Respiratory HealthNCT07505602
Air Purifier Use and Respiratory Health in COPD Patients
A study testing Using air purifiers with high-efficiency particulate air (HEPA) and carbon filters and Using air purifiers with non-functional filtration system in people with Respiratory Health, run by Fudan University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Respiratory Health
- What is being tested?
- Using air purifiers with high-efficiency particulate air (HEPA) and carbon filters and Using air purifiers with non-functional filtration system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
School of Public Health, Fudan University
Shanghai
Haidong Kan, Ph.D, +86-021-54237908, kanh@fudan.edu.cn
About this study
Official title: Respiratory Benefits of Indoor Air Purification in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled 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).
Read the 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.
- Conditions
- Respiratory Health
- Being tested
- Using air purifiers with high-efficiency particulate air (HEPA) and carbon filters, Using air purifiers with non-functional filtration system
- Keywords
- Chronic Obstructive Pulmonary Disease, Air purifier, Randomized controlled trial, Respiratory health
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using air purifiers with high-efficiency particulate air (HEPA) and carbon filtersBehavioural
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 systemBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Using air purifiers with high-efficiency particulate air (HEPA) and carbon filters |
| 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. Receives: Behavioral: Using air purifiers with non-functional filtration system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)
Secondary outcomes (3)
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
Measured: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)
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.
Measured: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)
COPD exacerbations
Physician diagnosed exacerbation of acute COPD
Measured: Baseline and monthly thereafter through the 12th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start30 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory HealthStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haidong Kan, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505602
- Sponsor's protocol ID
- FDUEH-11
- Status last verified
- Jun 2026
- First submitted
- 20 Mar 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Benefits of Indoor Air Purification in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07505602
- Acronym / sponsor ID
- FDUEH-11
- Conditions
- Respiratory Health
- Keywords
- Chronic Obstructive Pulmonary Disease, Air purifier, Randomized controlled trial, Respiratory health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active air purifier group | Experimental | Behavioral: Using air purifiers with high-efficiency particulate air (HEPA) and carbon filtersParticipants in this group received a home-based air purifier equipped with high-efficiency particulate air (HEPA) and carbon filters. |
| Sham air purifier group | Sham comparator | Behavioral: Using air purifiers with non-functional filtration systemParticipants in this group received an air purifier identical in appearance to those used by the active air purifier group, but without the filtration function. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using air purifiers with high-efficiency particulate air (HEPA) and carbon filtersParticipants 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. | Behavioural | Active air purifier group |
| Using air purifiers with non-functional filtration systemParticipants 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. | Behavioural | Sham air purifier group |
Primary outcome
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.
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.
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.
3 secondary outcomes
Changes of St. George's Respiratory Questionnaire (SGRQ) score
Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)
Changes of COPD Assessment Test (CAT) score
Time frame: Baseline, and at the 1st, 3rd, 6th, and 12th months (12 months anticipated)
COPD exacerbations
Time frame: Baseline and monthly thereafter through the 12th month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using air purifiers with high-efficiency particulate air (HEPA) and carbon filters and Using air purifiers with non-functional filtration system in people with Respiratory Health, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haidong Kan, Ph.D (+86-021-54237908, kanh@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.