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

NCT ID: NCT01227070

Last Updated: 2010-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Asthmatic

No interventions assigned to this group

Healthy Control

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seattle Chidlren's Hospital

Principal Investigators

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Jason S Debley, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

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Seattle Children's Hospital

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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IRUSBUPR0055

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SCH IRB 11798

Identifier Type: -

Identifier Source: org_study_id