- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03125174
Characterization of Airway Mucus in Bronchiectasis Patients and Healthy Controls
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599
- Center for Environmental Medicine Asthma and Lung Biology
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Chapel Hill, North Carolina, Forenede Stater, 27599
- Marsico Research Institure at Meadowmont
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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control
healthy individuals with no history of lung disease
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bronchiectasis patients
individuals with a diagnoses of bronchiectasis
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Mucus concentration (% solids)
Tidsramme: 6 months
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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).
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6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Biophysical properties of mucus by rheology
Tidsramme: 6 months
|
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)).
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6 months
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Mucin composition by mass spectroscopy
Tidsramme: 6 months
|
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.
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6 months
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Sputum extracellular nucleotide analysis
Tidsramme: 6 months
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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)).
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6 months
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Osmotic Pressure
Tidsramme: 6 months
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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).
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6 months
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Total mucin concentration
Tidsramme: 6 months
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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.
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6 months
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polymeric DNA concentration
Tidsramme: 6 months
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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)).
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6 months
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Samarbejdspartnere og efterforskere
Efterforskere
- Studiestol: Richard Boucher, MD, University of North Carolina, Chapel Hill
- Ledende efterforsker: Kathryn Ramsey, University of North Carolina, Chapel Hill
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 16-3142
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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