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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Mahidol University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT01197690
First received: July 18, 2010
Last updated: September 7, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition
Bronchial Asthma
Nitric Oxide

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Association Between Fractional Exhaled Nitric Oxide and Asthma Control

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • fractional exhaled nitric oxide level [ Time Frame: 10 minutes (average time), on the day of enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • scores of asthma control test: ACT [ Time Frame: 5 minutes (average time), on the day of enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 62
Study Start Date: February 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   7 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197690

Contacts
Contact: Professor Nualanong Visitsunthorn, MD 662-419-7000 ext 5941 sinvs@mahidol.ac.th
Contact: Associate professor Kittipong Maneechotesuwan, MD 662-419-7000 ext 9642 sikmn@mahidol.ac.th

Locations
Thailand
Siriraj Hospital Recruiting
Bangkok, Thailand
Contact: Professor Nualanong Visitsunthorn, MD     662-419-7000 ext 5941     sinvs@mahidol.ac.th    
Contact: Associate professor Kittipong Maneechotesuwan, MD     662-419-7000 ext 9642     sikmn@mahidol.ac.th    
Principal Investigator: Professor Nualanong Visitsunthorn, MD            
Sub-Investigator: Associate professor Kittipong Maneechotesuwan, MD            
Sub-Investigator: Professor Pakit Vichyanond, MD            
Sub-Investigator: Associate Professor Orathai Piboonpocanun, MD            
Sub-Investigator: Punchama Pacharn, MD            
Sub-Investigator: Parawee Prottasan, MD            
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Professor Nualanong Visitsunthorn, MD Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
  More Information

No publications provided

Responsible Party: Professor Nualanong Visitsunthorn, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT01197690     History of Changes
Other Study ID Numbers: 602/2552(EC1)
Study First Received: July 18, 2010
Last Updated: September 7, 2010
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Bronchial asthma
level of control of asthma
fractional exhaled nitric oxide (FeNO)
asthma control test (ACT)

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013