Correlation Between Fractional Exhaled Nitric Oxide (FeNO) Levels and Asthma Exacerbation

Bronchial Asthma Clinical Trial

Official title:

Correlation Between Fractional Exhaled Nitric Oxide (FeNO) Levels and Asthma Exacerbation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561351
• Other study ID #: Si237/2013
• Status: Completed
• Phase: N/A
• First received: September 16, 2015
• Last updated: May 2, 2016
• Start date: September 2013
• Est. completion date: September 2015

Study information

• Verified date: May 2016
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine mean or median of fractional exhaled nitric oxide (FeNO) in Thai atopic asthmatic children that divided into subgroups due to asthma exacerbation according to the global initiative for asthma guideline.

Description:

From many previous studies, fractional exhaled nitric oxide (FeNO) has many benefits such as non-invasive, easily to perform, less time consume, has direct association with severity of inflammation of bronchial trees and sputum eosinophils, has benefit for diagnosis and monitoring the treatment in asthmatic patients.

In Thailand, this field of study is less extend, especially in children population. The investigators hypothesized that patients with asthma exacerbation may have high level of fractional exhaled nitric oxide (FeNO) than non exacerbation group.

It is therefore desirable to examine the association between fractional exhaled nitric oxide (FeNO) and asthma exacerbation among atopic asthmatic Thai children and will be the main objective of this research.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 20 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of atopic bronchial asthma follow up in clinic of allergy and clinical immunology, Siriraj hospital

Exclusion Criteria:

• smoker or past history of smoking

• chronic disease eg. HIV infection, pulmonary hypertension, systemic lupus erythematosus, liver cirrhosis, gastroesophageal reflux, COPD, bronchiectasis

• drink ethanol within 48 hours before enrollment

• history of upper or lower respiratory tract infection within 6 weeks before enrollment drink caffeine within day before enrollment during pregnancy history of systemic steroid use within 8 weeks before enrollment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Other:
• FeNO measurement
FeNO was performed repeatedly every 3 months in every cases. exacerbations were recorded each visit

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of asthma exacerbation in the studied cases with different FeNO levels	Occurrence of asthma exacerbation in 1 year after the study	1 year	Yes