AsthmaNCT01158573
Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity
An observational study of Asthma and Obesity, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to examine whether there are higher levels of cysteinyl leukotrienes in obese subjects than in non-obese subjects. Cysteinyl leukotrienes are pro-inflammatory substances that cause asthma by narrowing the airways of the lung. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to May 2013
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: UM Housing Residents/Student Dorms UM Human Research Recruiting Registry (e.g., ENGAGE - http://www.med.umich.edu/engage/) Department or unit-specific research recruiting registry (provide UM IRB project number below) Other UM subject pools (describe below) Patients or their medical records from the UM Health System or any other UM health care provider (e.g., School of Dentistry, University Health Service, University Center for Language and Literacy)
Who may be able to join
- 18-65 yr old adults with asthma, non-smoking for at least one year
- Healthy non-smoking adults, aged 18-65 without asthma
- Heavy subjects with BMI > 30 kg/m2
- Subjects with normal weight (BMI between 20-25 kg/m2)
- Subject not taking anti-leukotriene therapy (Singulair, Accolate, Zyflo)
Who cannot join
- No chronic oral steroid use
- No recent history of infection
- No recent history of flare of lung disease
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine whether there are higher levels of cysteinyl leukotrienes in obese subjects than in non-obese subjects. Cysteinyl leukotrienes are pro-inflammatory substances that cause asthma by narrowing the airways of the lung. The investigators want to see if subjects with increased fat stores and therefore increased leptin, which is a fat-related protein that regulates leukotrienes, have increased levels of leukotrienes in the blood, lung and urine. The investigators would also like to determine the relationship between cysteinyl leukotrienes and exhaled nitric oxide levels in asthmatics with and without obesity. Nitric oxide is anti-inflammatory and suppresses leukotriene synthesis.
Read the detailed description
This is a cross-sectional observational study to characterize the association between obese asthmatics and the inflammatory mediators cysteinyl leukotrienes. Our hypothesis is that altered adipokine levels in obesity result in augmented cysteinyl leukotriene synthesis that play a significant role in the pathogenesis of asthma in these subjects.
- Keywords
- Asthma, Obesity
- Medical subject headings
- Asthma, Obesity
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 |
|---|---|---|
| Healthy non-asthmatic obese adults | Healthy non-asthmatic obese adults | |
| Healthy non-asthmatic non-obese adults | Healthy non-asthmatic non-obese adults | |
| Asthmatic obese adults | Asthmatic obese adults | |
| Asthmatic non-obese adults | Asthmatic non-obese adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Leptin
Measurement of plasma leptin in obese and non obese asthmatics and non-asthmatic subjects from a single blood draw.
Measured: Observational: one time point from a blood draw after more than 6 hours fasting
Exhaled Nitric Oxide (FeNO)
Exhaled breath nitic oxide ppb (averaged values from 2 exhalations per participant)
Measured: Observational: Two exhalations within 1 minute
Urine Cysteinyl Leukotriene Per Creatinine
Urine inflammatory mediators measured from a single urine sample
Measured: sample taken over 5 minutes or less
Ratio U Cys-LT/FeNO
Responsiveness to leukotriene modifier medication by measuring the urine cysteinyl leukotriene/exhaled nitric oxide ratio
Measured: sample taken over 5 minutes or less
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionMay 2013
- Study completionMay 2013
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 University of MichiganThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Michael Coffey, University of Michigan
- Investigators
- Michael Coffey, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158573
- Sponsor's protocol ID
- 36879
- Status last verified
- Jun 2017
- First submitted
- 7 Jul 2010
- Last updated
- 24 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Cysteinyl Leukotrienes in the Pathogenesis of Asthma in Obesity
- ClinicalTrials.gov ID
- NCT01158573
- Acronym / sponsor ID
- 36879
- Keywords
- Asthma, Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2010
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Posted 24 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine whether there are higher levels of cysteinyl leukotrienes in obese subjects than in non-obese subjects. Cysteinyl leukotrienes are pro-inflammatory substances that cause asthma by narrowing the airways of the lung. The investigators want to see if subjects with increased fat stores and therefore increased leptin, which is a fat-related protein that regulates leukotrienes, have increased levels of leukotrienes in the blood, lung and urine. The investigators would also like to determine the relationship between cysteinyl leukotrienes and exhaled nitric oxide levels in asthmatics with and without obesity. Nitric oxide is anti-inflammatory and suppresses leukotriene synthesis.
Detailed description
This is a cross-sectional observational study to characterize the association between obese asthmatics and the inflammatory mediators cysteinyl leukotrienes. Our hypothesis is that altered adipokine levels in obesity result in augmented cysteinyl leukotriene synthesis that play a significant role in the pathogenesis of asthma in these subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy non-asthmatic obese adults | – | –Healthy non-asthmatic obese adults |
| Healthy non-asthmatic non-obese adults | – | –Healthy non-asthmatic non-obese adults |
| Asthmatic obese adults | – | –Asthmatic obese adults |
| Asthmatic non-obese adults | – | –Asthmatic non-obese adults |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- UM Housing Residents/Student Dorms UM Human Research Recruiting Registry (e.g., ENGAGE - http://www.med.umich.edu/engage/) Department or unit-specific research recruiting registry (provide UM IRB project number below) Other UM subject pools (describe below) Patients or their medical records from the UM Health System or any other UM health care provider (e.g., School of Dentistry, University Health Service, University Center for Language and Literacy)
Key inclusion criteria (5 listed)
- 18-65 yr old adults with asthma, non-smoking for at least one year
- Healthy non-smoking adults, aged 18-65 without asthma
- Heavy subjects with BMI > 30 kg/m2
- Subjects with normal weight (BMI between 20-25 kg/m2)
- Subject not taking anti-leukotriene therapy (Singulair, Accolate, Zyflo)
Key exclusion criteria (3 listed)
- No chronic oral steroid use
- No recent history of infection
- No recent history of flare of lung 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
Plasma Leptin
Time frame: Observational: one time point from a blood draw after more than 6 hours fasting
Measurement of plasma leptin in obese and non obese asthmatics and non-asthmatic subjects from a single blood draw.
Exhaled Nitric Oxide (FeNO)
Time frame: Observational: Two exhalations within 1 minute
Exhaled breath nitic oxide ppb (averaged values from 2 exhalations per participant)
Urine Cysteinyl Leukotriene Per Creatinine
Time frame: sample taken over 5 minutes or less
Urine inflammatory mediators measured from a single urine sample
Ratio U Cys-LT/FeNO
Time frame: sample taken over 5 minutes or less
Responsiveness to leukotriene modifier medication by measuring the urine cysteinyl leukotriene/exhaled nitric oxide ratio
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2018.
- 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.
Michael Coffey, MD principal investigator
University of Michigan
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 and Obesity, run by University of Michigan 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 5 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 24 Jan 2018. 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 24 Jan 2018). 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?
Plasma Leptin (time frame: Observational: one time point from a blood draw after more than 6 hours fasting). The study lists 4 primary outcomes in all. 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 24 Jan 2018.