The Prevalence of Small Airways Dysfunction In COPD Patients and The Impact on COPD Control
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Small airway dysfunction will be evaluated by performing impulse oscillometry test.
研究概览
简要总结
Chronic obstructive pulmonary disease (COPD) is a worldwide prevalent disease. During recent years, increasing attention has been directed to the importance of the contribution of small airways in respiratory diseases. The small airways (usually defined as those with an internal diameter of <2 mm) are recognized as the major site of resistance to airflow in obstructive lung disease. Although small airway disease is known in chronic airway diseases, the importance of small airway dysfunction on disease control, exacerbations and quality of life, and the importance of taking place among treatable targets is not clear. Therefore, our aim in the study is to determine the frequency of small airway dysfunction in COPD. Our secondary aim is to evaluate the role of small airway dysfunction in disease severity, disease phenotypes, disease control, quality of life and its effect on predicting the risk of exacerbation and its role among treatable targets in chronic airway diseases.
详细描述
This is a prospective cross-sectional interventional design. 100 COPD patients who applied to Mersin University Faculty of Medicine Hospital Chest Diseases Clinic between 01.10.2019-01.04.2020 will be taken. 35 healthy participants with smoking history and 35 healthy participants without smoking history who were admitted to our clinic within the same date range will be taken as control group. Impulse oscillometric pulmonary function tests will be performed to all participants. Thorax computed tomography will be performed to evaluate small airway dysfunction. To evaluate the degree of disease inflammation and phenotype in COPD patients, nitric oxide measurements will be made in the breath air with fractional exhaled nitric oxide (FENO) device. The blood eosinophil level will be studied to determine the COPD phenotype. To assess symptom control in patients with COPD, mMRC(Modified Medical Research Council) dyspnea scale will be administered. The COPD assessment test (CAT) will be applied to measure the quality of life. All patients will be followed for 1 year to record the number of exacerbations requiring emergency and hospital admissions for COPD. The effect of small airway dysfunction on the disease severity and control degree, disease phenotypes and quality of life, and the effect on the risk of exacerbation will be analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who applied to the chest diseases clinic of Mersin University Hospital, between October 1, 2019 and April 1, 2020
- •Participants who were diagnosed COPD with spirometry test
- •Reading and signing Informed Consent Form
- •Participants must be older than 18 years
- •Healthy control group with a history of smoking
- •To apply to the chest diseases clinic of Mersin University Hospital between October 1, 2019 and April 1, 2020
- •Reading and signing informed consent form
- •Participants must be older than 18 years
- •Must have no lung disease
- •Must have 10 packs / year or more than 10 packs / year smoking history
- •Healthy control group without smoking history
- •To apply to the chest diseases clinic of Mersin University Hospital between October 1, 2019 and April 1, 2020
- •Reading and signing informed consent form
- •Participants must be older than 18 years
- •Must have no lung disease
- •Must have no smoking history
排除标准
- •Participants who do not sign the Informed Consent Form
- •Under the age of 18 years
- •Pregnant women
- •Participants who with a history of cancer in the past 5 years
- •Participants who previously had lung surgery
- •Participants who with Interstitial Lung Disease
- •Participants who with respiratory muscle disease
- •Participants who with active pulmonary tuberculosis
- •Participants who can not perform respiratory function tests
研究组 & 干预措施
COPD group
Impulse oscillometric pulmonary function tests and spirometric pulmonary function test will be performed.To evaluate the degree of disease inflammation and phenotype, nitric oxide measurements will be made in the breath air with fractional exhaled nitric oxide (FENO) device. Blood eosinophil values will be examined. Thorax computed tomography will be performed to evaluate small airway dysfunction. To assess symptom control in patients with COPD, a dyspnea scale of mMRC will be administered. The COPD assessment test (CAT) will be applied to measure the quality of life. All participants will be followed for 1 year to record the number of exacerbations requiring emergency and hospital admissions for COPD.
干预措施: CAT (Other)
COPD group
Impulse oscillometric pulmonary function tests and spirometric pulmonary function test will be performed.To evaluate the degree of disease inflammation and phenotype, nitric oxide measurements will be made in the breath air with fractional exhaled nitric oxide (FENO) device. Blood eosinophil values will be examined. Thorax computed tomography will be performed to evaluate small airway dysfunction. To assess symptom control in patients with COPD, a dyspnea scale of mMRC will be administered. The COPD assessment test (CAT) will be applied to measure the quality of life. All participants will be followed for 1 year to record the number of exacerbations requiring emergency and hospital admissions for COPD.
干预措施: Blood eosinophil level (Diagnostic Test)
COPD group
Impulse oscillometric pulmonary function tests and spirometric pulmonary function test will be performed.To evaluate the degree of disease inflammation and phenotype, nitric oxide measurements will be made in the breath air with fractional exhaled nitric oxide (FENO) device. Blood eosinophil values will be examined. Thorax computed tomography will be performed to evaluate small airway dysfunction. To assess symptom control in patients with COPD, a dyspnea scale of mMRC will be administered. The COPD assessment test (CAT) will be applied to measure the quality of life. All participants will be followed for 1 year to record the number of exacerbations requiring emergency and hospital admissions for COPD.
干预措施: Impulse oscillometry (Diagnostic Test)
COPD group
Impulse oscillometric pulmonary function tests and spirometric pulmonary function test will be performed.To evaluate the degree of disease inflammation and phenotype, nitric oxide measurements will be made in the breath air with fractional exhaled nitric oxide (FENO) device. Blood eosinophil values will be examined. Thorax computed tomography will be performed to evaluate small airway dysfunction. To assess symptom control in patients with COPD, a dyspnea scale of mMRC will be administered. The COPD assessment test (CAT) will be applied to measure the quality of life. All participants will be followed for 1 year to record the number of exacerbations requiring emergency and hospital admissions for COPD.
