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

NCT04384133 | Unknown DMC

• 1 other identifier: 2019-2-TP3-3539-2
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Small Airway Disease

Keywords

COPD; Small Airway Dysfunction; Impulse oscillometry

Outcome Measures

Primary Outcomes (6)

• Small airway dysfunction will be evaluated by performing impulse oscillometry test.

  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.

  through study completion, an average of 1 year

• Small airway dysfunction will be evaluated by thorax computed tomography.

  Indirect changes caused by the small airways on the lung parenchyma will be detected by computed tomography (CT).

  through study completion, an average of 1 year

• Small airway dysfunction will be evaluated by body plethysmography test.

  Residual volume (RV) and total lung capacity (TLC) will be measured by body plethysmography test to determine small airway dysfunction.

  through study completion, an average of 1 year

• Symptoms will be evaluated by Modified Medical Research Council Dyspnea Scale (mMRC).

  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.

  through study completion, an average of 1 year

• The number of moderate and severe exacerbations over a 1 year period will be recorded.

  In the COPD group, each participant will be followed for 1 year in terms of recording exacerbations.

  through study completion, an average of 1 year

• Forced expiratory volume in 1 second (fev1) change will be evaluated by spirometric pulmonary function test.

  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.

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Fractional Exhaled Nitric Oxide (FENO) test will be used as an indicator of inflammation.

  through study completion, an average of 1 year

• Complete blood count ( CBC) 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

Study Arms (3)

COPD group

OTHER

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.

Diagnostic Test: Impulse oscillometry; Diagnostic Test: Spirometric pulmonary function test; Diagnostic Test: Fractional exhaled nitric oxide (FENO) test; Diagnostic Test: Thorax Computed Tomography; Diagnostic Test: Blood eosinophil level; Other: CAT; Other: mMRC

Healthy control group with a history of smoking

OTHER

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

Diagnostic Test: Impulse oscillometry; Diagnostic Test: Spirometric pulmonary function test; Diagnostic Test: Chest X Ray

Healthy control group with no smoking history

OTHER

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

Diagnostic Test: Impulse oscillometry; Diagnostic Test: Spirometric pulmonary function test; Diagnostic Test: Chest X Ray

Interventions

Impulse oscillometry DIAGNOSTIC_TEST

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

COPD group; Healthy control group with a history of smoking; Healthy control group with no smoking history

Spirometric pulmonary function test DIAGNOSTIC_TEST

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

COPD group; Healthy control group with a history of smoking; Healthy control group with no smoking history

Fractional exhaled nitric oxide (FENO) test DIAGNOSTIC_TEST

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

COPD group

Thorax Computed Tomography DIAGNOSTIC_TEST

Computed tomography is a radiological examination.

COPD group

Chest X Ray DIAGNOSTIC_TEST

Chest X ray is a radiological examination.

Healthy control group with a history of smoking; Healthy control group with no smoking history

Blood eosinophil level DIAGNOSTIC_TEST

A tube of blood will be drawn from the participant.

COPD group

CAT OTHER

It consists of 8 questions.

COPD group

mMRC OTHER

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

COPD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sibel Naycı: lead
• Mersin University: collaborator

Study Sites (1)

Mersin University Faculty of Medicine, Department of Respiratory Diseases

Mersin, Yenisehir, 33070, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 27852080 BACKGROUND

• 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.

  PMID: 26037949 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fractional Exhaled Nitric Oxide Testing; Diagnostic Imaging

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Breath Tests; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sibel Nayci, Prof.Dr.

  Mersin University, Department of Respiratory Diseases

  STUDY CHAIR

• Demet Polat Yulug, Dr.

  Mersin University, Department of Respiratory Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor of Pulmonology

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 12, 2020
• Study Start: October 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: April 1, 2021
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)