ObesityOBOZNCT00839943
Effect Of Obesity On Ozone-Induced Airway Inflammation
A study testing ozone, 0.4 ppm in people with Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to compare the effect of ozone exposure on airway reactivity and inflammation in obese vs. non-obese adults. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- ozone, 0.4 ppm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Feb 2012
- Phase
- Interventional
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Twenty (20) non-obese, non-overweight (body mass index, 18 kg/m2 > BMI < 25 kg/m2, waist circumference < 35 inches) subjects and 20 obese (30 kg/m2 > BMI < 38 kg/m2, waist circumference >= 35 inches) volunteer females between 18-35 yrs of age
Who cannot join
- Are female and pregnant or have any reason to believe you might be pregnant.
- Are not between 18 and 35 years old.
- Have a history of asthma or have current hay fever.
- Have ever smoked more than 10 cigarettes (one half pack) a month or smoked during the past 30 days.
- Have a history of acute or chronic cardiovascular disease, chronic respiratory disease, and acute respiratory illness within 4 weeks.
- Have contraindications for performing sustained light exercise.
- You've been in a recent or recurring exposure to a dusty environment at work
- If you are unwilling to refrain from strenuous physical activity for 24 hours before and after each exposure.
Trial locations and contacts
1 site in 1 country.
United States1 site
US EPA Human Studies Facility-UNC -CH campus
Chapel Hill, North Carolina, 27599
About this study
The purpose of this study is to compare the effect of ozone exposure on airway reactivity and inflammation in obese vs. non-obese adults.
Read the detailed description
Obesity has been shown to be associated with initial onset of asthma in children and increased airway hyperresponsiveness in adults (1,2). An important aspect of these epidemiologic data is that the impact of obesity on asthma is much stronger in females than males. For example, the incidence of asthma after the age of 11 years is five- to sevenfold higher in female children who become obese versus those who remain lean, whereas no such relationship exists for males (3). Recent mouse models of obesity suggest that this condition enhances airway responses to ozone air pollution (4). These mice eat excessively due to a defect in the gene encoding leptin, a satiety hormone produced in adipocytes. Shore et al (4) showed that these leptin-deficient obese mice had greater airway hyperreactivity to i.v. methacholine following ozone exposure compared to lean, wild-type mice. Furthermore, administration of exogenous leptin (which is actually increased in the serum of obese individuals (4)) was shown to enhance ozone-induced cytokine and protein release into BAL fluid of lean, wild type mice (4). Reduced lung volumes and altered breathing patterns in the obese may also contribute to enhanced airway reactivity in these patients (5). Stretch of airway smooth muscle during tidal breathing and especially during deep breaths, i.e. sighs, acts as a potent bronchodilator that might ameliorate ozone-induced bronchoconstriction. The increased chest load associated with obesity may also diminish tidal breathing volumes and frequency of sighs during ozone exposure.
- Conditions
- Obesity
- Being tested
- ozone, 0.4 ppm
- Keywords
- ozone, clean air
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ozone, 0.4 ppmOther
2 hour ozone exposure, 0.40 ppm
| Study group | Role | What they receive |
|---|---|---|
| ozone | Active comparator | obese vs non-obese women Receives: Other: ozone, 0.4 ppm |
| air | Active comparator | obese vs non obese women Receives: Other: ozone, 0.4 ppm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methacholine reactivity (primary endpoint)
Measured: 2-4 hours post exposure
Secondary outcomes (2)
Breathing and lung function variables
Measured: immediately post exposure, 24 post exposure
induced sputum markers
Measured: 4 hours post exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startMay 2006
- 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 ObesityStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), Environmental Protection Agency (EPA)
- Responsible party
- Sponsor
- Investigators
- William Bennett, PhD, Principal investigator, University of North Carolina, Chapel HillStephanie London, MD, PhD, Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839943
- Sponsor's protocol ID
- 05-CEMLB-128
- Other IDs
- IRB 05-1644
- Acronym
- OBOZ
- Status last verified
- Jun 2012
- First submitted
- 6 Feb 2009
- Last updated
- 27 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Obesity On Ozone-Induced Airway Inflammation
- ClinicalTrials.gov ID
- NCT00839943
- Acronym / sponsor ID
- OBOZ / 05-CEMLB-128
- Conditions
- Obesity
- Keywords
- ozone, clean air
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Environmental Health Sciences (NIEHS), Environmental Protection Agency (EPA)
- Study start
- May 2006
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 10 Feb 2009 (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.
The purpose of this study is to compare the effect of ozone exposure on airway reactivity and inflammation in obese vs. non-obese adults.
Detailed description
Obesity has been shown to be associated with initial onset of asthma in children and increased airway hyperresponsiveness in adults (1,2). An important aspect of these epidemiologic data is that the impact of obesity on asthma is much stronger in females than males. For example, the incidence of asthma after the age of 11 years is five- to sevenfold higher in female children who become obese versus those who remain lean, whereas no such relationship exists for males (3). Recent mouse models of obesity suggest that this condition enhances airway responses to ozone air pollution (4). These mice eat excessively due to a defect in the gene encoding leptin, a satiety hormone produced in adipocytes. Shore et al (4) showed that these leptin-deficient obese mice had greater airway hyperreactivity to i.v. methacholine following ozone exposure compared to lean, wild-type mice. Furthermore, administration of exogenous leptin (which is actually increased in the serum of obese individuals (4)) was shown to enhance ozone-induced cytokine and protein release into BAL fluid of lean, wild type mice (4). Reduced lung volumes and altered breathing patterns in the obese may also contribute to enhanced airway reactivity in these patients (5). Stretch of airway smooth muscle during tidal breathing and especially during deep breaths, i.e. sighs, acts as a potent bronchodilator that might ameliorate ozone-induced bronchoconstriction. The increased chest load associated with obesity may also diminish tidal breathing volumes and frequency of sighs during ozone exposure.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ozone | Active comparator | Other: ozone, 0.4 ppmobese vs non-obese women |
| air | Active comparator | Other: ozone, 0.4 ppmobese vs non obese women |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Twenty (20) non-obese, non-overweight (body mass index, 18 kg/m2 > BMI < 25 kg/m2, waist circumference < 35 inches) subjects and 20 obese (30 kg/m2 > BMI < 38 kg/m2, waist circumference >= 35 inches) volunteer females between 18-35 yrs of age
Key exclusion criteria (8 listed)
- Are female and pregnant or have any reason to believe you might be pregnant.
- Are not between 18 and 35 years old.
- Have a history of asthma or have current hay fever.
- Have ever smoked more than 10 cigarettes (one half pack) a month or smoked during the past 30 days.
- Have a history of acute or chronic cardiovascular disease, chronic respiratory disease, and acute respiratory illness within 4 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ozone, 0.4 ppm2 hour ozone exposure, 0.40 ppm | Other | air, ozone |
Primary outcome
Methacholine reactivity (primary endpoint)
Time frame: 2-4 hours post exposure
2 secondary outcomes
Breathing and lung function variables
Time frame: immediately post exposure, 24 post exposure
induced sputum markers
Time frame: 4 hours post exposure
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 27 Aug 2012.
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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.
William Bennett, PhD principal investigator
University of North Carolina, Chapel Hill
Stephanie London, MD, PhD principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ozone, 0.4 ppm in people with Obesity, run by University of North Carolina, Chapel Hill 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 1 inclusion and 8 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 27 Aug 2012. 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?
Methacholine reactivity (primary endpoint) (time frame: 2-4 hours post exposure). 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 27 Aug 2012.