School of Public Health, Fudan University
Shanghai, China
Location status: Recruiting
NCT Number: NCT07505602
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).
Interested in participating?
Request Info50 year–80 year
All sexes
Interventional
Not applicable
Shanghai, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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
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.
Time frame: Baseline and monthly thereafter through the 12th month
Physician diagnosed exacerbation of acute COPD
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).
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).
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Fudan University
Other
Respiratory Benefits of Indoor Air Purification in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
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