The Improvement of Indoor Air and Health Effects After Air Purifier Intervention Among Susceptible Population in Industrial Area

NCT07069907 | Completed

• 1 other identifier: KMUHIRB-SV(II)-20210120
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma (Diagnosis); COPD (Chronic Obstructive Pulmonary Disease)

Outcome Measures

Primary Outcomes (22)

• 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).

  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).

  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.

  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).

  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.

  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).

  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).

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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).

  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).

  On day 0 ( before intervention), day 7 and day 13 ( after intervention)

Study Arms (2)

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

Interventions

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.

photocatalytic oxidation intervention

Air purfiers with photocatalytic oxidation (PCO) + filters 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 and filters air purifiers in households for two weeks, to understand the effects comparing with PCO.

photocatalytic oxidation and filters intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• dianosed with asthma/COPD

You may not qualify if:

• did not diagonse with asthma /COPD

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University

Kaohsiung City, Kaohsiung, 807378, Taiwan

Location

MeSH Terms

Conditions

Asthma; Disease; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chronic Disease; Disease Attributes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a double-blind, randomized, and crossover study

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 17, 2025
• Study Start: June 29, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)