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

NCT ID: NCT04384133

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-04-01

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.

Conditions

COPD; Small Airway Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Impulse oscillometry

Intervention Type: DIAGNOSTIC_TEST

Impulse oscillometry is a pulmonary function test. During the test, the participant is told to breathe normally.

Spirometric pulmonary function test

Intervention Type: DIAGNOSTIC_TEST

In the spirometric pulmonary function test, the participant is asked to perform respiratory maneuvers such as breathing deeply.

Fractional exhaled nitric oxide (FENO) test

Intervention Type: DIAGNOSTIC_TEST

In the FENO test, the participant is asked to perform respiratory maneuvers such as breathing deeply.

Thorax Computed Tomography

Intervention Type: DIAGNOSTIC_TEST

Computed tomography is a radiological examination.

Blood eosinophil level

Intervention Type: DIAGNOSTIC_TEST

A tube of blood will be drawn from the participant.

CAT

Intervention Type: OTHER

It consists of 8 questions.

mMRC

Intervention Type: OTHER

It is the scale used to measure the severity of shortness of breath.

Healthy control group with a history of smoking

Impulse oscillometric pulmonary function test, spirometric pulmonary function test and chest x ray will be performed.

Group Type: OTHER

Impulse oscillometry

Intervention Type: DIAGNOSTIC_TEST

Impulse oscillometry is a pulmonary function test. During the test, the participant is told to breathe normally.

Spirometric pulmonary function test

Intervention Type: DIAGNOSTIC_TEST

In the spirometric pulmonary function test, the participant is asked to perform respiratory maneuvers such as breathing deeply.

Chest X Ray

Intervention Type: DIAGNOSTIC_TEST

Chest X ray is a radiological examination.

Healthy control group with no smoking history

Impulse oscillometric pulmonary function test, spirometric pulmonary function test and chest x ray will be performed.

Group Type: OTHER

Impulse oscillometry

Intervention Type: DIAGNOSTIC_TEST

Impulse oscillometry is a pulmonary function test. During the test, the participant is told to breathe normally.

Spirometric pulmonary function test

Intervention Type: DIAGNOSTIC_TEST

In the spirometric pulmonary function test, the participant is asked to perform respiratory maneuvers such as breathing deeply.

Chest X Ray

Intervention Type: DIAGNOSTIC_TEST

Chest X ray is a radiological examination.

Interventions

Impulse oscillometry

Impulse oscillometry is a pulmonary function test. During the test, the participant is told to breathe normally.

Intervention Type: DIAGNOSTIC_TEST

Spirometric pulmonary function test

In the spirometric pulmonary function test, the participant is asked to perform respiratory maneuvers such as breathing deeply.

Intervention Type: DIAGNOSTIC_TEST

Fractional exhaled nitric oxide (FENO) test

In the FENO test, the participant is asked to perform respiratory maneuvers such as breathing deeply.

Intervention Type: DIAGNOSTIC_TEST

Thorax Computed Tomography

Computed tomography is a radiological examination.

Intervention Type: DIAGNOSTIC_TEST

Chest X Ray

Chest X ray is a radiological examination.

Intervention Type: DIAGNOSTIC_TEST

Blood eosinophil level

A tube of blood will be drawn from the participant.

Intervention Type: DIAGNOSTIC_TEST

CAT

It consists of 8 questions.

Intervention Type: OTHER

mMRC

It is the scale used to measure the severity of shortness of breath.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

COPD group

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mersin University

OTHER

Sponsor Role: collaborator

Sibel Naycı

OTHER

Sponsor Role: lead

Responsible Party

Sibel Naycı

Clinical Professor of Pulmonology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sibel Nayci, Prof.Dr.

Role: STUDY_CHAIR

Mersin University, Department of Respiratory Diseases

Demet Polat Yulug, Dr.

Role: PRINCIPAL_INVESTIGATOR

Mersin University, Department of Respiratory Diseases

Locations

Mersin University Faculty of Medicine, Department of Respiratory Diseases

Mersin, Yenisehir, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Crisafulli E, Pisi R, Aiello M, Vigna M, Tzani P, Torres A, Bertorelli G, Chetta A. Prevalence of Small-Airway Dysfunction among COPD Patients with Different GOLD Stages and Its Role in the Impact of Disease. Respiration. 2017;93(1):32-41. doi: 10.1159/000452479. Epub 2016 Nov 17.

Reference Type: BACKGROUND

PMID: 27852080 (View on PubMed)

Bonini M, Usmani OS. The role of the small airways in the pathophysiology of asthma and chronic obstructive pulmonary disease. Ther Adv Respir Dis. 2015 Dec;9(6):281-93. doi: 10.1177/1753465815588064. Epub 2015 Jun 2.

Reference Type: BACKGROUND

PMID: 26037949 (View on PubMed)

Other Identifiers

2019-2-TP3-3539-2

Identifier Type: -

Identifier Source: org_study_id