Acute Changes in Cardiovascular Outcomes Clinical Trial
— XDOZOfficial title:
Controlled Human Exposure to Indoor Air, Dust and Ozone
The aim of the study is to provide information which may help to improve the quality of the
life of persons exposed to indoor environments in Danish dwellings.
The experiment will document if dust and ozone contribute to deterioration of indoor air
quality and to the occurrence of symptoms and health effects.
The study is aimed at testing the hypothesis that the presence of ozone potentiate the
health and comfort effects of dust exposure in the indoor environment.
Testing this hypothesis will be based on the following questions:
Does house dust and ozone in concentrations frequently encountered in Danish dwellings cause
unwanted health effects either by themselves or by interaction?
If so, does the presence of ozone potentiate the expected irritative effects of dust?
The challenge of these hypotheses will be made as a controlled experiment on humans in a
climate chamber under controlled exposure conditions.
This controlled human experiment should be able to substantiate the findings from the
intervention studies.
Furthermore, they ideally reflect something relevant to the general public and therefore
should have maximum public appeal and application possibilities.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | July 2013 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 60 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Non-smoker - Normal lung function - No active allergic rhinitis - Be free from clinically significant cardiac, pulmonary, neurological and psychiatric disease as determined by medical history, physical examination and screening investigations. - With no clinically-significant deviation outside the normal ranges for blood presure and pulse Measurements. - Capable of giving informed consent - Be avaible to complete the study - Provide oral and written informed consent to participate in the study Exclusion Criteria: - Atopy - Upper respiratory tract infection within 2 weeks - Medical conditions likely to affect the outcome of the study in the opion of the investigator. - Presence of any respiratory disease - Infection of the upper Airways/lower Airways includingviral infections in the 14 days prior to screening and at the start of/or during the study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Aarhus University, Scholle of Public Health, Dept. of Environmental & Occupational Medicine | Aarhus |
| Lead Sponsor | Collaborator |
|---|---|
| University of Aarhus |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | To assess the effects on lower airway via FeNO | The device is to measure NO gas concentrations in the participants exhaled breath. FeNO Measurements are used as parameter of airway inflammation. | On each study day: Baseline, 5½-h post exposure and follow-up 24-h | No |
| Other | To assess general irritation using a VAS Scale | Assess symptoms with a standard VAS scale procedure where the Integrated irritations of throat , nose and eyes are evaluated. The more irritation the higher the percentage are registered. Ratings are made during exposures, no pre- and post exposure Measurements are made . A sound signal tells the participants to make an evalutation and to adjust the indicator on the potentiometer. | On every 30th min. during the exposure. | No |
| Other | Total Ocular Symptom Score (TOSS) | The total ocular symptom score (TOSS) consists of three symptoms; eye itching, eye watering and eye swollenness as TOSS. Outcome measures were difference in maximum TOSS between the four treatments and the difference in daily TOSS. | TOSS outcomes were conducted at baseline, immediately after exposure (½ + 3½ hours) and the end of exposure (5½ post exposure initiation). | No |
| Other | Total Nasal Symptom Score | The total Nasal Symptom Score (TNSS) consists of four symptoms; nasal congestion, rhinorrhea, nasal itching and sneezing TNSS. Outcome measures were difference in maximum TNSS between the four treatments and the difference in daily TNSS. | TNSS outcomes were conducted at baseline, immediately after exposure (½ + 3½ hours) and the end of exposure (5½ post exposure initiation). | No |
| Other | To assess changes in concentrations of cytokines in condensed exhaled breath. | To assess changes of concentrations of cytokines (TNF, IL-6, IL-8) in condensed exhaled breath develop in participants exposed to the fours treatments. | The samples were conducted at baseline and in the end of exposure (5½ post exposure initiation). | No |
| Primary | Causes of subjective Health effects from dust, ozone and interaction with dust and ozone as air pollutants compared to exposing with placebo filtered air. | To assess the subjective discomfort from dust and ozone. The subjective baseline and follow-up Health Measurements includes completing a computerbased symptom and comfort questionnaire. Three indexes were used: Index for Irritated Body perceptions (IBP) consisting of the individual symptoms eye irritation, throat irritation and nose irritation, Index for Lower Respiratory Effects (LRE) consisting of perceptions of cough, shortness of breath and tightness of breath and finally the Index for Weak Inflammatory Response (WIR) consisting of eye irritation, dry eyes, watering eyes, throat irritaion, nose irritaion and itching skin. | The Health outcomes were conducted at baseline, immediately after exposure (½ + 3½ hours) and the end of exposure (5½ post exposure initiation). | No |
| Secondary | To assess changes in blood biomarkers compared with exposing with placebo filtered air. | To assess the changes in blood biomarkers develop in participants exposed to the four treatments. Blood samples will be conducted by taking a venous blood sample.Blood plasma will be frozen, and following analyzed for substances related to both allergic and non-allergic immune responses, e.g.cytokines IL-4, IL-5 and TNF. | The blood samples were conducted at baseline, in the end of exposure (5½ post exposure initiation) and follow-up (24 hours) | No |
| Secondary | To assess changes in concentrations of cytokines in nasal lavage fluid. | To assess changes of concentrations of cytokines (TNF, IL-6, IL-8) in nasal lavage fluid develop in patient exposed to filtered air compared to the same patients in an exposed environment with dust and ozone. | The lavage samples were conducted at the pre-exposure and in the end of exposure (5½ post exposure initiation). | No |
| Secondary | To assess changes in the intranasal volume measured by acoustic rhinometry (AR) | The assessment will be based on the difference between minimum and maximum volume as determined by acoustic rhinometry. The minimum cross-sectional area will be calculated and the area-distance curve Integrated to determine the volumes at a distance of two to four centimetres from the nostril. | During the study day Measurements for AR will be performed at baseline, immediately following exposure and at the end of the study day (at 5½ hours from baseline) | No |
| Secondary | To assess changes in the epithelial plasticity with Endopat measures. | The EndoPAT is a medical device for noninvasive endothelial function assessment. It measures endothelium-mediated changes in vascular tone using bio-sensors placed on the fingertips. These changes in arterial tone are elicited by creating a down-stream hyperemic response induced by a standard 5-minute occlusion of the brachial artery. Measurements from the contra-lateral arm are used to control for concurrent non-endothelial dependent changes in vascular tone. The automatically calculated result is an index of endothelial function. The EndoPAT detects plethysmographic pressure changes in the finger tips caused by the arterial pulse and translates this to a peripheral arterial tone (PAT). | The EndoPat was conducted in the end of exposure (5½ post exposure initiation). | No |
| Secondary | To assess changes in Forced Expiratory Volume (FEV1) | The participants´ lung function was recorded using a Micro DL spirometer | On each study day : baseline, 30 min., 3½hour, 5½ post-exposure and in 3 hour intervals for 24 hours. | No |