Association Between Fractional Exhaled Nitric Oxide and Asthma Control

Bronchial Asthma Clinical Trial

— FeNO_AS  

Official title:

Association Between Fractional Exhaled Nitric Oxide and Asthma Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197690
• Other study ID #: 602/2552(EC1)
• Status: Completed
• Phase: N/A
• First received: July 18, 2010
• Last updated: September 17, 2015
• Start date: February 2010
• Est. completion date: December 2010

Study information

• Verified date: September 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• 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 patients that divided into subgroups due to level of asthma control 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. We hypothesized that in uncontrolled or partly controlled group may have high level of fractional exhaled nitric oxide (FeNO) than controlled group.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 60 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

• has 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: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fractional exhaled nitric oxide level		10 minutes (average time), on the day of enrollment	No
Secondary	scores of asthma control test: ACT		5 minutes (average time), on the day of enrollment	No