NCT02509000

Brief Summary

This study aimed to assess the impact of air filtration on indoor air quality and cardio-pulmonary health in residents living in high outdoor pollution settings in Beijing.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2013

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

Study Start

First participant enrolled

December 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2015

Completed
Last Updated

October 21, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

July 20, 2015

Last Update Submit

October 20, 2015

Conditions

Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • respiratory inflammation

    analyzed EBC pH and inflammation biomarkers 8-isoprostane and nitrite and nitrate

    4 weeks

Secondary Outcomes (2)

  • systemic inflammation

    4 weeks

  • oxidative stress

    4 weeks

Other Outcomes (2)

  • lung function

    4 weeks

  • autonomic function

    4 weeks

Study Arms (2)

Active-mode

ACTIVE COMPARATOR

Air purifier in active-mode

Other: air purifier

Sham-mode

SHAM COMPARATOR

Air purifier in sham-mode

Other: air purifier

Interventions

air purifierOTHER

filtration units randomly allocated to active- and sham-mode in 20 recruited households for four weeks

Active-modeSham-mode

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Global Initiative for Chronic Obstructive Lung Disease criteria (mild to moderate, GOLD stage I\~II;
  • severe to very severe, GOLD stage III\~IV) quit smoking for at least 1 year;
  • a ratio of pre-bronchodilator forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) equal to or less than 0.70 and an increase of FEV1 with the use of 400μg of albuterol of less than 12% of the pre-bronchodilator one;
  • no history of asthma or any other active lung disease.
  • Subjects were free from exacerbations for at least 6 weeks.

You may not qualify if:

  • Patients with heart pacemaker,
  • heart failure with bundle-branch block,
  • recent myocardial infarction (in the last 12 weeks) and
  • anticoagulant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Diseases

Interventions

Air Filters

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

FiltrationChemistry Techniques, AnalyticalInvestigative TechniquesEquipment and Supplies

Study Officials

  • Wei Huang, PhD

    Peking University School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Peking University School of Public Health

Study Record Dates

First Submitted

July 20, 2015

First Posted

July 27, 2015

Study Start

December 1, 2013

Primary Completion

March 1, 2014

Study Completion

November 1, 2014

Last Updated

October 21, 2015

Record last verified: 2015-07