Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-31 @ 1:04 PM
Study NCT ID:
NCT04384133
Status:
UNKNOWN
Last Update Posted:
2020-05-12
First Post:
2020-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prevalence of Small Airways Dysfunction In COPD Patients and The Impact on COPD Control
Sponsor:
Sibel Naycı
Organization:
Study Overview
Official Title:
The Prevalence of Small Airways Dysfunction In COPD Patients and The Impact on COPD Control
Status:
UNKNOWN
Status Verified Date:
2020-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: