Asthma (Diagnosis)NCT07069907
The Improvement of Indoor Air and Health Effects After Air Purifier Intervention Among Susceptible Population in Industrial Area
A study testing Air purfiers with photocatalytic oxidation (PCO) and Air purfiers with photocatalytic oxidation (PCO) + filters in people with Asthma (Diagnosis) and COPD (Chronic Obstructive Pulmonary Disease), run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Invesitigators conducted a double-blind, randomized, and crossover study to investigate the effects of PCO and PCO + filters interventions on indoor air pollutants in households and health outcomes in susceptible group, such as asthma and COPD patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Asthma (Diagnosis), COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Air purfiers with photocatalytic oxidation (PCO) and Air purfiers with photocatalytic oxidation (PCO) + filters
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Jun 2022to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dianosed with asthma/COPD
Who cannot join
- did not diagonse with asthma /COPD
Trial locations and contacts
1 site in 1 country.
About this study
Invesitigators conducted a double-blind, randomized, and crossover study to investigate the effects of PCO and PCO + filters interventions on indoor air pollutants in households and health outcomes in susceptible group, such as asthma and COPD patients.
Read the detailed description
Invesitigators measured indoor air pollutants, including particulate matter, bioaerosols, gaseous pollutants, in households and health outcomes, including lung function, respiratory symptoms, fractional exhaled nitric oxide, blood pressure, biomarkers, urinary heavy metals, and polycyclic aromatic hydrocarbons, in susceptible group, such as asthma and COPD patients.
- Being tested
- Air purfiers with photocatalytic oxidation (PCO), Air purfiers with photocatalytic oxidation (PCO) + filters
- Medical subject headings
- Asthma, Disease, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air purfiers with photocatalytic oxidation (PCO)Other
PCO was proved to decompose gaseous pollutants in chamber studies, while there is no study investigate the effects in real-world. We used PCO air purifiers in households for two weeks.
Air purfiers with photocatalytic oxidation (PCO) + filtersOther
PCO was proved to decompose gaseous pollutants in chamber studies, while there is no study investigate the effects in real-world. We used PCO and filters air purifiers in households for two weeks, to understand the effects comparing with PCO.
| Study group | Role | What they receive |
|---|---|---|
| photocatalytic oxidation intervention | Sham comparator | Not described Receives: Other: Air purfiers with photocatalytic oxidation (PCO) |
| photocatalytic oxidation and filters intervention | Active comparator | Not described Receives: Other: Air purfiers with photocatalytic oxidation (PCO) + filters |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indoor air pollutants
The DustTrak DRX mass monitor (Model 8533, TSI, Shoreview, MN, USA) was used to measure PM1, PM2.5, PM4, PM10, and TSP continuously for 24 h, and UFPs were measured for 15 min at a time by using the P-Trak Ultrafine Particle Counter (Model 8525, TSI, Shoreview, MN, USA). The YesAir 15-channel indoor air quality monitor (Critical Environment Technologies Canada, Delta, British Columbia, Canada) was used to measure TVOC, NO2, SO2, CO, and CO2 continuously for 24 h.
Airborne bacteria and fungi were collected using MAS-100 air sampler, which is a single-stage microbiological sampler with tryptic soy agar (Difco Laboratories, Detroit, MI, USA) and malt extract agar (Difco Laboratories, Detroit, MI, USA).
Airborne endotoxin and mite samples were collected using 1-µm pore polytetrafluoroethylene (Teflon) membrane filters (Pall Corporation, Port Washington, NY, USA) placed in disposable plastic cassettes (37 mm; HIBLOW SPP-25 GA, Techno Takatsuki, Japan).
Measured: One day 0 (before intervention) and day 1 (after intervention)
Fractional exhaled nitric oxide (FeNO)
FeNO, considered an indicator of airway inflammation, was measured using the NIOX VERO device (Aerocrine AB, Solna, Sweden).
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
Blood pressure
We employed the HEM-8712 device (Omron Healthcare Co. Ltd., Japan) to measure blood pressure.
