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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04454385
• Other study ID #: 56/2563
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: October 31, 2020

Study information

• Verified date: June 2020
• Source: Hat Yai Medical Education Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Diagnostic Test:
• Patients with well controlled asthma
Patients with well controlled asthma The following parameters are to be evaluated: Blood eosinophils FeNO Findings on lung function test

Locations

Country	Name	City	State
Thailand	Narongwit Nakwan	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Hat Yai Medical Education Center

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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