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Clinical Trials/NCT07069907
NCT07069907CompletedNot Applicable

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

Kaohsiung Medical University Chung-Ho Memorial Hospital2 sites in 1 country140 target enrollmentStarted: June 29, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
140
Locations
2
Primary Endpoint
FEV1/FVC

Study Overview

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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •dianosed with asthma/COPD

Exclusion Criteria

  • •did not diagonse with asthma /COPD

Arms & Interventions

photocatalytic oxidation intervention

Sham Comparator

Intervention: Air purfiers with photocatalytic oxidation (PCO) (Other)

photocatalytic oxidation and filters intervention

Active Comparator

Intervention: Air purfiers with photocatalytic oxidation (PCO) + filters (Other)

Outcomes

Primary Outcomes

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.

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.

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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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