NCT03319056

Brief Summary

The objective of this study is to investigate the cardiopulmonary health effects of indoor air purification and different indoor environmental factors among school students in Beijing.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 11, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

October 18, 2017

Last Update Submit

May 21, 2019

Conditions

Cardiopulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Levels of lung function indicators

    Lung function test was conducted including forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF).

    10 weekdays for intervention (active or sham) and 2 wash-out months

Secondary Outcomes (5)

  • Changes in autonomic cardiac function

    10 weekdays for intervention (active or sham) and 2 wash-out months

  • Level of respiratory inflammation

    10 weekdays for intervention (active or sham) and 2 wash-out months

  • Changes in ST-segment elevation

    10 weekdays for intervention (active or sham) and 2 wash-out months

  • Levels of oxidative stress in Exhaled Breath Condensate (EBC)

    10 weekdays for intervention (active or sham) and 2 wash-out months

  • Levels of urinary metabolomics

    10 weekdays for intervention (active or sham) and 2 wash-out months

Study Arms (2)

Real purification

ACTIVE COMPARATOR

Air purifier turned on

Other: Air purifier

Sham purification

SHAM COMPARATOR

Air purifier turned off

Other: Air purifier

Interventions

Air purifierOTHER

active- or sham-mode air purifier used in 6 classrooms in a school with a crossover design

Real purificationSham purification

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • living in Beijing for more than two consecutive years;
  • living in school dormitories from Monday to Friday.

You may not qualify if:

  • suffering any health condition;
  • having asthma or thoracic surgery history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Pubic Health, Peking University

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Pulmonary Heart Disease

Interventions

Air Filters

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

FiltrationChemistry Techniques, AnalyticalInvestigative TechniquesEquipment and Supplies

Study Officials

  • Furong Deng, PhD&MD

    Peking 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 & PhD, Professor, Deputy Director of Department of Occupational & Environmental Health Sciences

Study Record Dates

First Submitted

October 18, 2017

First Posted

October 24, 2017

Study Start

December 11, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

May 23, 2019

Record last verified: 2019-05

Locations

CN(1)