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
Heavy metals
We assessed 15 heavy metals in urine samples, including Cr, Mn, Fe, Co, Ni, As, Se, Rb, Sr, Cd, Cs, V, Cu, Zn, Mo, using an inductively coupled plasma mass spectrometer (ICP-MS, X-series II, Thermo Fisher Scientific, Germany).
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
Polycyclic aromatic hydrocarbons
We used SCIEX 4000QTRAP Triple Quadrupole Hybrid Linear Ion Trap Mass Spectrometer to assess urinary polycyclic aromatic hydrocarbons, including 1-hydroxypyrene, 2-Hydroxyfluorene, 1-Hydroxyphenanthrene, 4-Hydroxyphenanthrene.
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
microRNA
We evaluated miRNA, such as miR-146a-5p, miR-199a-5p, miR-21-5p, miR-222-3p, miR-155-5p, miR-29b-3p, miR-194-3p, using real time quantitative polymerase chain reaction (StepOnePlus™ Real-Time PCR System).
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
cell-free DNA
We evaluated cell-free DNA, using real time quantitative polymerase chain reaction (StepOnePlus™ Real-Time PCR System).
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
Cytokines
We evaluated cytokines, including IL-6, IL-8, IL-10, IL-13, IL-17A, IL-17F, IL-22, IL-25, IL-28A, IL-29, IL-31, IL-33, IL-34, and TGF-β1, using (Enzyme-linked immunosorbent assay, ELISA) assay (R \& D Systems, Minneapolis, MN).
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
slow vital capacity (SVC)
A multifunction spirometer (HI-801, Chest MI, Tokyo, Japan) was employed to assess the lung function.
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
forced expiratory volume in 1 s (FEV1)
A multifunction spirometer (HI-801, Chest MI, Tokyo, Japan) was employed.
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
forced vital capacity (FVC)
A multifunction spirometer (HI-801, Chest MI, Tokyo, Japan) was employed.
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
FEV1/FVC
A multifunction spirometer (HI-801, Chest MI, Tokyo, Japan) was employed to assess the lung function.
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
peak expiratory flow (PEF)
A multifunction spirometer (HI-801, Chest MI, Tokyo, Japan) was employed to assess the lung function.
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
maximal mid-expiratory flow (MMEF)
A multifunction spirometer (HI-801, Chest MI, Tokyo, Japan) was employed to assess the lung function.
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
forced expiratory flow (FEF) at 25% (FEF25)
A multifunction spirometer (HI-801, Chest MI, Tokyo, Japan) was employed to assess the lung function.
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
FEF50
A multifunction spirometer (HI-801, Chest MI, Tokyo, Japan) was employed to assess the lung function.
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
FEF75
A multifunction spirometer (HI-801, Chest MI, Tokyo, Japan) was employed to assess the lung function.
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
asthma control test (ACT)
The asthma control test (ACT) served as a measure of asthma control, with high scores indicating better control of the condition.
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
Respiratory symptoms score
The respiratory symptoms score evaluated in the questionnaire were stuffy nose, sneezing, runny nose, cough, shortness of breath, and chest tightness. The participants were asked to rate the severity of each respiratory symptom by using a 4-point scale, where 0, 1, 2, and 3 denoted no, mild, moderate, and severe symptoms, respectively.
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
COPD Assessment Test (CAT)
The COPD Assessment Test (CAT) includes eight items (cough, sputum, breathlessness, chest tightness, confidence, activity, sleep and energy levels), rated on a 5-point scale (1 to 5).
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
modified Medical Research Council Dyspnea Scale (mMRC)
The modified Medical Research Council Dyspnea Scale (mMRC) assessed dyspnea using a 5-grade scale (Grade 0 to Grade 4).
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
Breathlessness, Cough, and Sputum Scale (BCSS)
The Breathlessness, Cough, and Sputum Scale (BCSS) evaluated cough, sputum, and breathlessness using a 5-point scale (0 to 4).
