Urinary 8-isoprostane is Elevated in Acute Childhood Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stony Brook University
ClinicalTrials.gov Identifier:
NCT01472471
First received: November 11, 2011
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

Oxidative stress is seen in children with asthma, but is hard to measure. The investigators exploring the utility of using a commercially available assay to measure oxidative stress in the urine in asthmatics. Additionally, the investigators will attempt to prove that oxidative stress is higher in children with acute asthma compared to those with stable asthma and that this stress is also higher in children with more severe clinical asthma exacerbations compared to less severe ones.


Condition
Childhood Asthma
Oxidative Stress

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Urinary 8-isoprostane is Elevated in Acute Childhood Asthma

Resource links provided by NLM:


Further study details as provided by Stony Brook University:

Primary Outcome Measures:
  • We expect to see increased urinary 8-isoprostane in acute pediatric asthmatics [ Time Frame: Urinary 8-isoprostane levels were measured at the end of subject recruitment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • We expect urinary 8-isoprostane levels to be higher with increased pediatric asthma severity. [ Time Frame: This was calculated at the end of patient recruitment, after urinary 8-isoprostane levels were obtained ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

urine


Enrollment: 52
Study Start Date: November 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
acute asthmatic children
Children hospitalized with a diagnosis of acute asthma exacerbation
stable asthmatic children
Children with a history of asthma currently asymptomatic

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Group 1:

25 subjects will be recruited from among the children seen at the Stony Brook University Pediatric Pulmonary and Allergy Clinic.

Group 2 25 subjects will be recruited from among the children admitted to Stony Brook University Hospital with a diagnosis of acute asthma exacerbation or reactive airway disease from Monday at 12 AM to Friday at 5 PM.

Criteria

Inclusion Criteria:

Group 1

  1. Patients aged 4-18 years
  2. Known stable asthmatics on no medications or with no medication changes in 3 weeks prior to enrollment
  3. No asthma hospitalizations in past 3 months
  4. Parent available to consent

Group 2

  1. Patients aged 4-18
  2. Known asthmatic, admitted to Stony Brook University Hospital for status asthmaticus
  3. Parent available to consent

Exclusion Criteria:

  1. Any child with documented fever within 24 hours of study entry
  2. Any child with a known current history of tracheo- or bronchomalacia
  3. Any child with known clinical or laboratory evidence of shock (see below)
  4. Any child with history of documented immunodeficiency, rheumatologic disease, cystic fibrosis, or renal dysfunction (see below)
  5. Any child with a current or recent (less than 1 year) history of tracheostomy
  6. Any child with a known genetic abnormality
  7. Any pregnant child
  8. Any child with a history of autism
  9. Any child whose parent/caregiver is unable to give informed consent
  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: NCT01472471

Locations
United States, New York
Long Island Children's Hospital at Stony Brook
Stony Brook, New York, United States, 11794-8111
Sponsors and Collaborators
Stony Brook University
Investigators
Principal Investigator: Daniel E Sloniewsky, MD Long Island Children's Hospital at Stony Brook
  More Information

No publications provided

Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT01472471     History of Changes
Other Study ID Numbers: 171086-4
Study First Received: November 11, 2011
Last Updated: June 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stony Brook University:
Childhood Asthma
Oxidative stress
Urinary 8-isoprostane

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
8-epi-prostaglandin F2alpha
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014