AsthmaSARPNCT00590005
Redox Determinants of Severe Asthma (a Substudy of the Severe Asthma Research Program)
An observational study of Asthma, run by Emory University at 1 site in United States.
Trial summary
Hypotheses: 1) Airway pH regulation is abnormal in severe asthma; 2) In severe asthma, there is formation of cytotoxic nitrogen oxides and loss of beneficial nitrogen oxides in the airways Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Asthma
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Jun 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population consists of children with physician-diagnosed asthma in the Atlanta, Georgia area across a wide range of asthma severities (mild, moderate, severe)
Who may be able to join
- At least 6 years old
- Asthma diagnosis by physician
- Current treatment with an inhaled corticosteroid medication
Who cannot join
- Bronchiectasis
- Cystic Fibrosis
- Chronic Obstructive Pulmonary Disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Redox Determinants of Severe Asthma: A Substudy of the NHLBI Severe Asthma Research Program
Hypotheses: 1) Airway pH regulation is abnormal in severe asthma; 2) In severe asthma, there is formation of cytotoxic nitrogen oxides and loss of beneficial nitrogen oxides in the airways
Read the detailed description
Specific Aim 1:Test hypothesis that airway pH regulation is abnormal in severe asthma.
1a) Determine the effects of systemic corticosteroids on breath pH in children with severe and mild to moderate asthma.
1b) Examine whether breath condensate pH and other biomarkers of oxidant stress can predict clinical outcomes in children with severe and mild to moderate asthma.
1c) Identify whether increased Th1/Th2 cytokine ratio, and abnormalities in airway glutaminase, G-SNO-reductase, VATPase, and carbonic anhydrase are associated with airway pH disturbance in children with severe asthma.
1d) Test whether rhinovirus infections, which reduce airway pH, persist longer or are more frequent in children with severe asthma than in children with mild to moderate asthma.
1e) Examine the relationship between gastroesophageal reflux and proximal airway pH in children with severe asthma and mild to moderate asthma.
- Conditions
- Asthma
- Keywords
- severe asthma, poorly controlled asthma
- Medical subject headings
- Asthma
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 |
|---|---|---|
| Children with severe asthma | This group consists of children with severe asthma as defined per ATS workshop criteria (published in 2000). | |
| Children with non-severe asthma | This group includes children with asthma who do not meet the ATS criteria for severe asthma as outlined in the 2000 workshop report. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exhaled Nitric Oxide at Baseline and Over the Observational Period
Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag
Measured: baseline and after 21 days
Secondary outcomes (1)
Reduction in Breath pH
Breath condensate pH was measured by the RTube (trademark) device. This device is a plastic tube with a one-way exhalation valve and a chilled aluminum sleeve. pH (the log of hydrogen ion concentration) was measured using an Orion pH meter and probe calibrated in 4.0, 7.0, and 10.0 pH solutions.
Measured: baseline and 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2008 (estimated)
- Study startJan 2003
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Principal investigator, Anne M Fitzpatrick PhD, Emory University
- Investigators
- W G Teague, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590005
- Sponsor's protocol ID
- IRB00024906
- Other IDs
- 2R01HL069170-07
- Acronym
- SARP
- Status last verified
- Jan 2014
- First submitted
- 27 Dec 2007
- Last updated
- 10 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redox Determinants of Severe Asthma: A Substudy of the NHLBI Severe Asthma Research Program
- ClinicalTrials.gov ID
- NCT00590005
- Acronym / sponsor ID
- SARP / IRB00024906
- Conditions
- Asthma
- Keywords
- severe asthma, poorly controlled asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- The Cleveland Clinic
- Study start
- Jan 2003
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 10 Jan 2008 (estimated)
- Results
- Posted 13 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypotheses: 1) Airway pH regulation is abnormal in severe asthma; 2) In severe asthma, there is formation of cytotoxic nitrogen oxides and loss of beneficial nitrogen oxides in the airways
Detailed description
Specific Aim 1:Test hypothesis that airway pH regulation is abnormal in severe asthma.
1a) Determine the effects of systemic corticosteroids on breath pH in children with severe and mild to moderate asthma.
1b) Examine whether breath condensate pH and other biomarkers of oxidant stress can predict clinical outcomes in children with severe and mild to moderate asthma.
1c) Identify whether increased Th1/Th2 cytokine ratio, and abnormalities in airway glutaminase, G-SNO-reductase, VATPase, and carbonic anhydrase are associated with airway pH disturbance in children with severe asthma.
1d) Test whether rhinovirus infections, which reduce airway pH, persist longer or are more frequent in children with severe asthma than in children with mild to moderate asthma.
1e) Examine the relationship between gastroesophageal reflux and proximal airway pH in children with severe asthma and mild to moderate asthma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with severe asthma | – | –This group consists of children with severe asthma as defined per ATS workshop criteria (published in 2000). |
| Children with non-severe asthma | – | –This group includes children with asthma who do not meet the ATS criteria for severe asthma as outlined in the 2000 workshop report. |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population consists of children with physician-diagnosed asthma in the Atlanta, Georgia area across a wide range of asthma severities (mild, moderate, severe)
Key inclusion criteria (3 listed)
- At least 6 years old
- Asthma diagnosis by physician
- Current treatment with an inhaled corticosteroid medication
Key exclusion criteria (3 listed)
- Bronchiectasis
- Cystic Fibrosis
- Chronic Obstructive Pulmonary Disease
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
Exhaled Nitric Oxide at Baseline and Over the Observational Period
Time frame: baseline and after 21 days
Exhaled nitric oxide concentrations as measured by collection of exhaled breath into a mylar bag
1 secondary outcome
Reduction in Breath pH
Time frame: baseline and 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
W G Teague, MD principal investigator
University of Virginia
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 Asthma, run by Emory 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 3 inclusion and 3 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 10 Feb 2014. 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?
Yes. Results are posted in the registry (first posted 13 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Exhaled Nitric Oxide at Baseline and Over the Observational Period (time frame: baseline and after 21 days). 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 10 Feb 2014.