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NCT01227070 · ClinicalTrials.gov registry record
Airflow Obstruction and Biomarkers of Airway Inflammation During and Following Acute Exacerbations of Childhood Asthma
A clinical trial, sponsored by Seattle Children's Hospital.
- Completed
- Registry status
- 80
- Enrollment target
NCT01227070: Completed study, sponsored by Seattle Children's Hospital.
NCT01227070 is a clinical trial that has completed, run by Seattle Children's Hospital. The registered enrollment target is 80 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01227070 has completed, sponsored by Seattle Children's Hospital.
- COMPLETED
- Registry status
- 80 participants
- Enrollment target
Study Summary
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: 1. 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. 2. 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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2006-01 |
| Est. Completion | 2010-03 |
What the finished NCT01227070 record still lists
NCT01227070 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01227070 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01227070 about?
NCT01227070 is a clinical study titled "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 w...
What is the current status of trial NCT01227070?
This trial is currently completed. The enrollment target is 80 participants. The study started on 2006-01. Estimated completion is 2010-03.
Who is sponsoring clinical trial NCT01227070?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
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