- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03125174
Characterization of Airway Mucus in Bronchiectasis Patients and Healthy Controls
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599
- Center for Environmental Medicine Asthma and Lung Biology
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Chapel Hill, North Carolina, 미국, 27599
- Marsico Research Institure at Meadowmont
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mucus concentration (% solids)
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Biophysical properties of mucus by rheology
기간: 6 months
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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
기간: 6 months
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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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 연구 의자: Richard Boucher, MD, University of North Carolina, Chapel Hill
- 수석 연구원: Kathryn Ramsey, University of North Carolina, Chapel Hill
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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