Air Purifier Use and Respiratory Health in COPD Patients
ConditionRespiratory Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorFudan University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Using air purifiers with high-efficiency particulate air (HEPA) and carbon filters
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Active air purifier groupExperimental treatment 1 intervention
Group B: Sham air purifier groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and after the completion of the intervention period (12 months anticipated)2
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.
Time frame
Baseline and after the completion of the intervention period (12 months anticipated)3
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.
Time frame
Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)Secondary outcomes
1
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
Time frame
Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)2
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.
Time frame
Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)3
COPD exacerbations
Physician diagnosed exacerbation of acute COPD
Time frame
Baseline and monthly thereafter through the 12th monthOther outcomes
1
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).
Time frame
Baseline and after the completion of the intervention period (12 months anticipated)2
Change of mean pulmonary nodule size
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)3
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.
Time frame
Baseline and after the completion of the intervention period (12 months anticipated)4
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.
Time frame
Baseline and after the completion of the intervention period (12 months anticipated)Sponsors and contacts
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Source ClinicalTrials.gov