AsthmaNCT04375995
The Prevalence Of Small Airways Dysfunction In Asthma Patients And The Impact On The Asthma Control
A study testing Impulse oscillometry, Spirometric pulmonary function test and Fractional exhaled nitric oxide (FENO) test in people with Asthma and Small Airway Disease, run by Sibel Naycı at 1 site in Turkey (Türkiye).
Trial summary
Asthma, which are one of the most important causes of morbidity and mortality both in the world and in our country, constitute a very serious social and economic burden. An estimated 300 million people suffer from asthma worldwide, which is a major public health problem. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma, 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
- 108 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
- Asthma 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 asthma with spirometry test
- Reading and signing Informed Consent Form
- Participants must be older than 18 years Healthy control group
- To apply to the chest diseases clinic of Mersin University Hospital between October 1, 2019 and April 1, 2020
Show all 10Show fewer
- 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
About this study
Asthma, which are one of the most important causes of morbidity and mortality both in the world and in our country, constitute a very serious social and economic burden. An estimated 300 million people suffer from asthma worldwide, which is a major public health problem. Asthma is complex and heterogeneous chronic airway diseases that require a multifaceted approach. In asthma, small airways represent key regions of airflow obstruction. Although small airway dysfunction 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. Thus, there is an unmet need to assess its role in the control of the disease. Therefore, our primary aim in the study is to determine the frequency of small airway dysfunction measured by impulse oscillometry in Asthma patients. 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 Asthma.
Read the detailed description
This is a prospective cross-sectional interventional design. 73 asthmatic 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 volunteers 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 asthma 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 asthma phenotype.Asthma control test (ACT) will be applied to measure symptom control in patients with asthma. Asthma quality of life scale (AQLQ) will be applied to determine the quality of life in asthmatic patients. All patients will be followed for 1 year to record the number of exacerbations requiring emergency and hospital admissions for asthma. The effect of small airway dysfunction on asthma group, 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
- Asthma, Small Airway Disease
- Being tested
- Impulse oscillometry, Spirometric pulmonary function test, Fractional exhaled nitric oxide (FENO) test, Thorax Computed Tomography, Blood eosinophil level
- Keywords
- Asthma, Small Airway Dysfunction, Impulse oscillometry
- Medical subject headings
- Asthma, 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 test will be applied to all groups.
Spirometric pulmonary function testDiagnostic test
Spirometric pulmonary function test will be applied to all groups.
Fractional exhaled nitric oxide (FENO) testDiagnostic test
FeNO test will be applied to asthma group.
Thorax Computed TomographyDiagnostic test
Thorax Computed Tomography will be taken to the asthma group.
Blood eosinophil levelDiagnostic test
The blood eosinophil level will be evaluated to determine the phenotype in the asthma group.
Asthma control testOther
Asthma control test questions will be applied to the asthma group.
Asthma quality of life scaleOther
Asthma quality of life scale (AQLQ) will be applied to the asthma group.
Chest X RayDiagnostic test
Chest X Ray will be applied to the healthy control group.
| Study group | Role | What they receive |
|---|---|---|
| Asthma group | Other | Impulse oscillometric pulmonary function tests and spirometric pulmonary function test will be performed to all asthmatic patients.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. Asthma control test (ACT) and asthma quality of life scale (AQLQ) will be applied. All patients will be followed for 1 year to record the number of exacerbations requiring emergency and hospital admissions for asthma. 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: Asthma control test; Other: Asthma quality of life scale |
| Healthy control group | 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.
We will used respiratory resistance at 5 and 20 Hz (R5 and R20, respectively) 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
Symptom control will be evaluated by asthma control test.
The asthma control test consists of 5 questions.
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 asthma 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)
Quality of life will be evaluated by Asthma Quality of Life Questionnaire (AQLQ).
Asthma Quality of Life Questionnaire (AQLQ) contains 32 questions.
Measured: through study completion, an average of 1 year
Fractional Exhaled Nitric Oxide (FENO) test will be used as an indicator of inflammation in determining the relationship between airway inflammation and small airway dysfunction.
FENO test is indirect measurements of inflammation, as used in clinical practice.
Measured: through study completion, an average of 1 year
The relationship between blood inflammation cells and small airway dysfunction will be evaluated by complete blood count ( CBC).
Blood eosinophil and neutrophil levels will be recorded.
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.
- First posted6 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 AsthmaStudies 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sibel Naycı
- Sponsor type
- University, hospital or other
- Collaborators
- Mersin University
- Responsible party
- Sponsor-investigator, Sibel Naycı, Mersin University
- Investigators
- Sibel Nayci, Prof.Dr., Study chair, Mersin University, Department of Respiratory DiseasesDemet Polat Yulug, Dr., Principal investigator, Mersin University, Department of Respiratory Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04375995
- Sponsor's protocol ID
- 2019-2-TP3-3539-1
- Status last verified
- May 2020
- First submitted
- 28 Apr 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Postma DS, Brightling C, Baldi S, Van den Berge M, Fabbri LM, Gagnatelli A, Papi A, Van der Molen T, Rabe KF, Siddiqui S, Singh D, Nicolini G, Kraft M; ATLANTIS study group. Exploring the relevance and extent of small airways dysfunction in asthma (ATLANTIS): baseline data from a prospective cohort study. Lancet Respir Med. 2019 May;7(5):402-416. doi: 10.1016/S2213-2600(19)30049-9. Epub 2019 Mar 12.
