Respiratory Health
Conditions
Keywords
Chronic Obstructive Pulmonary Disease, Air purifier, Randomized controlled trial, Respiratory health
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALUsing air purifiers with high-efficiency particulate air (HEPA) and carbon filters
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.
BEHAVIORALUsing air purifiers with non-functional filtration system
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.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the percentage of low attenuation area at -950 Hounsfield units (%LAA-950) | 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. |
| Changes of wall area percentage (WA%) | 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. |
| Changes of forced expiratory volume in 1 s (FEV1) | 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
| Measure | Time frame | Description |
|---|---|---|
| Changes of St. George's Respiratory Questionnaire (SGRQ) score | 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 |
| Changes of COPD Assessment Test (CAT) score | 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. |
| COPD exacerbations | Baseline and monthly thereafter through the 12th month | Physician diagnosed exacerbation of acute COPD |
Countries
China
Contacts
CONTACTHaidong Kan, Ph.D
Outcome results
None listed