Beijing Indoor Air Purifier Intervention Study

Pulmonary Disease Clinical Trial

— BIAPSY  

Official title:

Beijing Indoor Air Purifier Intervention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02509000
• Other study ID #: WHuang14
• Status: Completed
• Phase: N/A
• First received: July 20, 2015
• Last updated: October 20, 2015
• Start date: December 2013
• Est. completion date: November 2014

Study information

• Verified date: July 2015
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Pulmonary Disease

Intervention

Other:
• air purifier
filtration units randomly allocated to active- and sham-mode in 20 recruited households for four weeks

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
WeiHuang	Peking University Third Hospital, Utrecht University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	lung function	lung function test (FEV1, FEV1 %predicted, FEV1/FVC, 176 maximum midexpiratory flow (MMEF), MMEF %predicted) using an Aspirometer	4 weeks	No
Other	autonomic function	twelve-hour ambulatory electrocardiogram (ECG) and blood pressure (BP) were monitored	4 weeks	No
Primary	respiratory inflammation	analyzed EBC pH and inflammation biomarkers 8-isoprostane and nitrite and nitrate	4 weeks	No
Secondary	systemic inflammation	analyzed systemic inflammation biomarkers C-reaction Protein, Blood coagulation factor fibrinogen (Fib), Interleukin (IL) -8, -1ß, -6, -10, -12p70 and tumor necrosis factor-a (TNF-a)	4 weeks	No
Secondary	oxidative stress	analyzed systemic oxidative stress biomarker urinary 8-hydroxy-2-deoxyguanosine (8-OHdG)	4 weeks	No