NCT01192477

Brief Summary

Increases in air pollution are associated with increases in deaths from cardiovascular disease, but the investigators know little about how ozone air pollution affects the cardiovascular system. The investigators proposed study will determine the effects of ozone on blood vessel and heart function that could worsen illness in people with underlying heart disease. This will be accomplished by studying healthy volunteers who inhale ozone in a controlled clinical study, and also by studying their exposure to ozone and other pollutants during their normal daily activities. The investigators will study volunteers who may be at increased risk for the effects of ozone because of genetic susceptibility. Understanding the effects of ozone on the heart and circulation can help establish appropriate air pollution standards, and provide strategies to protect the most susceptible people.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started May 2011

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2010

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

December 4, 2013

Status Verified

December 1, 2013

Enrollment Period

1.3 years

First QC Date

August 30, 2010

Last Update Submit

December 2, 2013

Conditions

Healthy

Keywords

Air pollutionOzoneHealth effects of ozone exposure

Outcome Measures

Primary Outcomes (1)

  • Nitric oxide bioavailability

    We hypothesize that systemic vascular effects of exposure to ozone will be reflected in reductions in arterial blood nitrite or its A/V gradient. This will require simultaneous collection of venous and arterial blood.

    Before and 3 hours after ozone exposure

Secondary Outcomes (1)

  • Evidence of endothelial injury

    Before and 3 hours after ozone exposure

Study Arms (3)

Ozone 0.1 ppm

EXPERIMENTAL
Other: Ozone

Ozone 0.2 ppm

EXPERIMENTAL
Other: Ozone

Filtered air

SHAM COMPARATOR
Other: Ozone

Interventions

OzoneOTHER

All subjects will have a 3-hour exposure to clean air, a 3-hour exposure to clean air with lower ozone (0.1 ppm), and a 3-hour exposure to clean air with higher ozone (0.2 ppm). Exposures will take place at least 3 weeks apart. Order of exposure will be randomized for each subject.

Also known as: Ozone exposure, Ozone air pollution
Filtered airOzone 0.1 ppmOzone 0.2 ppm

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy,
  • Never-smokers with normal spirometry based on the standards published by Morris and co-workers (Morris et al. 1971), and
  • A normal electrocardiogram. -

You may not qualify if:

  • Any history of habitual smoking.
  • Marijuana smoking within the past 5 years.
  • Pregnancy.
  • Any history of significant organ impairment, chronic respiratory disease, ischemic heart disease, active psychiatric disorder or current drug or alcohol abuse.
  • Occupation involving regular, heavy dust or particle exposure, such as welding, mining, foundry work.
  • FEV1 \< 75% of predicted at baseline screening.
  • Subjects with atopy or allergic rhinitis will not be excluded as long as they do not require regular treatment with antihistamines or systemic steroids.
  • Subjects on certain prescription medications such as prednisone or statins will be excluded. Use of other medications will be considered on an individual basis. Subjects will not be asked to discontinue prescription medications for the purposes of this study.
  • Hypertension (blood pressure higher than 140/90 mmHg or on antihypertensive medication).
  • Subject lives outside the Rochester metropolitan area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Ozone

Intervention Hierarchy (Ancestors)

OxygenGasesInorganic Chemicals

Study Officials

  • Mark Frampton, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 30, 2010

First Posted

September 1, 2010

Study Start

May 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

December 4, 2013

Record last verified: 2013-12

Locations

US(1)