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NCT Number: NCT07505602

Air Purifier Use and Respiratory Health in COPD Patients

This randomized, double-blind, parallel-controlled trial aims to evaluate the effects of an indoor air purifier intervention on respiratory health in patients with Chronic Obstructive Pulmonary Disease (COPD).

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This randomized, double-blind, parallel-controlled trial will evaluate the effects of a 12-month home-based air purification intervention on respiratory health in non-smoking COPD patients in China. Participants will be randomized to receive an active or sham air purifier, with all participants and outcome assessors blinded to allocation. Health assessments, including clinical evaluation (e.g., pulmonary function tests, impulse oscillometry, and high-resolution computed tomography of the chest, etc.), questionnaire surveys (e.g., St. George's Respiratory Questionnaire and COPD Assessment Test, etc.), and biological sample collection (e.g., venous blood and urine, etc.), will be conducted at baseline and during follow-up visits at the 1st, 3rd, 6th, and 12th months. In addition, monthly telephone follow-ups will be performed to assess respiratory health status throughout the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 50 and 80 years old
  • Physician diagnosis of COPD
  • Living in Shanghai during the intervention period
  • Subjects who have no plans to change homes during the intervention period
  • Non-smokers and former smokers

Exclusion criteria

  • Subjects living in a location other than home
  • Subjects with a history of alcohol abuse
  • Subjects with other chronic lung diseases, such as active tuberculosis, pulmonary fibrosis, cystic fibrosis, or alpha-1 antitrypsin deficiency
  • Subjects with a history of thoracic surgery
  • Subjects with a history of malignant tumors, such as lung cancer, liver cancer, or gastric cancer
  • Subjects with diagnosed chronic hepatic or renal insufficiency, such as liver cirrhosis, chronic viral hepatitis, or autoimmune liver disease
  • Subjects with acute myocardial infarction or unstable arrhythmia diagnosed within the past 6 weeks
  • Subjects currently participating in other interventional studies

Treatment and study plan

Using air purifiers with high-efficiency particulate air (HEPA) and carbon filters

Behavioral

Participants in the intervention arm will receive active air purifiers, which will be installed in their bedroom and the room where they spend the most time at home. The devices will operate continuously for the entire intervention period.

Using air purifiers with non-functional filtration system

Behavioral

Participants in the intervention arm will receive sham air purifiers, which will be installed in their bedroom and the room where they spend the most time at home. The devices will operate continuously for the entire intervention period.

Primary outcomes

  1. Changes in the percentage of low attenuation area at -950 Hounsfield units (%LAA-950)

    Time frame: Baseline and after the completion of the intervention period (12 months anticipated)

    %LAA-950 was defined as the percentage of voxels with attenuation lower than -950 Hounsfield units. A higher percentage reflects more severe emphysematous destruction of lung tissue.

  2. Changes of wall area percentage (WA%)

    Time frame: Baseline and after the completion of the intervention period (12 months anticipated)

    Airway wall thickness was calculated as the mean percentage of wall area (WA%) of prespecified segmental and subsegmental bronchi from each lung lobe.

  3. Changes of forced expiratory volume in 1 s (FEV1)

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    The pulmonary function measures are performed by a professional medical device. Before the pulmonary function test, subjects practice several times with the guidance of professional staff. During the examination, each subject is in a sitting position and clamps the nose clip, and repeats the test, with the best result as the criterion.

Secondary outcomes

  1. Changes of St. George's Respiratory Questionnaire (SGRQ) score

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    The SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. The total score is from 0 to 100. Higher scores indicate more limitations

  2. Changes of COPD Assessment Test (CAT) score

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life and how this changes over time. The total score ranges from 0 to 40, with higher scores indicating a more severe impact of the disease on the patient's life.

  3. COPD exacerbations

    Time frame: Baseline and monthly thereafter through the 12th month

    Physician diagnosed exacerbation of acute COPD

Other outcomes

  1. Change of Total Lung Volume (TLV)

    Time frame: Baseline and after the completion of the intervention period (12 months anticipated)

    Measured by quantitative CT (QCT) analysis software on inspiratory chest CT. Total lung volume is calculated by summing voxels segmented as lung parenchyma, reported in milliliters (mL).

  2. Change of mean pulmonary nodule size

    Time frame: Baseline and after the completion of the intervention period (12 months anticipated)

    The average diameter of identified pulmonary nodules is measured via chest CT and evaluated by a radiologist, reported in millimeters (mm).

  3. Change of mean airway wall thickness (WT)

    Time frame: Baseline and after the completion of the intervention period (12 months anticipated)

    Measured by quantitative CT (QCT) analysis software on inspiratory chest CT. The absolute thickness of the airway wall (mm) is measured from the inner to the outer lumen boundary.

  4. Change of mean luminal area (LA)

    Time frame: Baseline and after the completion of the intervention period (12 months anticipated)

    The luminal area (mm²) of the pre-specified segmental and sub-segmental bronchi will be measured using quantitative CT analysis software.

  5. Changes of forced expiratory volume in 1 s (FEV1) / forced vital capacity (FVC) ratio

    Time frame: Baseline, and at the 1st, 3rd, 6th,and 12th months (12 months anticipated)

    The pulmonary function measures are performed by a professional medical device. Before the pulmonary function test, subjects practice several times with the guidance of professional staff. During the examination, each subject is in a sitting position and clamps the nose clip, and repeats the test, with the best result as the criterion.

  6. Changes of forced vital capacity(FVC)

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    The pulmonary function measures are performed by a professional medical device. Before the pulmonary function test, subjects practice several times with the guidance of professional staff. During the examination, each subject is in a sitting position and clamps the nose clip, and repeats the test, with the best result as the criterion.

