The Prevalence Of Small Airways Dysfunction In Asthma Patients And The Impact On The Asthma Control
NCT ID: NCT04375995
Last Updated: 2020-05-06
Study Results
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Basic Information
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UNKNOWN
NA
108 participants
INTERVENTIONAL
2019-10-01
2021-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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Asthma group
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.
Impulse oscillometry
Impulse oscillometry test will be applied to all groups.
Spirometric pulmonary function test
Spirometric pulmonary function test will be applied to all groups.
Fractional exhaled nitric oxide (FENO) test
FeNO test will be applied to asthma group.
Thorax Computed Tomography
Thorax Computed Tomography will be taken to the asthma group.
Blood eosinophil level
The blood eosinophil level will be evaluated to determine the phenotype in the asthma group.
Asthma control test
Asthma control test questions will be applied to the asthma group.
Asthma quality of life scale
Asthma quality of life scale (AQLQ) will be applied to the asthma group.
Healthy control group
Impulse oscillometric pulmonary function test, spirometric pulmonary function test and chest x ray will be performed.
Impulse oscillometry
Impulse oscillometry test will be applied to all groups.
Spirometric pulmonary function test
Spirometric pulmonary function test will be applied to all groups.
Chest X Ray
Chest X Ray will be applied to the healthy control group.
Interventions
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Impulse oscillometry
Impulse oscillometry test will be applied to all groups.
Spirometric pulmonary function test
Spirometric pulmonary function test will be applied to all groups.
Fractional exhaled nitric oxide (FENO) test
FeNO test will be applied to asthma group.
Thorax Computed Tomography
Thorax Computed Tomography will be taken to the asthma group.
Blood eosinophil level
The blood eosinophil level will be evaluated to determine the phenotype in the asthma group.
Asthma control test
Asthma control test questions will be applied to the asthma group.
Asthma quality of life scale
Asthma quality of life scale (AQLQ) will be applied to the asthma group.
Chest X Ray
Chest X Ray will be applied to the healthy control group.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Mersin University
OTHER
Sibel Naycı
OTHER
Responsible Party
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Sibel Naycı
Prof. Dr.
Principal Investigators
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Sibel Nayci, Prof.Dr.
Role: STUDY_CHAIR
Mersin University, Department of Respiratory Diseases
Demet Polat Yulug, Dr.
Role: PRINCIPAL_INVESTIGATOR
Mersin University, Department of Respiratory Diseases
Locations
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Mersin University Faculty of Medicine, Department of Respiratory Diseases
Mersin, Yenisehir, Turkey (Türkiye)
Countries
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References
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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.
Usmani 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.
Other Identifiers
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2019-2-TP3-3539-1
Identifier Type: -
Identifier Source: org_study_id
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