Childhood AsthmaNCT01472471
Urinary 8-isoprostane is Elevated in Acute Childhood Asthma
An observational study of Childhood Asthma and Oxidative Stress, run by Stony Brook University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Childhood Asthma, Oxidative Stress
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Group 1
- Patients aged 4-18 years
- Known stable asthmatics on no medications or with no medication changes in 3 weeks prior to enrollment
- No asthma hospitalizations in past 3 months
- Parent available to consent
- Group 2
Show all 9Show fewer
- Patients aged 4-18
- Known asthmatic, admitted to Stony Brook University Hospital for status asthmaticus
- Parent available to consent
Who cannot join
- Any child with documented fever within 24 hours of study entry
- Any child with a known current history of tracheo- or bronchomalacia
- Any child with known clinical or laboratory evidence of shock (see below)
- Any child with history of documented immunodeficiency, rheumatologic disease, cystic fibrosis, or renal dysfunction (see below)
- Any child with a current or recent (less than 1 year) history of tracheostomy
- Any child with a known genetic abnormality
Show all 9Show fewer
- Any pregnant child
- Any child with a history of autism
- Any child whose parent/caregiver is unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Long Island Children's Hospital at Stony Brook
Stony Brook, New York, 11794-8111
About this study
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.
- Conditions
- Childhood Asthma, Oxidative Stress
- Keywords
- Childhood Asthma, Oxidative stress, Urinary 8-isoprostane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| acute asthmatic children | Children hospitalized with a diagnosis of acute asthma exacerbation | |
| stable asthmatic children | Children with a history of asthma currently asymptomatic |
What is being measured
The primary outcome is the main question the study is designed to answer.
We expect to see increased urinary 8-isoprostane in acute pediatric asthmatics
Measured: Urinary 8-isoprostane levels were measured at the end of subject recruitment
Secondary outcomes (1)
We expect urinary 8-isoprostane levels to be higher with increased pediatric asthma severity.
Measured: This was calculated at the end of patient recruitment, after urinary 8-isoprostane levels were obtained
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startNov 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel E Sloniewsky, MD, Principal investigator, Long Island Children's Hospital at Stony Brook
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472471
- Sponsor's protocol ID
- 171086-4
- Status last verified
- Jun 2013
- First submitted
- 11 Nov 2011
- Last updated
- 6 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary 8-isoprostane is Elevated in Acute Childhood Asthma
- ClinicalTrials.gov ID
- NCT01472471
- Acronym / sponsor ID
- 171086-4
- Conditions
- Childhood Asthma, Oxidative Stress
- Keywords
- Childhood Asthma, Oxidative stress, Urinary 8-isoprostane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 16 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acute asthmatic children | – | –Children hospitalized with a diagnosis of acute asthma exacerbation |
| stable asthmatic children | – | –Children with a history of asthma currently asymptomatic |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (9 listed)
- Group 1
- Patients aged 4-18 years
- Known stable asthmatics on no medications or with no medication changes in 3 weeks prior to enrollment
- No asthma hospitalizations in past 3 months
- Parent available to consent
Key exclusion criteria (9 listed)
- Any child with documented fever within 24 hours of study entry
- Any child with a known current history of tracheo- or bronchomalacia
- Any child with known clinical or laboratory evidence of shock (see below)
- Any child with history of documented immunodeficiency, rheumatologic disease, cystic fibrosis, or renal dysfunction (see below)
- Any child with a current or recent (less than 1 year) history of tracheostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel E Sloniewsky, MD principal investigator
Long Island Children's Hospital at Stony Brook
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Asthma and Oxidative Stress, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2013; AzTrials last refreshed its copy on 6 Nov 2026.