COPDNCT04384133

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

A study testing Impulse oscillometry, Spirometric pulmonary function test and Fractional exhaled nitric oxide (FENO) test in people with COPD and Small Airway Disease, run by Sibel Naycı at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: COPD, Small Airway Disease
What is being tested?: Impulse oscillometry, Spirometric pulmonary function test and Fractional exhaled nitric oxide (FENO) test
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 170 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Oct 2019to 1 Apr 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Show all 17Show fewer

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

Who cannot join

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

Show all 9Show fewer

Participants who with respiratory muscle disease
Participants who with active pulmonary tuberculosis
Participants who can not perform respiratory function tests

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

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

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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
Being tested: Impulse oscillometry, Spirometric pulmonary function test, Fractional exhaled nitric oxide (FENO) test, Thorax Computed Tomography, Chest X Ray
Keywords: COPD, Small Airway Dysfunction, Impulse oscillometry
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Impulse oscillometryDiagnostic test
Impulse oscillometry is a pulmonary function test. During the test, the participant is told to breathe normally.
Spirometric pulmonary function testDiagnostic test
In the spirometric pulmonary function test, the participant is asked to perform respiratory maneuvers such as breathing deeply.
Fractional exhaled nitric oxide (FENO) testDiagnostic test
In the FENO test, the participant is asked to perform respiratory maneuvers such as breathing deeply.
Thorax Computed TomographyDiagnostic test
Computed tomography is a radiological examination.
Chest X RayDiagnostic test
Chest X ray is a radiological examination.
Blood eosinophil levelDiagnostic test
A tube of blood will be drawn from the participant.
CATOther
It consists of 8 questions.
mMRCOther
It is the scale used to measure the severity of shortness of breath.

Study groups in NCT04384133
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Impulse oscillometry; Diagnostic Test: Spirometric pulmonary function test; Diagnostic Test: Chest X Ray

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
FENO test is indirect measurements of inflammation, as used in clinical practice.
Measured: through study completion, an average of 1 year
Complete blood count ( CBC) test will be used as an indicator of inflammation.
Blood eosinophil levels will be recorded.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20191 Apr 2021

First posted12 May 2020
Study start1 Oct 2019
Primary completion1 Sep 2020 (estimated)
Study completion1 Apr 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for COPDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04384133
Sponsor's protocol ID: 2019-2-TP3-3539-2
Status last verified: May 2020
First submitted: 6 May 2020
Last updated: 12 May 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 27852080
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.
PubMed 26037949

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Prevalence of Small Airways Dysfunction In COPD Patients and The Impact on COPD Control
ClinicalTrials.gov ID: NCT04384133
Acronym / sponsor ID: 2019-2-TP3-3539-2
Conditions: COPD, Small Airway Disease
Keywords: COPD, Small Airway Dysfunction, Impulse oscillometry
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 170 participants (actual)
Lead sponsor: Sibel NaycıUniversity, hospital or other
Collaborators: Mersin University
Study start: 1 Oct 2019 (actual)
Primary completion: 1 Sep 2020 (estimated)
Study completion: 1 Apr 2021 (estimated)
First posted: 12 May 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
COPD group	Other	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: mMRCImpulse 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.
Healthy control group with a history of smoking	Other	Diagnostic Test: Impulse oscillometry, Diagnostic Test: Spirometric pulmonary function test, Diagnostic Test: Chest X RayImpulse oscillometric pulmonary function test, spirometric pulmonary function test and chest x ray will be performed.
Healthy control group with no smoking history	Other	Diagnostic Test: Impulse oscillometry, Diagnostic Test: Spirometric pulmonary function test, Diagnostic Test: Chest X RayImpulse oscillometric pulmonary function test, spirometric pulmonary function test and chest x ray will be performed.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Impulse oscillometryImpulse oscillometry is a pulmonary function test. During the test, the participant is told to breathe normally.	Diagnostic test	COPD group, Healthy control group with a history of smoking, Healthy control group with no smoking history
Spirometric pulmonary function testIn the spirometric pulmonary function test, the participant is asked to perform respiratory maneuvers such as breathing deeply.	Diagnostic test	COPD group, Healthy control group with a history of smoking, Healthy control group with no smoking history
Fractional exhaled nitric oxide (FENO) testIn the FENO test, the participant is asked to perform respiratory maneuvers such as breathing deeply.	Diagnostic test	COPD group
Thorax Computed TomographyComputed tomography is a radiological examination.	Diagnostic test	COPD group
Chest X RayChest X ray is a radiological examination.	Diagnostic test	Healthy control group with a history of smoking, Healthy control group with no smoking history
Blood eosinophil levelA tube of blood will be drawn from the participant.	Diagnostic test	COPD group
CATIt consists of 8 questions.	Other	COPD group
mMRCIt is the scale used to measure the severity of shortness of breath.	Other	COPD group

Primary outcome

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.
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).
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.
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.
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.
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.

3 secondary outcomes

Fractional Exhaled Nitric Oxide (FENO) test will be used as an indicator of inflammation.
Time frame: 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
Quality of life will be evaluated by COPD Assessment Test (CAT).
Time frame: through study completion, an average of 1 year

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
Background: PubMed 27852080Crisafulli 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.
Background: PubMed 26037949Bonini 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.
Individual participant dataSharing planned: No

Related trials for COPD

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sibel Nayci, Prof.Dr. study chair

Mersin University, Department of Respiratory Diseases

Demet Polat Yulug, Dr. principal investigator

Mersin University, Department of Respiratory Diseases

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Small airway dysfunction will be evaluated by performing impulse oscillometry test. (time frame: through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04384133, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.