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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01227070
First received: October 20, 2010
Last updated: NA
Last verified: October 2010
History: No changes posted
  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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • FEV1 [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEF25-75 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • exhaled nitric oxide concentration [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Breath condensate cysteinyl leukotriene concentration [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • albuterol use [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • school absence [ Time Frame: 1 month ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 20, 2010
Last Updated: October 20, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014