywords
- sputum, bronchiectasis, lung disease
- Medical subject headings
- Bronchiectasis, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| control | healthy individuals with no history of lung disease | |
| bronchiectasis patients | individuals with a diagnoses of bronchiectasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (6)
Biophysical properties of mucus by rheology
The rheological properties of the sputum will be assayed by macro-rheology (cone and plate) and microbead rheology. Macro-rheology provides measures of the viscosity (median log viscosity in Pascal (range)) and elasticity (median log elasticity in Pascal (range) of the sputum. Microbead rheology is performed by analyzing the diffusive motion of embedded 1μm tracer particles (6). The primary outcome measure from microbead rheology will be the mean square displacement MSD(Mean squared displacement) (median MSD cm2 s-1 (range)).
Measured: 6 months
Mucin composition by mass spectroscopy
We will use mass spectroscopy to determine the relative abundance of the two major polymeric mucin proteins, MUC5B(Mucin type 5B)and MUC5AC(Mucin type 5AC), which are responsible for the viscoelastic properties of mucus.
Measured: 6 months
Sputum extracellular nucleotide analysis
Sputum adenosine and adenine nucleotides will be ethenoderivatized and measured by HPLC(High performance liquid chromatography) analysis (7) (median nucleotide concentration in μg/ml (range)).
Measured: 6 months
Osmotic Pressure
The osmotic pressure of the mucus will be assessed by placing an aliquot of mucus onto an osmometer with a 10kDa (10 kilodaltons) molecular weight polyethersulfone membrane (Millipore) separating the test chamber and reference chamber filled with PBS (phosphate-buffered saline) (mean osmotic pressure in Pascal ± standard deviation).
Measured: 6 months
Total mucin concentration
Mucins will be quantitated using sepharose CL2B(Cross-linked derivative of Sepharose 2B) UPLC(Ultra performance liquid chromatography) coupled to an Optilab interference refractometer with a filter at 680 nm and parallel flow chambers for solvent and the solution (mean mucin concentration (μg/ml) ± standard deviation) (4). With this approach, we will ensure that the solute is at full Donnan equilibrium with the solution within the context of gel chromatography, which creates an accurate equilibration of solute and solvent. This procedure also separates the mucins from contaminating proteins, allowing the mucins to be isolated for biochemical studies. DNAse can be added if significant DNA is present.
Measured: 6 months
polymeric DNA concentration
The quantification of free DNA will be performed using the DNA Quant-iT PicoGreen assay (Molecular Probes, Inc., Eugene, OR, USA), which utilizes an ultra-sensitive fluorescent nucleic acid stain for quantitating double-stranded DNA (median log DNA concentration (μg/ml) (range)).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start10 Mar 2017
- Primary completion27 Jun 2017
- Study completion27 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Boucher, MD, Study chair, University of North Carolina, Chapel HillKathryn Ramsey, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125174
- Sponsor's protocol ID
- 16-3142
- Status last verified
- Jul 2017
- First submitted
- 14 Apr 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Airway Mucus in Bronchiectasis Patients and Healthy Controls
- ClinicalTrials.gov ID
- NCT03125174
- Acronym / sponsor ID
- 16-3142
- Conditions
- Bronchiectasis Adult
- Keywords
- sputum, bronchiectasis, lung disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 27 Jun 2017 (actual)
- Study completion
- 27 Jun 2017 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | –healthy individuals with no history of lung disease |
| bronchiectasis patients | – | –individuals with a diagnoses of bronchiectasis |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mucus concentration (% solids)
Time frame: 6 months
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 secondary outcomes
Biophysical properties of mucus by rheology
Time frame: 6 months
Mucin composition by mass spectroscopy
Time frame: 6 months
Sputum extracellular nucleotide analysis
Time frame: 6 months
Osmotic Pressure
Time frame: 6 months
Total mucin concentration
Time frame: 6 months
polymeric DNA concentration
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Boucher, MD study chair
University of North Carolina, Chapel Hill
Kathryn Ramsey principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis Adult, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucus concentration (% solids) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2017.