NCT04384133

The Prevalence of Small Airways Dysfunction In COPD Patients and The Impact on COPD Control

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Sibel Naycı · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• COPD
• Small Airway Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Impulse oscillometry	Impulse oscillometry is a pulmonary function test. During the test, the participant is told to breathe normally.
DIAGNOSTIC_TEST	Spirometric pulmonary function test	In the spirometric pulmonary function test, the participant is asked to perform respiratory maneuvers such as breathing deeply.
DIAGNOSTIC_TEST	Fractional exhaled nitric oxide (FENO) test	In the FENO test, the participant is asked to perform respiratory maneuvers such as breathing deeply.
DIAGNOSTIC_TEST	Thorax Computed Tomography	Computed tomography is a radiological examination.
DIAGNOSTIC_TEST	Chest X Ray	Chest X ray is a radiological examination.
DIAGNOSTIC_TEST	Blood eosinophil level	A tube of blood will be drawn from the participant.
OTHER	CAT	It consists of 8 questions.
OTHER	mMRC	It is the scale used to measure the severity of shortness of breath.

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-09-01
• Completion: 2021-04-01
• First posted: 2020-05-12
• Last updated: 2020-05-12

Locations

1 site across 1 country: Turkey (Türkiye)