Measured: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start29 Jun 2022
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- a double-blind, randomized, and crossover study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069907
- Sponsor's protocol ID
- KMUHIRB-SV(II)-20210120
- Status last verified
- Jun 2025
- First submitted
- 22 Jun 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not publicly available due to privacy and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Improvement of Indoor Air and Health Effects After Air Purifier Intervention Among Susceptible Population in Industrial Area
- ClinicalTrials.gov ID
- NCT07069907
- Acronym / sponsor ID
- KMUHIRB-SV(II)-20210120
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 17 Jul 2025 (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.
Invesitigators conducted a double-blind, randomized, and crossover study to investigate the effects of PCO and PCO + filters interventions on indoor air pollutants in households and health outcomes in susceptible group, such as asthma and COPD patients.
Detailed description
Invesitigators measured indoor air pollutants, including particulate matter, bioaerosols, gaseous pollutants, in households and health outcomes, including lung function, respiratory symptoms, fractional exhaled nitric oxide, blood pressure, biomarkers, urinary heavy metals, and polycyclic aromatic hydrocarbons, in susceptible group, such as asthma and COPD patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- a double-blind, randomized, and crossover study
| Arm | Type | Receives |
|---|---|---|
| photocatalytic oxidation intervention | Sham comparator | Other: Air purfiers with photocatalytic oxidation (PCO) |
| photocatalytic oxidation and filters intervention | Active comparator | Other: Air purfiers with photocatalytic oxidation (PCO) + filters |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- dianosed with asthma/COPD
Key exclusion criteria (1 listed)
- did not diagonse with asthma /COPD
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 |
|---|---|---|
| Air purfiers with photocatalytic oxidation (PCO)PCO was proved to decompose gaseous pollutants in chamber studies, while there is no study investigate the effects in real-world. We used PCO air purifiers in households for two weeks. | Other | photocatalytic oxidation intervention |
| Air purfiers with photocatalytic oxidation (PCO) + filtersPCO was proved to decompose gaseous pollutants in chamber studies, while there is no study investigate the effects in real-world. We used PCO and filters air purifiers in households for two weeks, to understand the effects comparing with PCO. | Other | photocatalytic oxidation and filters intervention |
Primary outcome
Indoor air pollutants
Time frame: One day 0 (before intervention) and day 1 (after intervention)
The DustTrak DRX mass monitor (Model 8533, TSI, Shoreview, MN, USA) was used to measure PM1, PM2.5, PM4, PM10, and TSP continuously for 24 h, and UFPs were measured for 15 min at a time by using the P-Trak Ultrafine Particle Counter (Model 8525, TSI, Shoreview, MN, USA). The YesAir 15-channel indoor air quality monitor (Critical Environment Technologies Canada, Delta, British Columbia, Canada) was used to measure TVOC, NO2, SO2, CO, and CO2 continuously for 24 h. Airborne bacteria and fungi were collected using MAS-100 air sampler, which is a single-stage microbiological sampler with tryptic soy agar (Difco Laboratories, Detroit, MI, USA) and malt extract agar (Difco Laboratories, Detroit, MI, USA). Airborne endotoxin and mite samples were collected using 1-µm pore polytetrafluoroethylene (Teflon) membrane filters (Pall Corporation, Port Washington, NY, USA) placed in disposable plastic cassettes (37 mm; HIBLOW SPP-25 GA, Techno Takatsuki, Japan).
Fractional exhaled nitric oxide (FeNO)
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
FeNO, considered an indicator of airway inflammation, was measured using the NIOX VERO device (Aerocrine AB, Solna, Sweden).
Blood pressure
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
We employed the HEM-8712 device (Omron Healthcare Co. Ltd., Japan) to measure blood pressure.
Heavy metals
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
We assessed 15 heavy metals in urine samples, including Cr, Mn, Fe, Co, Ni, As, Se, Rb, Sr, Cd, Cs, V, Cu, Zn, Mo, using an inductively coupled plasma mass spectrometer (ICP-MS, X-series II, Thermo Fisher Scientific, Germany).
