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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · AstraZeneca
observational
80
1 country
1
Study Start
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2010
Actual (reported)Study Completion
March 2010
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2010
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
March 2010
Actual (reported)March 2010
Actual (reported)October 20, 2010
Actual (reported)October 22, 2010
Actual (reported)FEV1
1 month
FEF25-75
1 month
exhaled nitric oxide concentration
1 month
Breath condensate cysteinyl leukotriene concentration
1 month
albuterol use
1 month
school absence
1 month
children ages 6-18 years hospitalized for an asthmat exacerbation, similar aged healthy control children
Seattle Children's Hospital
Seattle, Washington, 98115, United States
Exhaled breath condensate
Jason S Debley, MD, MPH
Seattle Children's Hospital
80 participants (actual enrollment reported by the registry).
First Submitted
October 20, 2010
First Posted
October 22, 2010
Study Start
January 2006
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
March 2010
Actual (reported)Study Completion
March 2010
Actual (reported)Last Updated
October 22, 2010
Record last verified: 2010-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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