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

NCT ID: NCT04375995

Last Updated: 2020-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Small Airway Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

Impulse oscillometry

Intervention Type DIAGNOSTIC_TEST

Impulse oscillometry test will be applied to all groups.

Spirometric pulmonary function test

Intervention Type DIAGNOSTIC_TEST

Spirometric pulmonary function test will be applied to all groups.

Fractional exhaled nitric oxide (FENO) test

Intervention Type DIAGNOSTIC_TEST

FeNO test will be applied to asthma group.

Thorax Computed Tomography

Intervention Type DIAGNOSTIC_TEST

Thorax Computed Tomography will be taken to the asthma group.

Blood eosinophil level

Intervention Type DIAGNOSTIC_TEST

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

Asthma control test

Intervention Type OTHER

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

Asthma quality of life scale

Intervention Type OTHER

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

Healthy control group

Impulse oscillometric pulmonary function test, spirometric pulmonary function test and chest x ray will be performed.

Group Type OTHER

Impulse oscillometry

Intervention Type DIAGNOSTIC_TEST

Impulse oscillometry test will be applied to all groups.

Spirometric pulmonary function test

Intervention Type DIAGNOSTIC_TEST

Spirometric pulmonary function test will be applied to all groups.

Chest X Ray

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Impulse oscillometry

Impulse oscillometry test will be applied to all groups.

Intervention Type DIAGNOSTIC_TEST

Spirometric pulmonary function test

Spirometric pulmonary function test will be applied to all groups.

Intervention Type DIAGNOSTIC_TEST

Fractional exhaled nitric oxide (FENO) test

FeNO test will be applied to asthma group.

Intervention Type DIAGNOSTIC_TEST

Thorax Computed Tomography

Thorax Computed Tomography will be taken to the asthma group.

Intervention Type DIAGNOSTIC_TEST

Blood eosinophil level

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

Intervention Type DIAGNOSTIC_TEST

Asthma control test

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

Intervention Type OTHER

Asthma quality of life scale

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

Intervention Type OTHER

Chest X Ray

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mersin University

OTHER

Sponsor Role collaborator

Sibel Naycı

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sibel Naycı

Prof. Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sibel Nayci, Prof.Dr.

Role: STUDY_CHAIR

Mersin University, Department of Respiratory Diseases

Demet Polat Yulug, Dr.

Role: PRINCIPAL_INVESTIGATOR

Mersin University, Department of Respiratory Diseases

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Mersin University Faculty of Medicine, Department of Respiratory Diseases

Mersin, Yenisehir, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30876830 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27296816 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-2-TP3-3539-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Virtual Care In Pediatric Asthma
NCT05500287 COMPLETED NA