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

NCT04454385 | Completed

• 1 other identifier: 56/2563
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

FeNO; Blood eosinophil; Pulmonary function test; Well controlled asthma

Outcome Measures

Primary Outcomes (1)

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

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

  3 months

Interventions

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

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with well controlled asthma treating with step 3 base on GINA by only low dose ICS/LABA based on ACT (\> = 23) and ACQ-7 (\<0.75) for at least 12 weeks

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hat Yai Medical Education Center: lead

Study Sites (1)

Narongwit Nakwan

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood for CBC analysis

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.prof Narongwit Nakwan

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 1, 2020
• Study Start: August 1, 2020
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: January 15, 2021

Record last verified: 2020-06

Locations

TH (1)