The Prevalence Of Small Airways Dysfunction In Asthma Patients And The Impact On The Asthma Control

Sibel Naycı

Status

Unknown

Conditions

Asthma

Small Airway Disease

Treatments

Diagnostic Test: Thorax Computed Tomography

Diagnostic Test: Impulse oscillometry

Diagnostic Test: Chest X Ray

Other: Asthma control test

Other: Asthma quality of life scale

Diagnostic Test: Fractional exhaled nitric oxide (FENO) test

Diagnostic Test: Spirometric pulmonary function test

Diagnostic Test: Blood eosinophil level

Study type

Interventional

Funder types

Other

Identifiers

NCT04375995

2019-2-TP3-3539-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

108 participants in 2 patient groups

Asthma group

Other group

Description:

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.

Treatment: