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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sibel Naycı

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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