Effect of Short-term Portable Air Purifier Use on Occupant Health Indicators

NCT02736487 | Completed

• 1 other identifier: 2015[38]
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research project is to examine whether short-term use of portable air pollution filtration can result in changes in indoor airborne pollutants and impact on cardiovascular and respiratory health outcomes of the inhabitants.

Conditions

Non-smoking, Healthy Adults

Keywords

Air Pollution; Exposure Assessment; Filtration; Cardiovascular Outcomes; Respiratory Outcomes; Short-term Intervention

Outcome Measures

Primary Outcomes (5)

• Change from baseline FEV1 (forced expiratory volume in the first second of exhalation) within 2h after the filtration intervention

  FEV1 (forced expiratory volume in the first second of exhalation, unit: liter) was measured by spirometry in all subjects within 2h after the filtration intervention to compare to FEV1 value of study subjects at baseline (i.e. at start of the study).

  Within 2h after the filtration intervention

• Change from baseline R5 (airway resistance measured at 5Hz) within 2h after the filtration intervention

  R5 (airway resistance measured at 5Hz) was accessed by impulse oscillometry in all subjects within 2h after the filtration intervention to compare to the R5 value of study subjects at baseline (i.e. before the start of intervention).

  Within 2h after the filtration intervention

• Change in baseline exhaled nitric oxide (eNO) within 2h after the filtration intervention

  Exhaled nitric oxide (eNO) was measured in all subjects within 2h after the filtration intervention to compare to the exhaled nitric oxide measurement of study subjects at baseline (i.e. before the start of intervention). Exhaled breath is collected in air sampling bags, and the concentration of NO was quantified by Thermo Scientific model 42i (NO-NO2-NOx) analyzer.

  Within 2h after the filtration intervention

• Change in exhaled nitric oxide (eNO) at 6h after filtration intervention compared to baseline

  Exhaled nitric oxide (eNO) was measured in all subjects 6h after filtration intervention to compare to the exhaled nitric oxide measurement of study subjects at baseline (i.e. before the start of intervention). Exhaled breath is collected in air sampling bags, and the concentration of NO was quantified by Thermo Scientific model 42i (NO-NO2-NOx) analyzer.

  6h after filtration intervention

• Change from baseline PWV (pulse wave velocity) within 2h after the filtration intervention

  PWV (pulse wave velocity) was measured by the VICORDER instrument in all subjects right after filtration intervention to compare to the PWV value measured at baseline (i.e. before the start of intervention).

  Within 2h after the filtration intervention

Secondary Outcomes (6)

• Change from baseline urinary biomarkers of inflammation and oxidative stress at 0h after the filtration intervention

  At 0h after the filtration intervention

• Change in baseline urinary biomarkers of inflammation and oxidative stress at 6h after filtration intervention

  6h after filtration intervention

• Change in baseline urinary biomarkers of inflammation and oxidative stress at 24h after filtration intervention

  24h after filtration intervention

• Changes in baseline blood biomarkers of inflammation, oxidative stress and coagulation within 1h after filtration intervention

  Within 1h after filtration intervention

• Changes in baseline blood biomarkers of inflammation, oxidative stress and coagulation right after filtration intervention

  24h after filtration intervention

Study Arms (2)

Group A: True-Washout-Sham

ACTIVE COMPARATOR

Subjects in group A receives true air filtration intervention, then at least two weeks of washout period, followed by sham air filtration intervention.

Device: True-Washout-Sham Air Filtration Intervention

Group B: Sham-Washout-True

ACTIVE COMPARATOR

Subjects in group B receives sham air filtration intervention, then at least two weeks of washout period, followed by true air filtration intervention.

Device: Sham-Washout-True Air Filtration Intervention

Interventions

True-Washout-Sham Air Filtration Intervention DEVICE

This intervention involved three sequential steps: (1) 12 to 20 hours of true air filtration intervention; (2) at least two weeks of washout period; (3) 12 to 20 hours of sham air filtration intervention. In the indoor environment, the portable filtration device drew room air, sent it through filter and active carbon (for true filtration) or active carbon alone (sham filtration) and then delivered processed air back to room air. In the study the portable filtration device processes 2.8 cubic meter of room air per minute. The washout period lasted for at least two weeks where no filtration intervention was implemented.

Group A: True-Washout-Sham

Sham-Washout-True Air Filtration Intervention DEVICE

This intervention involved three sequential steps: (1) 12 to 20 hours of sham air filtration intervention; (2) at least two weeks of washout period; (3) 12 to 20 hours of true air filtration intervention. In the indoor environment, the portable filtration device drew room air, sent it through filter and active carbon (for true filtration) or active carbon alone (sham filtration) and then delivered processed air back to room air. In the study the portable filtration device processes 2.8 cubic meter of room air per minute. The washout period lasted for at least two weeks where no filtration intervention was implemented.

Group B: Sham-Washout-True

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, non-smoking adults
• Live in the dormitory building at Shanghai First People's Hospital (South Section).

You may not qualify if:

• Current smokers
• Has any of the following diseases: chronic respiratory, cardiovascular, liver, renal, hematological disease; diabetes mellitus;
• Has any other diseases that may confound or complicate the effects of the intervention
• Pregnant females

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Duke University: collaborator
• Tsinghua University: collaborator
• Rutgers University: collaborator

Study Sites (1)

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 201620, China

Location

Study Officials

• Junfeng Zhang, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Yinping Zhang, PhD

  Tsinghua University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: April 13, 2016
• Study Start: November 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 13, 2016

Record last verified: 2016-03

Locations

CN (1)