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NCT Number: NCT01227070

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:

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seattle Children's Hospital

Seattle, Washington, 98115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Asthma Group

  • At least a one-year history of physician diagnosed asthma
  • Enrollment within 48 hours of hospitalization, and prior to hospital discharge, for an acute asthma exacerbation.
  • Age 6 - 18 years.
  • Birth at ≥ 36 weeks gestation.
  • Ability to perform acceptable and reproducible spirometry meeting American Thoracic Society guidelines.

Control Group

  • Age 6 - 18 years.
  • No prior history of asthma.
  • Birth at ≥ 36 weeks gestation.
  • Ability to perform acceptable and reproducible spirometry meeting American Thoracic Society guidelines.

Exclusion criteria

Asthma Group

  • History of daily oral steroid use during the month before treatment for the current exacerbation.
  • Use of a leukotriene antagonist.
  • Birth at ≥ 36 weeks gestation.

Control Group

  • History of asthma or reactive airway disease.
  • History of a prior illness with wheezing.
  • History of chronic cough (daily over the month prior to enrollment).
  • History of allergic rhinitis.
  • History of atopic dermatitis.
  • History of food allergies.
  • A URI or episode of sinusitis within 3 weeks of study entry.

Treatment and study plan

Primary outcomes

  1. FEV1

    Time frame: 1 month

Secondary outcomes

  1. FEF25-75

    Time frame: 1 month

  2. exhaled nitric oxide concentration

    Time frame: 1 month

  3. Breath condensate cysteinyl leukotriene concentration

    Time frame: 1 month

  4. albuterol use

    Time frame: 1 month

  5. school absence

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • AstraZeneca

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Oct 22, 2010
Registry last updated
Oct 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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