PubMed 30876830Usmani OS, Singh D, Spinola M, Bizzi A, Barnes PJ. The prevalence of small airways disease in adult asthma: A systematic literature review. Respir Med. 2016 Jul;116:19-27. doi: 10.1016/j.rmed.2016.05.006. Epub 2016 May 7.
PubMed 27296816
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence Of Small Airways Dysfunction In Asthma Patients And The Impact On The Asthma Control
- ClinicalTrials.gov ID
- NCT04375995
- Acronym / sponsor ID
- 2019-2-TP3-3539-1
- Conditions
- Asthma, Small Airway Disease
- Keywords
- Asthma, Small Airway Dysfunction, Impulse oscillometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 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
- 6 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.
Asthma, which are one of the most important causes of morbidity and mortality both in the world and in our country, constitute a very serious social and economic burden. An estimated 300 million people suffer from asthma worldwide, which is a major public health problem. Asthma is complex and heterogeneous chronic airway diseases that require a multifaceted approach. In asthma, small airways represent key regions of airflow obstruction. Although small airway dysfunction 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. Thus, there is an unmet need to assess its role in the control of the disease. Therefore, our primary aim in the study is to determine the frequency of small airway dysfunction measured by impulse oscillometry in Asthma patients. 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 Asthma.
Detailed description
This is a prospective cross-sectional interventional design. 73 asthmatic 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 volunteers 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 asthma 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 asthma phenotype.Asthma control test (ACT) will be applied to measure symptom control in patients with asthma. Asthma quality of life scale (AQLQ) will be applied to determine the quality of life in asthmatic patients. All patients will be followed for 1 year to record the number of exacerbations requiring emergency and hospital admissions for asthma. The effect of small airway dysfunction on asthma group, 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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma 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: Asthma control test, Other: Asthma quality of life scaleImpulse oscillometric pulmonary function tests and spirometric pulmonary function test will be performed to all asthmatic patients.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. Asthma control test (ACT) and asthma quality of life scale (AQLQ) will be applied. All patients will be followed for 1 year to record the number of exacerbations requiring emergency and hospital admissions for asthma. |
| Healthy control group | 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 (10 listed)
- Asthma 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 asthma with spirometry test
- Reading and signing Informed Consent Form
- Participants must be older than 18 years Healthy control group
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 test will be applied to all groups. | Diagnostic test | Asthma group, Healthy control group |
| Spirometric pulmonary function testSpirometric pulmonary function test will be applied to all groups. | Diagnostic test | Asthma group, Healthy control group |
| Fractional exhaled nitric oxide (FENO) testFeNO test will be applied to asthma group. | Diagnostic test | Asthma group |
| Thorax Computed TomographyThorax Computed Tomography will be taken to the asthma group. | Diagnostic test | Asthma group |
| Blood eosinophil levelThe blood eosinophil level will be evaluated to determine the phenotype in the asthma group. | Diagnostic test | Asthma group |
| Asthma control testAsthma control test questions will be applied to the asthma group. | Other | Asthma group |
| Asthma quality of life scaleAsthma quality of life scale (AQLQ) will be applied to the asthma group. | Other | Asthma group |
| Chest X RayChest X Ray will be applied to the healthy control group. | Diagnostic test | Healthy control group |
Primary outcome
Small airway dysfunction will be evaluated by performing impulse oscillometry test.
Time frame: through study completion, an average of 1 year
We will used respiratory resistance at 5 and 20 Hz (R5 and R20, respectively) 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.
Symptom control will be evaluated by asthma control test.
Time frame: through study completion, an average of 1 year
The asthma control test consists of 5 questions.
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 asthma 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
Quality of life will be evaluated by Asthma Quality of Life Questionnaire (AQLQ).
Time frame: through study completion, an average of 1 year
Fractional Exhaled Nitric Oxide (FENO) test will be used as an indicator of inflammation in determining the relationship between airway inflammation and small airway dysfunction.
Time frame: through study completion, an average of 1 year
The relationship between blood inflammation cells and small airway dysfunction will be evaluated by complete blood count ( CBC).
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 6 May 2020.
- Background: PubMed 30876830Postma DS, Brightling C, Baldi S, Van den Berge M, Fabbri LM, Gagnatelli A, Papi A, Van der Molen T, Rabe KF, Siddiqui S, Singh D, Nicolini G, Kraft M; ATLANTIS study group. Exploring the relevance and extent of small airways dysfunction in asthma (ATLANTIS): baseline data from a prospective cohort study. Lancet Respir Med. 2019 May;7(5):402-416. doi: 10.1016/S2213-2600(19)30049-9. Epub 2019 Mar 12.
- Background: PubMed 27296816Usmani OS, Singh D, Spinola M, Bizzi A, Barnes PJ. The prevalence of small airways disease in adult asthma: A systematic literature review. Respir Med. 2016 Jul;116:19-27. doi: 10.1016/j.rmed.2016.05.006. Epub 2016 May 7.
- Individual participant dataSharing planned: No
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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?
A study testing Impulse oscillometry, Spirometric pulmonary function test and Fractional exhaled nitric oxide (FENO) test in people with Asthma and Small Airway Disease, run by Sibel Naycı at 1 site in Turkey (Türkiye).
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 10 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 6 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 NCT04375995, 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 6 May 2020.