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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01914783
Other study ID # MHH-Particles EK-6142
Secondary ID
Status Recruiting
Phase N/A
First received July 30, 2013
Last updated July 31, 2013
Start date July 2013
Est. completion date December 2015

Study information

Verified date July 2013
Source Hannover Medical School
Contact Marcus May, MD
Phone +49 511 532
Email may.marcus@mh-hannover.de
Is FDA regulated No
Health authority Germany: Ethics CommissionGermany: Federal Ministry of Education and Research
Study type Interventional

Clinical Trial Summary

The primary hypothesis of the study is that in healthy elderly subjects experimental exposure to air pollutants increases sympathetic nervous system activity compared with sham (clean air) exposure. The secondary hypothesis of the study is that combined experimental exposure to air pollutants (particles + ozone) increases sympathetic nervous system activity to a greater extent than does the exposure to particles alone.


Description:

In a randomized, double-blind, and cross-over fashion, the participants will be exposed to clean air, ultrafine particles, or ultrafine particles and ozone in an exposure chamber. The investigators will determine blood pressure, heart rate, respiration as well as cardiac output and directly record sympathetic vasomotor tone using the microneurography technique. To elucidate the underlying mechanisms through which particles and ozone affect the autonomic nervous system, the investigators will assess the local and systemic inflammatory response as well as the changes in neurotrophic factors in sputum and blood. In addition, the activation of inflammatory cells in sputum and blood will be analyzed at different points in time after exposures. Changes in sympathetic activity will be correlated with the degree of airway inflammation and oxidative stress assessed in induced sputum and blood. This study will provide important insight in the mechanisms through which air pollution, particularly ultrafine particle exposure, increases cardiovascular risk in human subjects and generate a human model for mechanistic and therapeutic studies.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Elderly man or postmenopausal woman older than 50 years of age.

- Signed written informed consent.

Exclusion Criteria:

- Smoker.

- Cardiovascular and/or pulmonary disease.

- Medication with relevant impact on autonomic system function, e. g. norepinephrine reuptake inhibitors. Stable medication with slight to moderate autonomic effects is tolerable.

- Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.

- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

- Subject unlikely to comply with protocol, e. g. uncooperative attitude or unlikelihood of completing the study.

- Known hypersensitivity to ozone.

- History of drug or alcohol abuse. Particles Study - Protocol version: October 19, 2012 14

- Blood donation of more than 500 mL during the previous 3 months.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
ultrafine particles
exposure to ultrafine particles
ultrafine particles and ozone
exposure to ultrafine particles and ozone
clean air
Exposure to clean air.

Locations

Country Name City State
Germany Hannover Medical School Hannover

Sponsors (2)

Lead Sponsor Collaborator
Hannover Medical School Fraunhofer-Institute of Toxicology and Experimental Medicine

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Tank J, Biller H, Heusser K, Holz O, Diedrich A, Framke T, Koch A, Grosshennig A, Koch W, Krug N, Jordan J, Hohlfeld JM. Effect of acute ozone induced airway inflammation on human sympathetic nerve traffic: a randomized, placebo controlled, crossover study. PLoS One. 2011 Apr 8;6(4):e18737. doi: 10.1371/journal.pone.0018737. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Blood pressure Change of blood pressure in mmHg. 2.5 hours after exposure to clean air, to ultrafine particles, or to a combination of ultrafine particles and ozone No
Other Heart rate Change of heart rate in beat per minute. 2.5 hours after exposure to clean air, to ultrafine particles, or to a combination of ultrafine particles and ozone No
Other Cardiac output Change of cardiac output in l/min. 2.5 hours after exposure to clean air, to ultrafine particles, or to a combination of ultrafine particles and ozone No
Other Total peripheral resistance Change in total peripheral resistance expressed as dyn*s/cm^5. 2.5 hours after exposure to clean air, to ultrafine particles, or to a combination of ultrafine particles and ozone No
Other Heart rate variability. Change in heart rate variability parameters in the time and frequency domain. 2.5 hours after exposure to clean air, to ultrafine particles, or to a combination of ultrafine particles and ozone No
Other Plasma norepinephrine concentration Change of plasma norepinephrine in ng/l. 2.5 hours after exposure to clean air, to ultrafine particles, or to a combination of ultrafine particles and ozone No
Other Plasma renin concentration Change of plasma renin concentration in 2.5 hours after exposure to clean air, to ultrafine particles, or to a combination of ultrafine particles and ozone No
Other Baroreflex sensitivity Change in baroreflex sensitivity expressed as ms/mmHg. 2.5 hours after exposure to clean air, to ultrafine particles, or to a combination of ultrafine particles and ozone No
Other Inflammation parameters Change of the percentage of neutrophils in induced sputum. 3.5 hours after exposure to clean air, to ultrafine particles, or to a combination of ultrafine particles and ozone No
Other Oxidative stress parameters Change of plasma malondialdehyde(MDA)concentration. 2.5 hours after exposure to clean air, to ultrafine particles, or to a combination of ultrafine particles and ozone No
Other Correlation between inflammation, oxidative stress and cardiovascular regulation Correlation coefficients between changes in parameters for inflammation and oxidative stress with changes in cardiovascular parameters. 2.5 hours after exposure to clean air, to ultrafine particles, or to a combination of ultrafine particles and ozone No
Other Forced expiratory volume in one second (FEV1) Change in FEV1 in l 2.5 hours after exposure to clean air, to ultrafine particles, or to a combination of ultrafine particles and ozone No
Other Forced vital capacity (FVC) Change in FVC in l. 2.5 hours after exposure to clean air, to ultrafine particles, or to a combination of ultrafine particles and ozone No
Other Percentage of neutrophils in peripheral blood Change of percentage of neutrophils in peripheral blood. 2.5 hours after exposure to clean air, to ultrafine particles, or to a combination of ultrafine particles and ozone No
Primary Muscle sympathetic nerve activity (MSNA) Change of sympathetic vasoconstrictor nerve activity directed to skeletal muscle expressed as sympathetic bursts per minute. The primary hypothesis of the study is that in healthy elderly subjects experimental exposure to air pollutants increases sympathetic nervous system activity compared with sham (clean air) exposure. 2.5 hours after exposure to clean air, to ultrafine particles, or to a combination of ultrafine particles and ozone No
Secondary MSNA burst incidence Change of MSNA expressed as bursts/100 heart beats. 2.5 hours after exposure to clean air, to ultrafine particles, or to a combination of ultrafine particles and ozone No
Secondary total MSNA Change of MSNA expressed as burst area/min. 2.5 hours after exposure to clean air, to ultrafine particles, or to a combination of ultrafine particles and ozone No
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