A Longitudinal Study of Exhaled Nitric Oxide in Children (LENOS)
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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 |
Children with and without asthma
Inclusion Criteria:
- Child aged 5-10 years
Exclusion Criteria:
- None
Contacts and Locations
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:
|
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 21, 2013