Clinical trial NCT02239744: Intervention Study on the Health Impact of Air Filters in Chinese Adults
Official title: Cardiopulmonary Benefits of Reducing Indoor Particles of Outdoor Origin: a Randomized Double-blind Crossover Trial of Air Purifiers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Coagulation
Blood Pressure
Pulmonary Function
Keywords: air pollution
air purification
intervention
randomized controlled trial
cardiovascular health
pulmonary health
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2014-09-15
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study aimed to evaluate whether a short-term indoor air purifier intervention improves cardiopulmonary health based on a randomized double-blind crossover trial

Detailed description: We conducted a randomized double-blind crossover trial among 35 healthy college students in Shanghai, China in 2014. These students lived in dormitories that were randomized into two groups and alternated the use of true or sham air purifiers for 48 hours with a 2-week wash-out interval.All participants and research staff were blinded to the group assignment. We requested all participants to stay in their dormitory room with the windows/doors closed throughout each 48-hour intervention period. We delivered foods and drinks to each room during the intervention period. All interventions started at 8 a.m. to avoid issues related to diurnal variation. We evaluated health endpoints and drew blood immediately after the completion of each 48-hour intervention. We measured 14 circulating biomarkers of inflammation, coagulation and vasoconstriction, lung function, blood pressure (BP), and fractional exhaled nitric oxide (FeNO).

Eligibility criteria: Inclusion Criteria:

* Healthy college students aged between 18 and 26
* All the subjects should stay indoor almost the entire time, and stayed within the central urban area of shanghai during the wash-out period.

Exclusion Criteria:

* current smokers or ever smokers
* chronic respiratory diseases
* chronic cardiovascular diseases
* acute infections
* medication use in recent one month

Primary outcomes:
measure: Circulating Biomarkers
timeFrame: Blood samples were drawn within one hour after the intervention, and lab analysis was completed in the next 10 days
measure: Lung Function
timeFrame: Within 1 hour after the end of the two-day intervention
Secondary outcomes:
measure: Blood Pressure
timeFrame: Within one hour after the 2-day intervention
measure: Fractional Exhaled Nitric Oxide
timeFrame: within 1 hour after the two-day intervention
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Environmental Health, School of Public Health, Fudan University
state: Shanghai
Study officials:
affiliation: School of Public Health，Fudan University
name: Haidong Kan, PhD
role: STUDY_DIRECTOR
References:
citation: Chen R, Zhao A, Chen H, Zhao Z, Cai J, Wang C, Yang C, Li H, Xu X, Ha S, Li T, Kan H. Cardiopulmonary benefits of reducing indoor particles of outdoor origin: a randomized, double-blind crossover trial of air purifiers. J Am Coll Cardiol. 2015 Jun 2;65(21):2279-87. doi: 10.1016/j.jacc.2015.03.553.