A Longitudinal Study of Exhaled Nitric Oxide in Children (LENOS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by University of Aberdeen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT00991874
First received: October 7, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

Five percent of children in the UK are prescribed steroid inhalers to control asthma symptoms but there is no test to determine whether the dose of steroids is correct. Too much steroid treatment has potential side effects and too little may lead to asthma attacks. Exhaled nitric oxide (ENO) is a gas present in everyone's breath and may be a useful "meter" for asthma control. In children, ENO can be measured easily and quickly, the results are available immediately to the doctor or nurse and for these reasons ENO is an attractive clinical test.

Pioneering studies have used ENO to help clinicians treat asthmatic adults and children and the results are promising. Breathing tests improved among those where asthma treatment was guided by ENO and asthma symptoms were slightly less frequent. These studies all used a single ENO value to increase or reduce treatment and study authors have suggested there should be a range of ENO values where treatment is neither increased nor reduced; what is not known is what these ENO values may be. Elevated NO is associated with a number of factors other than asthma, including allergy and pollen exposure. What is not known is how factors other than asthma affect ENO measurements over time.

The proposed study will answer two important questions: What values of ENO indicate that steroid treatment should be increased or reduced? And how much does ENO rise and fall normally? The investigators will recruit 200 asthmatic and non-asthmatic children. The investigators will measure ENO on six occasions over a 12-month period. The investigators will measure factors that may affect ENO other than asthma. For the asthmatic children, the investigators will also assess asthma control. The investigators' methodology is based on several years experience with ENO. The investigators' results will allow ENO to be used to monitor asthma.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Longitudinal Study of Exhaled Nitric Oxide in Children

Resource links provided by NLM:


Further study details as provided by University of Aberdeen:

Estimated Enrollment: 200
Study Start Date: August 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children with and without asthma

Criteria

Inclusion Criteria:

  • Child aged 5-10 years

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991874

Sponsors and Collaborators
University of Aberdeen
Investigators
Principal Investigator: Steve Turner, MD University of Aberdeen
  More Information

No publications provided

Responsible Party: Dr Steve Turner - Senior Clinical Lecturer, University of Aberdeen
ClinicalTrials.gov Identifier: NCT00991874     History of Changes
Other Study ID Numbers: 09/S0801/53
Study First Received: October 7, 2009
Last Updated: October 7, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Aberdeen:
Nitric oxide
Asthma
Longitudinal studies
Child

Additional relevant MeSH terms:
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
Gasotransmitters
Protective Agents

ClinicalTrials.gov processed this record on September 18, 2014