NCT04375995

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Sibel Naycı · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Asthma
• Small Airway Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Impulse oscillometry	Impulse oscillometry test will be applied to all groups.
DIAGNOSTIC_TEST	Spirometric pulmonary function test	Spirometric pulmonary function test will be applied to all groups.
DIAGNOSTIC_TEST	Fractional exhaled nitric oxide (FENO) test	FeNO test will be applied to asthma group.
DIAGNOSTIC_TEST	Thorax Computed Tomography	Thorax Computed Tomography will be taken to the asthma group.
DIAGNOSTIC_TEST	Blood eosinophil level	The blood eosinophil level will be evaluated to determine the phenotype in the asthma group.
OTHER	Asthma control test	Asthma control test questions will be applied to the asthma group.
OTHER	Asthma quality of life scale	Asthma quality of life scale (AQLQ) will be applied to the asthma group.
DIAGNOSTIC_TEST	Chest X Ray	Chest X Ray will be applied to the healthy control group.

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-09-01
• Completion: 2021-04-01
• First posted: 2020-05-06
• Last updated: 2020-05-06

Locations

1 site across 1 country: Turkey (Türkiye)