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

NCT04375995 | Unknown DMC

• 1 other identifier: 2019-2-TP3-3539-1
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Small Airway Disease

Keywords

Asthma; Small Airway Dysfunction; Impulse oscillometry

Outcome Measures

Primary Outcomes (6)

• 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.

  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).

  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.

  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.

  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.

  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.

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Quality of life will be evaluated by Asthma Quality of Life Questionnaire (AQLQ).

  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.

  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).

  through study completion, an average of 1 year

Study Arms (2)

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.

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.

Diagnostic Test: Impulse oscillometry; Diagnostic Test: Spirometric pulmonary function test; Diagnostic Test: Chest X Ray

Interventions

Impulse oscillometry DIAGNOSTIC_TEST

Impulse oscillometry test will be applied to all groups.

Asthma group; Healthy control group

Spirometric pulmonary function test DIAGNOSTIC_TEST

Spirometric pulmonary function test will be applied to all groups.

Asthma group; Healthy control group

Fractional exhaled nitric oxide (FENO) test DIAGNOSTIC_TEST

FeNO test will be applied to asthma group.

Asthma group

Thorax Computed Tomography DIAGNOSTIC_TEST

Thorax Computed Tomography will be taken to the asthma group.

Asthma group

Blood eosinophil level DIAGNOSTIC_TEST

The blood eosinophil level will be evaluated to determine the phenotype in the asthma group.

Asthma group

Asthma control test OTHER

Asthma control test questions will be applied to the asthma group.

Asthma group

Asthma quality of life scale OTHER

Asthma quality of life scale (AQLQ) will be applied to the asthma group.

Asthma group

Chest X Ray DIAGNOSTIC_TEST

Chest X Ray will be applied to the healthy control group.

Healthy control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sibel Naycı: lead
• Mersin University: collaborator

Study Sites (1)

Mersin University Faculty of Medicine, Department of Respiratory Diseases

Mersin, Yenisehir, 33070, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 30876830 BACKGROUND

• 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.

  PMID: 27296816 BACKGROUND

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Interventions

Fractional Exhaled Nitric Oxide Testing; Diagnostic Imaging

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Breath Tests; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Sibel Nayci, Prof.Dr.

  Mersin University, Department of Respiratory Diseases

  STUDY CHAIR

• Demet Polat Yulug, Dr.

  Mersin University, Department of Respiratory Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 6, 2020
• Study Start: October 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: April 1, 2021
• Last Updated: May 6, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)