Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
90 participants
OBSERVATIONAL
2012-01-31
2014-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Low Level Ozone Exposure on Healthy Volunteers
NCT00468221
Ozone Cardiovascular Effects in Genetically Susceptible People
NCT01192477
Effects of Chronic Ozone Exposure on Lung Function
NCT00006306
Acute Health Effects of Ozone Exposure
NCT03697174
Cardiopulmonary Responses to Exposure to Ozone and Diesel Exhaust
NCT01874834
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study will involve approximately 90 healthy volunteers aged ≥55 and ≤70 who meet strict criteria for inclusion. They will be exposed for 3 hours to clean air, 0.07 ppm O3 (near the current NAAQS), and 0.12 ppm O3 (a level measured in several locations in the US). A suite of cardiovascular and pulmonary endpoints will be measured on the day before the exposure and up to 22 hours after the exposures. The study is being conducted at three centers using a common protocol and common SOPs. Most the endpoints will be analyzed by core laboratories to reduce the variability in the results. A Data Coordination and Analysis Center will assemble all the data generated by the three centers and conduct the statistical analyses on the combined data sets.
The study has 3 main objectives:
1. To determine the relationship of altered autonomic balance (measured as changes in heart rate and heart rate variability (HRV)), cardiac arrhythmia, and repolarization and ozone exposure.
2. To identify instances of altered systemic vascular function \[measured as brachial artery flow-mediated dilation (FMD)without and with nitroglycerin (NTG) when exposed to ozone.
3. To identify pro-thrombotic vascular state (measured as increase in von Willebrand factor antigen in blood - primary endpoints) when exposed to ozone.
Additional objectives include:
1. To identify any increase in micro particle-associated tissues factor (measured as number of particles and tissue factor activity) and platelet activation) in ozone exposure.
2. To identify if markers of systemic oxidative stress and inflammation and any correlation with the cardiovascular effects and degree of airway injury (measured as CC16) and airway inflammatory effects (neutrophils and cytokines in induced sputum) in ozone exposure.
3. To determine if cardiovascular effects in ozone exposure are correlated with airway inflammatory effects, but not lung function effects.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
elderly subjects
Healthy
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Normal spirometry (FEV1 and FVC \>75% of predicted and FEV1/FVC \>0.65).
* Ability to complete the exposure exercise regimen chosen to induce a ventilation rate of 15 to 17 L/min/m2 without exceeding 80% of predicted maximal heart rate.
* Normal baseline 12-lead resting ECG, and absence of significant ST depression while performing the 15-minute required level of exercise targeted for the exposure period.
* Subjects must be able to avoid certain medication supplements listed for 1 week before the exposure.
Exclusion Criteria
* Including, but not limited to as ascertained by the physicians: Subjects with chronic cardiovascular (such as ischemic heart disease) or respiratory (such as asthma or COPD) disease; diabetes, or other organ or system dysfunction; cerebrovascular disease; active psychiatric disorders that would interfere with the subject's ability to understand and participate in the study. Subjects who have tested positive for a disease that affects the immune system (such as HIV, lymphoma, leukemia) or current drug or alcohol abuse (defined as having more than 3 drinks per day or being unable to abstain from alcohol for 3 days).
* Subjects with atopy or allergic rhinitis will not be excluded as long as they do not require regular treatment with antihistamines or systemic steroids.
* Ever-smokers (smoked tobacco or marijuana during the last five years, or with history of \>10 pack year for tobacco or \> 1 joint year for marijuana, or living with a smoker who smokes inside the house).
* Subject having plasma cotinine level \> 3ng/mL.
* BMI \>35 or \<18 (35 is the official cut off for class 1 obesity).
* Hypertension (defined as blood pressure \>140 systolic or \>90diastolic) or on anti-hypertension medications other than diuretics.
* Pregnancy or nursing (breastfeeding).
* On the following medications: prednisone, statins, beta-blockers, anticoagulants, current hormonal therapy, tamoxifen. Subjects will not be asked to discontinue needed prescription medications for the purpose of this study. If any of these medications becomes necessary during the course of the study, the subjects will be excluded. Use of other medications will be considered on an individual basis.
* Subjects taking aspirin or PDE5 inhibitors must be willing to abstain from these medications during the week preceding each exposure.
* Occupational exposures (exposed to high levels of vapors, dust, gases, or fumes on an on-going basis)
55 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Carelon Research
OTHER
University of California, San Francisco
OTHER
University of North Carolina, Chapel Hill
OTHER
University of Rochester
OTHER
Health Effects Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anne Stoddard, PhD
Role: PRINCIPAL_INVESTIGATOR
Carelon Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California at San Francisco
San Francisco, California, United States
New England Research Institutes, Inc.
Watertown, Massachusetts, United States
University of Rochester
Rochester, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Rich DQ, Thurston SW, Balmes JR, Bromberg PA, Arjomandi M, Hazucha MJ, Alexis NE, Ganz P, Zareba W, Thevenet-Morrison K, Koutrakis P, Frampton MW. Do Ambient Ozone or Other Pollutants Modify Effects of Controlled Ozone Exposure on Pulmonary Function? Ann Am Thorac Soc. 2020 May;17(5):563-572. doi: 10.1513/AnnalsATS.201908-597OC.
Arjomandi M, Balmes JR, Frampton MW, Bromberg P, Rich DQ, Stark P, Alexis NE, Costantini M, Hollenbeck-Pringle D, Dagincourt N, Hazucha MJ. Respiratory Responses to Ozone Exposure. MOSES (The Multicenter Ozone Study in Older Subjects). Am J Respir Crit Care Med. 2018 May 15;197(10):1319-1327. doi: 10.1164/rccm.201708-1613OC.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10-01-4
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.