Polycyclic aromatic hydrocarbons
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
We used SCIEX 4000QTRAP Triple Quadrupole Hybrid Linear Ion Trap Mass Spectrometer to assess urinary polycyclic aromatic hydrocarbons, including 1-hydroxypyrene, 2-Hydroxyfluorene, 1-Hydroxyphenanthrene, 4-Hydroxyphenanthrene.
microRNA
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
We evaluated miRNA, such as miR-146a-5p, miR-199a-5p, miR-21-5p, miR-222-3p, miR-155-5p, miR-29b-3p, miR-194-3p, using real time quantitative polymerase chain reaction (StepOnePlus™ Real-Time PCR System).
cell-free DNA
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
We evaluated cell-free DNA, using real time quantitative polymerase chain reaction (StepOnePlus™ Real-Time PCR System).
Cytokines
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
We evaluated cytokines, including IL-6, IL-8, IL-10, IL-13, IL-17A, IL-17F, IL-22, IL-25, IL-28A, IL-29, IL-31, IL-33, IL-34, and TGF-β1, using (Enzyme-linked immunosorbent assay, ELISA) assay (R \& D Systems, Minneapolis, MN).
slow vital capacity (SVC)
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
A multifunction spirometer (HI-801, Chest MI, Tokyo, Japan) was employed to assess the lung function.
forced expiratory volume in 1 s (FEV1)
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
A multifunction spirometer (HI-801, Chest MI, Tokyo, Japan) was employed.
forced vital capacity (FVC)
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
A multifunction spirometer (HI-801, Chest MI, Tokyo, Japan) was employed.
FEV1/FVC
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
A multifunction spirometer (HI-801, Chest MI, Tokyo, Japan) was employed to assess the lung function.
peak expiratory flow (PEF)
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
A multifunction spirometer (HI-801, Chest MI, Tokyo, Japan) was employed to assess the lung function.
maximal mid-expiratory flow (MMEF)
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
A multifunction spirometer (HI-801, Chest MI, Tokyo, Japan) was employed to assess the lung function.
forced expiratory flow (FEF) at 25% (FEF25)
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
A multifunction spirometer (HI-801, Chest MI, Tokyo, Japan) was employed to assess the lung function.
FEF50
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
A multifunction spirometer (HI-801, Chest MI, Tokyo, Japan) was employed to assess the lung function.
FEF75
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
A multifunction spirometer (HI-801, Chest MI, Tokyo, Japan) was employed to assess the lung function.
asthma control test (ACT)
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
The asthma control test (ACT) served as a measure of asthma control, with high scores indicating better control of the condition.
Respiratory symptoms score
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
The respiratory symptoms score evaluated in the questionnaire were stuffy nose, sneezing, runny nose, cough, shortness of breath, and chest tightness. The participants were asked to rate the severity of each respiratory symptom by using a 4-point scale, where 0, 1, 2, and 3 denoted no, mild, moderate, and severe symptoms, respectively.
COPD Assessment Test (CAT)
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
The COPD Assessment Test (CAT) includes eight items (cough, sputum, breathlessness, chest tightness, confidence, activity, sleep and energy levels), rated on a 5-point scale (1 to 5).
modified Medical Research Council Dyspnea Scale (mMRC)
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
The modified Medical Research Council Dyspnea Scale (mMRC) assessed dyspnea using a 5-grade scale (Grade 0 to Grade 4).
Breathlessness, Cough, and Sputum Scale (BCSS)
Time frame: On day 0 ( before intervention), day 7 and day 13 ( after intervention)
The Breathlessness, Cough, and Sputum Scale (BCSS) evaluated cough, sputum, and breathlessness using a 5-point scale (0 to 4).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: No. Individual participant data are not publicly available due to privacy and ethical restrictions.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air purfiers with photocatalytic oxidation (PCO) and Air purfiers with photocatalytic oxidation (PCO) + filters in people with Asthma (Diagnosis) and COPD (Chronic Obstructive Pulmonary Disease), run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Jul 2025. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indoor air pollutants (time frame: One day 0 (before intervention) and day 1 (after intervention)). The study lists 22 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 17 Jul 2025.