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

May 10, 2020 updated by: Sibel Naycı
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yenisehir
      • Mersin, Yenisehir, Turkey, 33070
        • Mersin University Faculty of Medicine, Department of Respiratory Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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: 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.
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.
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: Chest X Ray
Chest X ray is a radiological examination.
Other: Healthy control group with no smoking history
Impulse oscillometric pulmonary function test, spirometric pulmonary function test and chest x ray will be performed.
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: Chest X Ray
Chest X ray is a radiological examination.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Small airway dysfunction will be evaluated by performing impulse oscillometry test.
Time Frame: 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.
through study completion, an average of 1 year
Small airway dysfunction will be evaluated by thorax computed tomography.
Time Frame: 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).
through study completion, an average of 1 year
Small airway dysfunction will be evaluated by body plethysmography test.
Time Frame: 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.
through study completion, an average of 1 year
Symptoms will be evaluated by Modified Medical Research Council Dyspnea Scale (mMRC).
Time Frame: 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.
through study completion, an average of 1 year
The number of moderate and severe exacerbations over a 1 year period will be recorded.
Time Frame: 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.
through study completion, an average of 1 year
Forced expiratory volume in 1 second (fev1) change will be evaluated by spirometric pulmonary function test.
Time Frame: 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.
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fractional Exhaled Nitric Oxide (FENO) test will be used as an indicator of inflammation.
Time Frame: through study completion, an average of 1 year
FENO test is indirect measurements of inflammation, as used in clinical practice.
through study completion, an average of 1 year
Complete blood count ( CBC) test will be used as an indicator of inflammation.
Time Frame: through study completion, an average of 1 year
Blood eosinophil levels will be recorded.
through study completion, an average of 1 year
Quality of life will be evaluated by COPD Assessment Test (CAT).
Time Frame: through study completion, an average of 1 year
COPD Assessment Test (CAT) contains 8 questions. In each question, the minimum value is zero and the maximum value is five points. Higher score means worse outcome.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sibel Naycı

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mersin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-2-TP3-3539-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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