Airflow Obstruction and Biomarkers of Airway Inflammation During and Following Acute Exacerbations of Childhood Asthma

Asthma Clinical Trial

Official title:

Airflow Obstruction and Biomarkers of Airway Inflammation During and Following Acute Exacerbations of Childhood Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01227070
• Other study ID #: SCH IRB 11798
• Secondary ID: IRUSBUPR0055
• Status: Completed
• Phase: N/A
• First received: October 20, 2010
• Last updated: October 20, 2010
• Start date: January 2006
• Est. completion date: March 2010

Study information

• Verified date: October 2010
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

Asthma Group

1. At least a one-year history of physician diagnosed asthma

2. Enrollment within 48 hours of hospitalization, and prior to hospital discharge, for an acute asthma exacerbation.

3. Age 6 - 18 years.

4. Birth at = 36 weeks gestation.

5. Ability to perform acceptable and reproducible spirometry meeting American Thoracic Society guidelines.

Control Group

1. Age 6 - 18 years.

2. No prior history of asthma.

3. Birth at = 36 weeks gestation.

4. Ability to perform acceptable and reproducible spirometry meeting American Thoracic Society guidelines.

Exclusion Criteria:

Asthma Group

1. History of daily oral steroid use during the month before treatment for the current exacerbation.

2. Use of a leukotriene antagonist.

3. Birth at = 36 weeks gestation.

Control Group

1. History of asthma or reactive airway disease.

2. History of a prior illness with wheezing.

3. History of chronic cough (daily over the month prior to enrollment).

4. History of allergic rhinitis.

5. History of atopic dermatitis.

6. History of food allergies.

7. A URI or episode of sinusitis within 3 weeks of study entry.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1		1 month	No
Secondary	FEF25-75		1 month	No
Secondary	exhaled nitric oxide concentration		1 month	No
Secondary	Breath condensate cysteinyl leukotriene concentration		1 month	No
Secondary	albuterol use		1 month	No
Secondary	school absence		1 month	No