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临床试验/NCT07069907
NCT07069907已完成不适用

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 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年6月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
2
主要终点
FEV1/FVC

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •dianosed with asthma/COPD

排除标准

  • •did not diagonse with asthma /COPD

研究组 & 干预措施

photocatalytic oxidation intervention

Sham Comparator

干预措施: Air purfiers with photocatalytic oxidation (PCO) (Other)

photocatalytic oxidation and filters intervention

Active Comparator

干预措施: Air purfiers with photocatalytic oxidation (PCO) + filters (Other)

结局指标

主要结局

FEV1/FVC

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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