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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03716219
Other study ID # 2012-9253
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 10, 2013
Est. completion date October 10, 2013

Study information

Verified date February 2021
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this research is to determine whether 10-weeks of exercise training can benefit asthmatic children and young adults with a history of exercise-induced bronchoconstriction (EIB). The investigators will also study an exciting newly discovered aspect of gene expression regulation in the white blood cells known as epigenetics: a process that takes place when genomic changes happen as a result of exposure to the environment. This study is based on emerging exciting new data from this and other laboratories demonstrating that (a) white blood cells play an important role in bronchoconstriction in children, (b) gene and cytokine expression in circulating white blood cells are abnormal in asthma and (c) brief exercise may change genomic and inflammatory- profiles of these cells.Physical activity is an essential component of growth and health in children, thus, this research will lead to improved clinical uses of exercise as preventive and adjunctive therapy in the current epidemic of childhood asthma


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date October 10, 2013
Est. primary completion date October 10, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 35 Years
Eligibility Inclusion Criteria: - Good health - Physical activity - No evidence of disease or disability - Diagnosed with persistent asthma (asthma subjects) - BMI<95 percentile Exclusion Criteria: - Use of illegal drugs or alcohol - Very high physical fitness - Pregnancy - More than two asthma attack per week (asthma subjects)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise Training
Physical activity in children and adults with asthma.

Locations

Country Name City State
United States Pediatric Exercise and Genomics Research Center, University of California, Irvine Irvine California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

References & Publications (7)

Baines KJ, Simpson JL, Bowden NA, Scott RJ, Gibson PG. Differential gene expression and cytokine production from neutrophils in asthma phenotypes. Eur Respir J. 2010 Mar;35(3):522-31. doi: 10.1183/09031936.00027409. Epub 2009 Sep 24. — View Citation

Baines KJ, Simpson JL, Scott RJ, Gibson PG. Immune responses of airway neutrophils are impaired in asthma. Exp Lung Res. 2009 Sep;35(7):554-69. — View Citation

Cooper DM, Radom-Aizik S, Schwindt C, Zaldivar F Jr. Dangerous exercise: lessons learned from dysregulated inflammatory responses to physical activity. J Appl Physiol (1985). 2007 Aug;103(2):700-9. Epub 2007 May 10. Review. — View Citation

Dougherty RH, Fahy JV. Acute exacerbations of asthma: epidemiology, biology and the exacerbation-prone phenotype. Clin Exp Allergy. 2009 Feb;39(2):193-202. doi: 10.1111/j.1365-2222.2008.03157.x. Review. — View Citation

Drews AC, Pizzichini MM, Pizzichini E, Pereira MU, Pitrez PM, Jones MH, Sly PD, Stein RT. Neutrophilic airway inflammation is a main feature of induced sputum in nonatopic asthmatic children. Allergy. 2009 Nov;64(11):1597-601. doi: 10.1111/j.1398-9995.2009.02057.x. Epub 2009 Apr 14. — View Citation

Petersen AM, Pedersen BK. The role of IL-6 in mediating the anti-inflammatory effects of exercise. J Physiol Pharmacol. 2006 Nov;57 Suppl 10:43-51. Review. — View Citation

Radom-Aizik S, Zaldivar F Jr, Oliver S, Galassetti P, Cooper DM. Evidence for microRNA involvement in exercise-associated neutrophil gene expression changes. J Appl Physiol (1985). 2010 Jul;109(1):252-61. doi: 10.1152/japplphysiol.01291.2009. Epub 2010 Jan 28. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Gene and microRNA expression will be compared between healthy and asthmatic subjects Monocyte gene expression profiling before and after acute bout of exercise before and after 10-week exercise intervention is gauged using RNA seq in a group of children with asthma and age and sex match healthy controls 12 weeks
Secondary Pro/anti-inflammatory cytokines and markers of oxidative stress will be compared between the groups Absolute values of cytokines, growth hormones, and other biomarkers will be measured by flow cytometry and statistically analyzed. 12 weeks
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