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

May 1, 2020 updated by: Sibel Naycı
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yenisehir
      • Mersin, Yenisehir, Turkey, 33070
        • Mersin University Faculty of Medicine, Department of Respiratory Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
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.
OTHER: Healthy control group
Impulse oscillometric pulmonary function test, spirometric pulmonary function test and chest x ray will be performed.
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: Chest X Ray
Chest X Ray will be applied to the healthy control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Small airway dysfunction will be evaluated by thorax computed tomography.
Time Frame: through study completion, an average of 1 year
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.
Time Frame: through study completion, an average of 1 year
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
Forced expiratory volume in 1 second (fev1) change will be evaluated by spirometric pulmonary function test.
Time Frame: through study completion, an average of 1 year
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
Small airway dysfunction will be evaluated by performing impulse oscillometry test.
Time Frame: through study completion, an average of 1 year
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
Symptom control will be evaluated by asthma control test.
Time Frame: through study completion, an average of 1 year
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.
Time Frame: through study completion, an average of 1 year
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life will be evaluated by Asthma Quality of Life Questionnaire (AQLQ).
Time Frame: through study completion, an average of 1 year
Asthma Quality of Life Questionnaire (AQLQ) contains 32 questions.
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.
Time Frame: through study completion, an average of 1 year
FENO test is indirect measurements of inflammation, as used in clinical practice.
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).
Time Frame: through study completion, an average of 1 year
Blood eosinophil and neutrophil levels will be recorded.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sibel Naycı

Collaborators

Mersin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2019

Primary Completion (ANTICIPATED)

September 1, 2020

Study Completion (ANTICIPATED)

April 1, 2021

Study Registration Dates

First Submitted

April 28, 2020

First Submitted That Met QC Criteria

May 1, 2020

First Posted (ACTUAL)

May 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2020

Last Update Submitted That Met QC Criteria

May 1, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-2-TP3-3539-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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