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Completed

NCT Number: NCT02509000

Beijing Indoor Air Purifier Intervention Study

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.

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Key information

Conditions

Pulmonary Disease Lung Diseases Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Air purifier

Other

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

Primary outcomes

  1. respiratory inflammation

    Time frame: 4 weeks

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

Secondary outcomes

  1. systemic inflammation

    Time frame: 4 weeks

    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)

  2. oxidative stress

    Time frame: 4 weeks

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

Other outcomes

  1. lung function

    Time frame: 4 weeks

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

  2. autonomic function

    Time frame: 4 weeks

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

Sponsors and collaborators

Lead sponsor

WeiHuang

Other

Collaborators

  • Peking University Third Hospital
  • Utrecht University

Registry information

Acronym: BIAPSY

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 27, 2015
Registry last updated
Oct 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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