The Correlations of FeNO, Blood Eosinophils and Lung Function in Well-controlled Asthma

In Asthma, the levels of exhaled FeNO is correlated to sputum eosinophils particularly in the patient with poor controlled asthma or severe asthma. Moreover, the blood eosinophils had been studied that are also correlated to sputum eosinophils in similar patients group. According to well controlled asthma, althoug hin clinical practice guidelines recommend that the stepping down therapy should be considered to those patients due to the risks or costs of daily treatment, there is previous study has been shown that the airway hyperresponsiveness and sputum eosinophilia are predictors of loss of control during dose reduction. And, these tests are not readily available in primary care. However, there is limit number of clinical study to study the correlation of biologic markers among the patients with well controlled level before the stepping down management.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Narongwit Nakwan

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

This is a single prospective trial. Enrollment will continue until 50 patients with well controlled asthma have been entered into this trial and have completed blood tests and spirometry. In this trial, the following parameters are to be evaluated:

Blood eosinophils (absolute and relative) FeNO Pulmonary lung function test: FEV1, FVC, PF, MMEF 25-75%, % reversibility

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with diagnosis of asthma (according to the guidelines)
Age >15 years
Patients with treating with step 3 base on GINA by only low dose ICS/LABA without oral bronchodilator with being in well controlled asthma based on ACT (> = 23) and ACQ-7 (<0.75) for at least 12 weeks
Ability to provide informed consent and do spirometry following ATS guideline

Exclusion criteria

Pulmonary infection or exacerbation within the last 12 weeks before enrolment
Patients with preceding taken systemic steroid 12 week before enrolment
Additional pulmonary diseases (pneumonia, lung cancer, tuberculosis, interstitial lung disease)
A history of smoking >= 10 pack-year

Treatment and study plan

Patients with well controlled asthma

Diagnostic Test

Patients with well controlled asthma

The following parameters are to be evaluated:

Blood eosinophils FeNO Findings on lung function test

Primary outcomes

Assessment of eosinophilic inflammation by correlating blood eosinophil count, FeNO measurement and lung function test

Time frame: 3 months

Correlation of FeNO, blood eosinophils, lung function test in patients with well controlled asthma before stepping down medication

Sponsors and collaborators

Lead sponsor

Hat Yai Medical Education Center

Other

Registry information

Official study title

The Correlations of FeNO, Blood Eosinophils and Lung Function in Well-controlled Asthma Based on Asthma Controlled Questionnaires

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jul 1, 2020
Registry last updated: Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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