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Beijing Indoor Air Purifier Intervention Study (BIAPSY)

Primary Purpose

Pulmonary Disease

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

air purifier

About this trial

This is an interventional health services research trial for Pulmonary Disease

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active-mode

Sham-mode

Arm Description

Air purifier in active-mode

Air purifier in sham-mode

Outcomes

Primary Outcome Measures

respiratory inflammation

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

Secondary Outcome Measures

systemic inflammation

analyzed systemic inflammation biomarkers C-reaction Protein, Blood coagulation factor fibrinogen (Fib), Interleukin (IL) -8, -1β, -6, -10, -12p70 and tumor necrosis factor-α (TNF-α)

oxidative stress

analyzed systemic oxidative stress biomarker urinary 8-hydroxy-2-deoxyguanosine (8-OHdG)

Full Information

NCT ID

NCT02509000

First Posted

July 20, 2015

Last Updated

October 20, 2015

Sponsor

WeiHuang

Collaborators

Peking University Third Hospital, Utrecht University

1. Study Identification

Unique Protocol Identification Number

NCT02509000

Brief Title

Beijing Indoor Air Purifier Intervention Study

Acronym

BIAPSY

Official Title

Beijing Indoor Air Purifier Intervention Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

March 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

WeiHuang

Collaborators

Peking University Third Hospital, Utrecht University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active-mode

Arm Type

Active Comparator

Arm Description

Air purifier in active-mode

Arm Title

Sham-mode

Arm Type

Sham Comparator

Arm Description

Air purifier in sham-mode

Intervention Type

Other

Intervention Name(s)

air purifier

Intervention Description

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

Primary Outcome Measure Information:

Title

respiratory inflammation

Description

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

systemic inflammation

Description

analyzed systemic inflammation biomarkers C-reaction Protein, Blood coagulation factor fibrinogen (Fib), Interleukin (IL) -8, -1β, -6, -10, -12p70 and tumor necrosis factor-α (TNF-α)

Time Frame

4 weeks

Title

oxidative stress

Description

analyzed systemic oxidative stress biomarker urinary 8-hydroxy-2-deoxyguanosine (8-OHdG)

Time Frame

4 weeks

Other Pre-specified Outcome Measures:

Title

lung function

Description

lung function test (FEV1, FEV1 %predicted, FEV1/FVC, 176 maximum midexpiratory flow (MMEF), MMEF %predicted) using an Aspirometer

Time Frame

4 weeks

Title

autonomic function

Description

twelve-hour ambulatory electrocardiogram (ECG) and blood pressure (BP) were monitored

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Patients with heart pacemaker, heart failure with bundle-branch block, recent myocardial infarction (in the last 12 weeks) and anticoagulant therapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Huang, PhD

Organizational Affiliation

Peking University School of Public Health

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Beijing Indoor Air Purifier Intervention Study

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