The Use of Air Cleaners to Mitigate Cardiopulmonary Health Impact of Indoor Exposure to Particles and Phthalates

P

Peking University

Status

Completed

Conditions

Inflammation
Oxidative Stress
Lung Function
Blood Pressure

Treatments

Behavioral: Air cleaner use method 2
Behavioral: Air cleaner use method 1

Study type

Interventional

Funder types

Other

Identifiers

NCT03500614
2016YFC0207103 (Other Grant/Funding Number)
2017095
2017YFC0211601 (Other Grant/Funding Number)

Details and patient eligibility

About

This study aims to evaluate whether a short-term intervention strategy using air cleaner reduces indoor exposure to airborne particles (particulate matter with an aerodynamic diameter ≤2.5μm, PM2.5) and phthalates and improves cardiopulmonary health among Chinese healthy adults based on a randomized double-blinded crossover trial.

Full description

The randomized double-blind crossover trial includes two cohorts with different intervention and health examination settings and will be conducted in Beijing, China between November 2017-May 2018. The first cohort plans to include 70 healthy college students who live in school dormitories, which were randomized into two dormitory groups to receive either true or sham air cleaner treatment for 1 week and then alternate the treatment after a wash out interval of at least 2 weeks (But in the enrollment, only 57 students were recruited actually). All participants and research staff are blinded to the group assignment. All participants are encouraged to stay in the dormitory with windows/doors tightly closed throughout the 1-week treatment period as far as possible, whereas necessary outdoor activities such as attending classes and dining in school canteens are allowed. All interventions will start at noon on Tuesday or Thursday and continue to the next morning of Tuesday or Thursday to avoid issues related to diurnal variation. Real-time PM2.5 concentrations will be measured using portable monitors and airborne PM2.5 mass samples will be collected in air filters throughout the treatment period. Air and fine particle phase phthalates samples will be collected using glass sampling tube filled with XAD2 macroporous resin and PM2.5 air filters respectively during the last day (24 hours) of the treatment period. Health variables, including blood pressure, lung function, fractional exhaled nitric oxide (FeNO), will be evaluated and biological samples including morning urine and fasting blood will be collected immediately after the completion of each treatment period. Efficacy of air cleaner treatment to reduce indoor exposure to particles and phthalates and related improvements in cardiopulmonary health variables will be evaluated using professional statistical methods. The second cohort plans to include 30 healthy college students who will undergo extended treatment period covering the start, peak and end phases of smog episodes occurring in Beijing (To avoid dropout, 32 students were initially recruited). All interventions will start from the beginning to the end of typical smog episodes. PM2.5 exposure monitoring as detailed above will be performed throughout the treatment period and repeated health examinations will be conducted at time points corresponding to the start, peak and end phases of the smog episodes. Efficacy of air cleaner treatment to reduce indoor exposure to PM2.5 and related improvements in cardiopulmonary health variables throughout the smog episodes will be evaluated using professional statistical methods.

Enrollment

57 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy college students aged between 18 and 30 years old;
  • Will stay within the central urban area of Beijing over the entire study including the wash-out period;
  • BMI <30 kg/m3.

Exclusion criteria

  • Current or ever smokers;
  • A history of chronic respiratory diseases;
  • A history of chronic cardiovascular diseases;
  • Acute infections;
  • Medication use in recent one month;
  • Leave Beijing during the intervention.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

57 participants in 2 patient groups

Cohort 1
Experimental group
Description:
Participants (n=57) will receive either true or sham air cleaner treatment for 1 week and then alternate the treatment after a wash out interval (Air cleaner use method 1). Exposure monitoring for PM2.5 will continue throughout the treatment period and air and fine particle phase phthalates samples will be collected during the last day (24 hours) of the treatment period; and health variables will be measured and biological samples will be collected immediately after the completion of each intervention period.
Treatment:
Behavioral: Air cleaner use method 1
Cohort 2
Experimental group
Description:
Participants (n=32) will undergo extended treatment period covering the start, peak and end phases of smog episodes in Beijing, with either true or sham air cleaner treatment and then alternate the treatment after a wash out interval (Air cleaner use method 2). Exposure monitoring for PM2.5 will continue throughout the treatment period and repeated health examinations will be conducted at time points corresponding to the start, peak and end phases of the smog episodes.
Treatment:
Behavioral: Air cleaner use method 2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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