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

January 14, 2021 updated by: Narongwit Nakwan, Hat Yai Medical Education Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

84

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

  • Thailand
    • Songkhla
      • Hat Yai, Songkhla, Thailand, 90110
        • Narongwit Nakwan

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

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

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

Sponsor

Hat Yai Medical Education Center

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)

August 1, 2020

Primary Completion (Actual)

October 31, 2020

Study Completion (Actual)

October 31, 2020

Study Registration Dates

First Submitted

June 28, 2020

First Submitted That Met QC Criteria

June 28, 2020

First Posted (Actual)

July 1, 2020

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 56/2563

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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