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

Primary Purpose

COPD, Small Airway Disease

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Impulse oscillometry
Spirometric pulmonary function test
Fractional exhaled nitric oxide (FENO) test
Thorax Computed Tomography
Chest X Ray
Blood eosinophil level
CAT
mMRC
Sponsored by
Sibel Naycı
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COPD focused on measuring COPD, Small Airway Dysfunction, Impulse oscillometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Mersin University Faculty of Medicine, Department of Respiratory Diseases

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

COPD group

Healthy control group with a history of smoking

Healthy control group with no smoking history

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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.
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).
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.
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.
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.
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.

Secondary Outcome Measures

Fractional Exhaled Nitric Oxide (FENO) test will be used as an indicator of inflammation.
FENO test is indirect measurements of inflammation, as used in clinical practice.
Complete blood count ( CBC) test will be used as an indicator of inflammation.
Blood eosinophil levels will be recorded.
Quality of life will be evaluated by COPD Assessment Test (CAT).
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.

Full Information

First Posted
May 6, 2020
Last Updated
May 10, 2020
Sponsor
Sibel Naycı
Collaborators
Mersin University
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1. Study Identification

Unique Protocol Identification Number
NCT04384133
Brief Title
The Prevalence of Small Airways Dysfunction In COPD Patients and The Impact on COPD Control
Official Title
The Prevalence of Small Airways Dysfunction In COPD Patients and The Impact on COPD Control
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
April 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sibel Naycı
Collaborators
Mersin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Small Airway Disease
Keywords
COPD, Small Airway Dysfunction, Impulse oscillometry

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COPD group
Arm Type
Other
Arm Description
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.
Arm Title
Healthy control group with a history of smoking
Arm Type
Other
Arm Description
Impulse oscillometric pulmonary function test, spirometric pulmonary function test and chest x ray will be performed.
Arm Title
Healthy control group with no smoking history
Arm Type
Other
Arm Description
Impulse oscillometric pulmonary function test, spirometric pulmonary function test and chest x ray will be performed.
Intervention Type
Diagnostic Test
Intervention Name(s)
Impulse oscillometry
Intervention Description
Impulse oscillometry is a pulmonary function test. During the test, the participant is told to breathe normally.
Intervention Type
Diagnostic Test
Intervention Name(s)
Spirometric pulmonary function test
Intervention Description
In the spirometric pulmonary function test, the participant is asked to perform respiratory maneuvers such as breathing deeply.
Intervention Type
Diagnostic Test
Intervention Name(s)
Fractional exhaled nitric oxide (FENO) test
Intervention Description
In the FENO test, the participant is asked to perform respiratory maneuvers such as breathing deeply.
Intervention Type
Diagnostic Test
Intervention Name(s)
Thorax Computed Tomography
Intervention Description
Computed tomography is a radiological examination.
Intervention Type
Diagnostic Test
Intervention Name(s)
Chest X Ray
Intervention Description
Chest X ray is a radiological examination.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood eosinophil level
Intervention Description
A tube of blood will be drawn from the participant.
Intervention Type
Other
Intervention Name(s)
CAT
Intervention Description
It consists of 8 questions.
Intervention Type
Other
Intervention Name(s)
mMRC
Intervention Description
It is the scale used to measure the severity of shortness of breath.
Primary Outcome Measure Information:
Title
Small airway dysfunction will be evaluated by performing impulse oscillometry test.
Description
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.
Time Frame
through study completion, an average of 1 year
Title
Small airway dysfunction will be evaluated by thorax computed tomography.
Description
Indirect changes caused by the small airways on the lung parenchyma will be detected by computed tomography (CT).
Time Frame
through study completion, an average of 1 year
Title
Small airway dysfunction will be evaluated by body plethysmography test.
Description
Residual volume (RV) and total lung capacity (TLC) will be measured by body plethysmography test to determine small airway dysfunction.
Time Frame
through study completion, an average of 1 year
Title
Symptoms will be evaluated by Modified Medical Research Council Dyspnea Scale (mMRC).
Description
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.
Time Frame
through study completion, an average of 1 year
Title
The number of moderate and severe exacerbations over a 1 year period will be recorded.
Description
In the COPD group, each participant will be followed for 1 year in terms of recording exacerbations.
Time Frame
through study completion, an average of 1 year
Title
Forced expiratory volume in 1 second (fev1) change will be evaluated by spirometric pulmonary function test.
Description
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.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Fractional Exhaled Nitric Oxide (FENO) test will be used as an indicator of inflammation.
Description
FENO test is indirect measurements of inflammation, as used in clinical practice.
Time Frame
through study completion, an average of 1 year
Title
Complete blood count ( CBC) test will be used as an indicator of inflammation.
Description
Blood eosinophil levels will be recorded.
Time Frame
through study completion, an average of 1 year
Title
Quality of life will be evaluated by COPD Assessment Test (CAT).
Description
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.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sibel Nayci, Prof.Dr.
Organizational Affiliation
Mersin University, Department of Respiratory Diseases
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Demet Polat Yulug, Dr.
Organizational Affiliation
Mersin University, Department of Respiratory Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mersin University Faculty of Medicine, Department of Respiratory Diseases
City
Mersin
State/Province
Yenisehir
ZIP/Postal Code
33070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27852080
Citation
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.
Results Reference
background
PubMed Identifier
26037949
Citation
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.
Results Reference
background

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

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