干预措施: Spirometric pulmonary function test (Diagnostic Test)
COPD group
Impulse oscillometric pulmonary function tests and spirometric pulmonary function test will be performed.To evaluate the degree of disease inflammation and phenotype, nitric oxide measurements will be made in the breath air with fractional exhaled nitric oxide (FENO) device. Blood eosinophil values will be examined. Thorax computed tomography will be performed to evaluate small airway dysfunction. To assess symptom control in patients with COPD, a dyspnea scale of mMRC will be administered. The COPD assessment test (CAT) will be applied to measure the quality of life. All participants will be followed for 1 year to record the number of exacerbations requiring emergency and hospital admissions for COPD.
干预措施: Fractional exhaled nitric oxide (FENO) test (Diagnostic Test)
COPD group
Impulse oscillometric pulmonary function tests and spirometric pulmonary function test will be performed.To evaluate the degree of disease inflammation and phenotype, nitric oxide measurements will be made in the breath air with fractional exhaled nitric oxide (FENO) device. Blood eosinophil values will be examined. Thorax computed tomography will be performed to evaluate small airway dysfunction. To assess symptom control in patients with COPD, a dyspnea scale of mMRC will be administered. The COPD assessment test (CAT) will be applied to measure the quality of life. All participants will be followed for 1 year to record the number of exacerbations requiring emergency and hospital admissions for COPD.
干预措施: Thorax Computed Tomography (Diagnostic Test)
COPD group
Impulse oscillometric pulmonary function tests and spirometric pulmonary function test will be performed.To evaluate the degree of disease inflammation and phenotype, nitric oxide measurements will be made in the breath air with fractional exhaled nitric oxide (FENO) device. Blood eosinophil values will be examined. Thorax computed tomography will be performed to evaluate small airway dysfunction. To assess symptom control in patients with COPD, a dyspnea scale of mMRC will be administered. The COPD assessment test (CAT) will be applied to measure the quality of life. All participants will be followed for 1 year to record the number of exacerbations requiring emergency and hospital admissions for COPD.
干预措施: mMRC (Other)
Healthy control group with a history of smoking
Impulse oscillometric pulmonary function test, spirometric pulmonary function test and chest x ray will be performed.
干预措施: Impulse oscillometry (Diagnostic Test)
Healthy control group with a history of smoking
Impulse oscillometric pulmonary function test, spirometric pulmonary function test and chest x ray will be performed.
干预措施: Spirometric pulmonary function test (Diagnostic Test)
Healthy control group with a history of smoking
Impulse oscillometric pulmonary function test, spirometric pulmonary function test and chest x ray will be performed.
干预措施: Chest X Ray (Diagnostic Test)
Healthy control group with no smoking history
Impulse oscillometric pulmonary function test, spirometric pulmonary function test and chest x ray will be performed.
干预措施: Impulse oscillometry (Diagnostic Test)
Healthy control group with no smoking history
Impulse oscillometric pulmonary function test, spirometric pulmonary function test and chest x ray will be performed.
干预措施: Spirometric pulmonary function test (Diagnostic Test)
Healthy control group with no smoking history
Impulse oscillometric pulmonary function test, spirometric pulmonary function test and chest x ray will be performed.
干预措施: Chest X Ray (Diagnostic Test)
结局指标
主要结局
Small airway dysfunction will be evaluated by performing impulse oscillometry test.
时间窗: through study completion, an average of 1 year
Respiratory resistance at 5 and 20 Hz (R5 and R20, respectively) will be used for the analyses. R5 and R20 are regarded as reflecting total and proximal airway resistance, respectively, and the fall in resistance from R5 to R20 (R5-R20) will used as a surrogate for the resistance of small airways.
Small airway dysfunction will be evaluated by thorax computed tomography.
时间窗: through study completion, an average of 1 year
Indirect changes caused by the small airways on the lung parenchyma will be detected by computed tomography (CT).
Symptoms will be evaluated by Modified Medical Research Council Dyspnea Scale (mMRC).
时间窗: through study completion, an average of 1 year
The mMRC (Modified Medical Research Council) scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing.
Forced expiratory volume in 1 second (fev1) change will be evaluated by spirometric pulmonary function test.
时间窗: through study completion, an average of 1 year
Forced expiratory volume in 1 second (fev1) change over one year period will be evaluated with spirometric pulmonary function test during recruitment and 1st year of follow-up.
Small airway dysfunction will be evaluated by body plethysmography test.
时间窗: through study completion, an average of 1 year
Residual volume (RV) and total lung capacity (TLC) will be measured by body plethysmography test to determine small airway dysfunction.
The number of moderate and severe exacerbations over a 1 year period will be recorded.
时间窗: through study completion, an average of 1 year
In the COPD group, each participant will be followed for 1 year in terms of recording exacerbations.
次要结局
- Complete blood count ( CBC) test will be used as an indicator of inflammation.(through study completion, an average of 1 year)
- Fractional Exhaled Nitric Oxide (FENO) test will be used as an indicator of inflammation.(through study completion, an average of 1 year)
- Quality of life will be evaluated by COPD Assessment Test (CAT).(through study completion, an average of 1 year)
研究者
Sibel Naycı
Clinical Professor of Pulmonology
Mersin University