Beijing Indoor Air Purifier Intervention Study (BIAPSY)

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease
• Intervention / Treatment: Other: air purifier

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active-mode; Air purifier in active-mode	Other: air purifier; filtration units randomly allocated to active- and sham-mode in 20 recruited households for four weeks
Sham Comparator: Sham-mode; Air purifier in sham-mode	Other: air purifier; filtration units randomly allocated to active- and sham-mode in 20 recruited households for four weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
respiratory inflammation	analyzed EBC pH and inflammation biomarkers 8-isoprostane and nitrite and nitrate	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	4 weeks
oxidative stress	analyzed systemic oxidative stress biomarker urinary 8-hydroxy-2-deoxyguanosine (8-OHdG)	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
lung function	lung function test (FEV1, FEV1 %predicted, FEV1/FVC, 176 maximum midexpiratory flow (MMEF), MMEF %predicted) using an Aspirometer	4 weeks
autonomic function	twelve-hour ambulatory electrocardiogram (ECG) and blood pressure (BP) were monitored	4 weeks

Collaborators and Investigators

• Sponsor: WeiHuang
• Collaborators: Peking University Third Hospital; Utrecht University
• Investigators: Principal Investigator: Wei Huang, PhD, Peking University School of Public Health

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: July 20, 2015
• First Submitted That Met QC Criteria: July 23, 2015
• First Posted (Estimate): July 27, 2015

Study Record Updates

• Last Update Posted (Estimate): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 20, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: WHuang14