Clinical trial NCT04375995: The Prevalence Of Small Airways Dysfunction In Asthma Patients And The Impact On The Asthma Control
Official title: The Prevalence Of Small Airways Dysfunction In Asthma Patients And The Impact On The Asthma Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Small Airway Disease
Keywords: Asthma
Small Airway Dysfunction
Impulse oscillometry
Lead sponsor: Mersin University
Sponsor class: OTHER
Collaborators: name: Mersin University
First posted: 2020-05-06
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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
* 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

Primary outcomes:
measure: Small airway dysfunction will be evaluated by performing impulse oscillometry test.
timeFrame: through study completion, an average of 1 year
measure: Small airway dysfunction will be evaluated by thorax computed tomography.
timeFrame: through study completion, an average of 1 year
measure: Small airway dysfunction will be evaluated by body plethysmography test.
timeFrame: through study completion, an average of 1 year
measure: Symptom control will be evaluated by asthma control test.
timeFrame: through study completion, an average of 1 year
measure: The number of moderate and severe exacerbations over a 1 year period will be recorded.
timeFrame: through study completion, an average of 1 year
measure: Forced expiratory volume in 1 second (fev1) change will be evaluated by spirometric pulmonary function test.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Quality of life will be evaluated by Asthma Quality of Life Questionnaire (AQLQ).
timeFrame: through study completion, an average of 1 year
measure: 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.
timeFrame: through study completion, an average of 1 year
measure: The relationship between blood inflammation cells and small airway dysfunction will be evaluated by complete blood count ( CBC).
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Mersin
country: Turkey
facility: Mersin University Faculty of Medicine, Department of Respiratory Diseases
state: Yenisehir
Study officials:
affiliation: Mersin University, Department of Respiratory Diseases
name: Sibel Nayci, Prof.Dr.
role: STUDY_CHAIR
affiliation: Mersin University, Department of Respiratory Diseases
name: Demet Polat Yulug, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.