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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01227070
First Posted: October 22, 2010
Last Update Posted: October 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by:
Seattle Children's Hospital
  Purpose

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.

Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Airflow Obstruction and Biomarkers of Airway Inflammation During and Following Acute Exacerbations of Childhood Asthma

Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • FEV1 [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • FEF25-75 [ Time Frame: 1 month ]
  • exhaled nitric oxide concentration [ Time Frame: 1 month ]
  • Breath condensate cysteinyl leukotriene concentration [ Time Frame: 1 month ]
  • albuterol use [ Time Frame: 1 month ]
  • school absence [ Time Frame: 1 month ]

Biospecimen Retention:   Samples Without DNA
Exhaled breath condensate

Enrollment: 80
Study Start Date: January 2006
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Asthmatic
Healthy Control

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
children ages 6-18 years hospitalized for an asthmat exacerbation, similar aged healthy control children
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01227070


Locations
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98115
Sponsors and Collaborators
Seattle Children's Hospital
AstraZeneca
Investigators
Principal Investigator: Jason S Debley, MD, MPH Seattle Children's Hospital
  More Information

Responsible Party: Jason Debley, MD, MPH, Seattle Chidlren's Hospital
ClinicalTrials.gov Identifier: NCT01227070     History of Changes
Other Study ID Numbers: SCH IRB 11798
IRUSBUPR0055 ( Other Grant/Funding Number: AstraZeneca )
First Submitted: October 20, 2010
First Posted: October 22, 2010
Last Update Posted: October 22, 2010
Last Verified: October 2010

Keywords provided by Seattle Children's Hospital:
Asthma, hospitalization, children, exhaled nitric oxide, lung function, breath condensate, cysteinyl leukotrienes

Additional relevant MeSH terms:
Asthma
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes