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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active air purifier group | Experimental | Participants in this group received a home-based air purifier equipped with high-efficiency particulate air (HEPA) and carbon filters. |
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| Sham air purifier group | Sham Comparator | Participants in this group received an air purifier identical in appearance to those used by the active air purifier group, but without the filtration function. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the percentage of low attenuation area at -950 Hounsfield units (%LAA-950) | %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. | Baseline and after the completion of the intervention period (12 months anticipated) |
| Changes of wall area percentage (WA%) | Airway wall thickness was calculated as the mean percentage of wall area (WA%) of prespecified segmental and subsegmental bronchi from each lung lobe. | Baseline and after the completion of the intervention period (12 months anticipated) |
| Changes of forced expiratory volume in 1 s (FEV1) | 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. | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of St. George's Respiratory Questionnaire (SGRQ) score | 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 | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Total Lung Volume (TLV) | 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). | Baseline and after the completion of the intervention period (12 months anticipated) |
| Change of mean pulmonary nodule size |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haidong Kan, Ph.D | Contact | +86-021-54237908 | kanh@fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Public Health, Fudan University | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 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. |
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| Changes of COPD Assessment Test (CAT) score | 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. | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| COPD exacerbations | Physician diagnosed exacerbation of acute COPD | Baseline and monthly thereafter through the 12th month |
The average diameter of identified pulmonary nodules is measured via chest CT and evaluated by a radiologist, reported in millimeters (mm). |
| Baseline and after the completion of the intervention period (12 months anticipated) |
| Change of mean airway wall thickness (WT) | 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. | Baseline and after the completion of the intervention period (12 months anticipated) |
| Change of mean luminal area (LA) | The luminal area (mm²) of the pre-specified segmental and sub-segmental bronchi will be measured using quantitative CT analysis software. | Baseline and after the completion of the intervention period (12 months anticipated) |
| Changes of forced expiratory volume in 1 s (FEV1) / forced vital capacity (FVC) ratio | 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. | Baseline, and at the 1st, 3rd, 6th,and 12th months (12 months anticipated) |
| Changes of forced vital capacity(FVC) | 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. | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| Changes of maximal mid-expiratory flow (MMEF) | 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 | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| Changes of maximal expiratory flow at 75% of forced vital capacity (MEF 75) | 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. | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| Changes of maximal expiratory flow at 50% of forced vital capacity (MEF 50) | 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. | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| Changes of maximal expiratory flow at 25% of forced vital capacity (MEF 25) | 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. | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| Changes of the difference between respiratory resistance at 5 and 20 Hz (R5-R20) | 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. | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| Changes of airway resistance at 5 Hz (R5) | 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. | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| Changes of fractional exhaled nitric oxide (FeNO) levels | 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. | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| Changes of absolute eosinophil count | Detect the absolute count of eosinophils in peripheral blood samples to evaluate the potential response to air purification. | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| Changes of absolute neutrophil count | Measure the concentration of neutrophils in blood samples to evaluate the potential response to air purification. | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| Changes of plasma proteomic profile | Detect the concentration and expression levels of systemic proteins in blood samples to examine the differential protein signatures between the intervention and control groups. | Baseline and after the completion of the intervention period (12 months anticipated) |
| Changes of blood lipids | 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. | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| Changes of fasting plasma glucose | Measure fasting plasma glucose levels in blood samples to assess the potential impact of air purification on acute glucose metabolism. | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| Changes of skeletal muscle mass | Measure skeletal muscle mass using bioelectrical impedance analysis to evaluate the potential effect of air purification on muscle preservation in COPD patients. | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| Changes of body fat percentage | Measure body fat percentage using bioelectrical impedance analysis to assess the potential impact of air purification on adiposity. | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| Changes of Apnea-Hypopnea Index (AHI) | 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. | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| Changes of sleep onset latency (SOL) | 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. | Baseline and daily thereafter through the 12th month |
| Changes of total sleep time (TST) | 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. | Baseline and daily thereafter through the 12th month. |
| Changes of heart rate variability | 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. | Baseline and daily thereafter through the 12th month. |
| Major Adverse Cardiovascular Events (MACE) | 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. | Baseline and monthly thereafter through the 12th month |
| Changes of handgrip strength | 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. | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| Changes of blood pressure | Measure systolic and diastolic blood pressure (in mmHg) using a validated electronic sphygmomanometer to evaluate the potential effect of air purification on hemodynamic function. | Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated) |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |