Urinary 8-isoprostane is Elevated in Acute Childhood Asthma

Oxidative Stress Clinical Trial

Official title:

Urinary 8-isoprostane is Elevated in Acute Childhood Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472471
• Other study ID #: 171086-4
• Status: Completed
• Phase: N/A
• First received: November 11, 2011
• Last updated: June 5, 2013
• Start date: November 2010
• Est. completion date: February 2012

Study information

• Verified date: June 2013
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 18 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Childhood Asthma
• Oxidative Stress

Locations

Country	Name	City	State
United States	Long Island Children's Hospital at Stony Brook	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Stony Brook University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	We expect to see increased urinary 8-isoprostane in acute pediatric asthmatics		Urinary 8-isoprostane levels were measured at the end of subject recruitment	No
Secondary	We expect urinary 8-isoprostane levels to be higher with increased pediatric asthma severity.		This was calculated at the end of patient recruitment, after urinary 8-isoprostane levels were obtained	No