Intervention Study on the Health Effects of Wearing Particulate Filtering Respirators

Inflammation Clinical Trial

Official title:

The Health Effects of Wearing Particulate Filtering Respirators in Healthy Adults in China-an Intervention Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02238028
• Other study ID #: KZGY 001
• Status: Not yet recruiting
• Phase: N/A
• First received: September 7, 2014
• Last updated: September 11, 2014
• Start date: November 2014
• Est. completion date: January 2015

Study information

• Verified date: September 2014
• Source: Fudan University
• Contact: zhao zhuohui, A.P.
• Phone: +86-21-54237343
• Email: zhzhao[@]fudan.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

An intervention study to assess the cardiovascular and respiratory effects of reducing personal air pollution exposure by wearing particulate filtering respirators.

Description:

A group of healthy subjects fulfilling the recruitment criteria will be randomly grouped into two groups. The first group wearing the specific particulate filtering respirators for the required time period both indoor and outdoor except the necessary needs during daily life to get rid of it. The other group act as usual but with the same air pollution exposure and health effects monitoring. After at least 2 weeks since the end of the first intervention, the second intervention was initiated with exchange the roles of wearing or not wearing the particulate filtering respirators.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Equal to or older than 18 years old,

• No history of smoking and alcohol addiction.

• No chronic diseases,such as hypertension,diabetes,chronic obstructive pulmonary disease or other respiratory/cardiovascular diseases reported by volunteers.

• No respiratory or allergic diseases, like asthma, rhinitis,or other allergic diseases.

Exclusion Criteria:

• Current smokers

• Chronic drug use due on cardiovascular or respiratory diseases

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asymptomatic Condition
• Asymptomatic Diseases
• Blood Pressure
• Inflammation

Intervention

Other:
• Particulate filtering respirator
particulate filtering respirators are required to wear for continuous 48 hours except the necessary daily life needs to get rid of it. Each subject will act the control of himself/herself since they all need to accomplish wearing the particulate filtering respirator or not wearing.

Locations

Country	Name	City	State
China	Department of Environmental Health, School of Public Health, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Haidong Kan

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	saliva biomarker		2 hours within the end of intervention	No
Other	Microvascular function		3 hours within the end of the intervention	No
Other	saliva stress biomarkers	The Saliva samples are collected within 3 hours within the end of intervention, and immediately stored in -80 degrees centigrade until analyses which are completed within 3 months of the end of intervention.	3 months within the end of intervention	No
Primary	Heart rate variability	Subjects were attached with Holter monitor at the beginning of the study for 24 hours. Heart rate and related heart automatic function indices were automatically recorded during the the intervention	up to 24 hours	No
Secondary	Blood pressure	The blood pressure were measured by an automatic blood pressure monitor during the intervention study.	up to 24 hours	No
Secondary	Fractional exhaled nitric oxide(FENO)	An online measurement was applied for FeNO levels.	3 hours within the end of the intervention	No
Secondary	Lung function	Lung function tests including forced expiratory volume at one second ,forced expiratory volume and maximal expiratory flow are monitored by professional clinical doctors by using validated instrument.	3 hours within the end of intervention	No
Secondary	Blood biomarkers	Blood samples of subjects will be collected at the end of each intervention by a trained nurse,and separated within 30 minutes by centrifugation. Then the blood samples were transported directly to laboratory and stored at -80 degrees centigrade until later analyses.Then blood inflammation factors and blood clotting factors will be detected within 3 months of sample collection.	3 months (plus or minus 2 weeks)within the end of intervention	No