Airflow Obstruction and Biomarkers of Airway Inflammation During and Following Acute Exacerbations of Childhood Asthma
This study is a longitudinal single-center pilot study designed to describe changes in lung function and levels of noninvasive biomarkers of airway inflammation in children ages 6-18 years over two months following hospitalization for an acute exacerbation of asthma. Forty children ages 6-18 years with asthma who are admitted to Children's Hospital and Regional Medical Center (GCRC) for an asthma exacerbation will be enrolled and complete an initial study visit prior to hospital discharge. Children with asthma will be recruited from the inpatient medical unit. During their initial visit subjects will undergo a clinical assessment and perform spirometry to measure lung function. In addition, exhaled nitric oxide (eNO) concentration will be measured and a sample of exhaled breath condensate (eBC) will be collected during 20 minutes of tidal breathing. Breath condensate will be analyzed to determine the concentration of cysteinyl leukotrienes (CysLT), an important mediator of airway inflammation in asthma. Subjects with asthma will return to the GCRC pediatric satellite at Seattle Children's Hospital for follow-up study visits at 1 week, 2 weeks, and 4 weeks following hospital discharge. During follow-up visits subjects will complete a questionnaire regarding symptoms and medication use since the most recent study visit, will perform spirometry, and have eNO concentration measured and breath condensate collected for CysLT analysis.
The aims of this observational study are to:
- Assess the association of levels of exhaled nitric oxide and cysteinyl leukotrienes in breath condensate with measures of airflow obstruction (FEV1) and asthma symptoms during, and at one, two, and four weeks following hospital discharge for asthma exacerbation.
- Compare levels of exhaled nitric oxide and cysteinyl leukotrienes in breath condensate from children ages 6-18 years hospitalized for status asthmaticus to levels from age-matched healthy control subjects without asthma.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Airflow Obstruction and Biomarkers of Airway Inflammation During and Following Acute Exacerbations of Childhood Asthma|
- FEV1 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- FEF25-75 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- exhaled nitric oxide concentration [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Breath condensate cysteinyl leukotriene concentration [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- albuterol use [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- school absence [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Exhaled breath condensate
|Study Start Date:||January 2006|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227070
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98115|
|Principal Investigator:||Jason S Debley, MD, MPH||Seattle Children's Hospital|