  7. Changes of maximal mid-expiratory flow (MMEF)

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    The pulmonary function measures are performed by a professional medical device. Before the pulmonary function test, subjects practice several times with the guidance of professional staff. During the examination, each subject is in a sitting position and clamps the nose clip, and repeats the test, with the best result as the criterion

  8. Changes of maximal expiratory flow at 75% of forced vital capacity (MEF 75)

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    The pulmonary function measures are performed by a professional medical device. Before the pulmonary function test, subjects practice several times with the guidance of professional staff. During the examination, each subject is in a sitting position and clamps the nose clip, and repeats the test, with the best result as the criterion.

  9. Changes of maximal expiratory flow at 50% of forced vital capacity (MEF 50)

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    The pulmonary function measures are performed by a professional medical device. Before the pulmonary function test, subjects practice several times with the guidance of professional staff. During the examination, each subject is in a sitting position and clamps the nose clip, and repeats the test, with the best result as the criterion.

  10. Changes of maximal expiratory flow at 25% of forced vital capacity (MEF 25)

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    The pulmonary function measures are performed by a professional medical device. Before the pulmonary function test, subjects practice several times with the guidance of professional staff. During the examination, each subject is in a sitting position and clamps the nose clip, and repeats the test, with the best result as the criterion.

  11. Changes of the difference between respiratory resistance at 5 and 20 Hz (R5-R20)

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    The respiratory impedance measures are performed by a professional impulse oscillometry (IOS) device. During the examination, each subject is in a sitting position, wears a nose clip, and is instructed to maintain normal tidal breathing. Professional staff guide the subjects to support their cheeks with both hands to prevent upper airway shunting.

  12. Changes of airway resistance at 5 Hz (R5)

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    The respiratory impedance measures are performed by a professional impulse oscillometry (IOS) device. During the examination, each subject is in a sitting position, wears a nose clip, and is instructed to maintain normal tidal breathing. Professional staff guide the subjects to support their cheeks with both hands to prevent upper airway shunting.

  13. Changes of fractional exhaled nitric oxide (FeNO) levels

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    A NIOX VERO Sensor is used to measure fractional exhaled nitric oxide (FeNO), a biomarker of airway inflammation. After deep breathing, the subjects gently inhaled into the device. The instrument shows the subjects' FeNO levels.

  14. Changes of absolute eosinophil count

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    Detect the absolute count of eosinophils in peripheral blood samples to evaluate the potential response to air purification.

  15. Changes of absolute neutrophil count

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    Measure the concentration of neutrophils in blood samples to evaluate the potential response to air purification.

  16. Changes of plasma proteomic profile

    Time frame: Baseline and after the completion of the intervention period (12 months anticipated)

    Detect the concentration and expression levels of systemic proteins in blood samples to examine the differential protein signatures between the intervention and control groups.

  17. Changes of blood lipids

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    Measure the concentrations of total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) in blood samples to evaluate the potential metabolic response to air purification, particularly regarding cardiovascular risk.

  18. Changes of fasting plasma glucose

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    Measure fasting plasma glucose levels in blood samples to assess the potential impact of air purification on acute glucose metabolism.

  19. Changes of skeletal muscle mass

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    Measure skeletal muscle mass using bioelectrical impedance analysis to evaluate the potential effect of air purification on muscle preservation in COPD patients.

  20. Changes of body fat percentage

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    Measure body fat percentage using bioelectrical impedance analysis to assess the potential impact of air purification on adiposity.

  21. Changes of Apnea-Hypopnea Index (AHI)

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    AHI is a polysomnography-derived measure of sleep-disordered breathing severity, calculated as the total number of apnea and hypopnea events per hour of sleep. Higher AHI values indicate more severe sleep-disordered breathing.

  22. Changes of sleep onset latency (SOL)

    Time frame: Baseline and daily thereafter through the 12th month

    Measured nightly by a contactless ballistocardiography (BCG) sensor mat under the pillow to determine the time (minutes) from lights off to the first sleep epoch.

  23. Changes of total sleep time (TST)

    Time frame: Baseline and daily thereafter through the 12th month.

    Measured nightly by a contactless ballistocardiography (BCG) sensor mat under the pillow, summing all sleep epochs (minutes) from sleep onset to final awakening to assess the potential impact of air purification on sleep quantity.

  24. Changes of heart rate variability

    Time frame: Baseline and daily thereafter through the 12th month.

    Calculated from inter-beat intervals (J-J intervals) extracted from BCG signals recorded by the under-pillow mat; reported as root mean square of successive differences (ms) to assess the potential impact of air purification on autonomic nervous system function.

  25. Major Adverse Cardiovascular Events (MACE)

    Time frame: Baseline and monthly thereafter through the 12th month

    MACE is defined as a composite endpoint including: ischemic heart disease/coronary artery disease (I20, I24, I25), myocardial infarction (I21, I22, I23), atrial fibrillation (I48), venous thromboembolism (I74, I80, I82), heart failure (I50), and stroke (I60, I61, I62, I63, I64, I69). Events will be identified through medical records and follow-up assessments.

  26. Changes of handgrip strength

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    Measure the maximum grip strength (in kilograms) using a hand dynamometer to evaluate the potential effect of air purification on muscle strength and functional status in COPD patients.

  27. Changes of blood pressure

    Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)

    Measure systolic and diastolic blood pressure (in mmHg) using a validated electronic sphygmomanometer to evaluate the potential effect of air purification on hemodynamic function.

Study contacts

Contact information is provided by the study sponsor or research team.

Haidong Kan, Ph.D

CONTACT

[email protected]

+86-021-54237908

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Respiratory Benefits of Indoor Air Purification in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2026
Registry last updated
Jun 9, 2026

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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