Association Between Fractional Exhaled Nitric Oxide and Asthma Control (FeNO_AS)

September 17, 2015 updated by: Nualanong Visitsunthorn, Mahidol University
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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

62

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
      • Bangkok, Thailand
        • Siriraj Hospital

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

7 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

atopic asthmatic patients in Department of Pediatrics, Siriraj hospital (tertiary care)

Description

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 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
Time Frame
fractional exhaled nitric oxide level
Time Frame: 10 minutes (average time), on the day of enrollment
10 minutes (average time), on the day of enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
scores of asthma control test: ACT
Time Frame: 5 minutes (average time), on the day of enrollment
5 minutes (average time), on the day of enrollment

Collaborators and Investigators

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

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Professor Nualanong Visitsunthorn, MD, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University

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

February 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

July 18, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (Estimate)

September 9, 2010

Study Record Updates

Last Update Posted (Estimate)

September 18, 2015

Last Update Submitted That Met QC Criteria

September 17, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 602/2552(EC1)

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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