The Use of Air Cleaners to Mitigate Cardiopulmonary Health Impact of Indoor Exposure to Particles and Phthalates

NCT03500614 | Completed

• 3 other identifiers: 20170952017YFC02116012016YFC0207103
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate whether a short-term intervention strategy using air cleaner reduces indoor exposure to airborne particles (particulate matter with an aerodynamic diameter ≤2.5μm, PM2.5) and phthalates and improves cardiopulmonary health among Chinese healthy adults based on a randomized double-blinded crossover trial.

Conditions

Blood Pressure; Lung Function; Inflammation; Oxidative Stress

Keywords

particulate matter; phthalates; cytokines; chemokines; epigenetics; DNA methylation; peripheral blood mononuclear cells; immune function

Outcome Measures

Primary Outcomes (11)

• Blood pressure (BP) (cohort 1)

  The upper arm BP including both systolic pressure and diastolic pressure will be measured using an Omron J12 electronic sphygmomanometer for three times and the second and third readings will be used.

  through the study completion, an average of 1-week

• Lung function (cohort 1)

  Lung function measures including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and peak expiratory flow (PEF) will be determined using a Pony FX spirometer.

  through the study completion, an average of 1-week

• Fractional exhaled nitric oxide (FeNO) (cohort 1)

  FeNO levels will be measured using a portable NIOX VERO machine (Aerocrine AB, Solna, Sweden).

  through the study completion, an average of 1-week

• Urinary oxidative biomarkers (cohort 1)

  Morning urine samples will be collected and measured for malondialdehyde (MDA) and 8-iso-prostaglandinF2α (8-iso-PGF2α) using high performance liquid chromatography-mass spectrometry (HPLC-MS) and 8-hydroxydeoxyguanosine (8-OHdG) using enzyme linked immunosorbent assay (ELISA).

  through the study completion, an average of 1-week

• Circulating cytokine and chemokine biomarkers (cohort 1)

  Peripheral blood samples will be collected and measured for soluble CD40L(sCD40L), epidermal growth factor(EGF), Eotaxin-1, fibroblast growth factor 2(FGF2), fms-related tyrosine kinase 3 ligand(FLT3LG), Fractalkine, granulocyte-colony stimulating factor(G-CSF), granulocyte-macrophage colony-stimulating factor(GM-CSF), growth-related oncogene α(GROα), interferon-α2(IFN-α2), IFN-γ, interleukin-1α(IL-1α), IL-1β, IL-1R1, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p40, IL-12, IL-13, IL-15, IL-17, interferon-inducible protein-10(IP-10), monocyte chemoattractant protein-1(MCP-1), MCP-3, macrophage-derived chemokine(MDC), macrophage inflammatory protein-1α(MIP-1α), MIP-1β, platelet-derived growth factor-AA(PDGF-AA), PDGF-AB/BB, regulated upon activation normal T-cell expressed and secreted(RANTES), transforming growth factor-α(TGF-α), tumor necrosis factor-α(TNF-α), TNF-β and vascular endothelial growth factor(VEGF) using a liquid chip in Luminex platform.

  through the study completion, an average of 1-week

• Inflammatory and immune markers for peripheral blood mononuclear cell (PBMC) (cohort 1)

  The following inflammatory and immune markers of PBMC will be measured using labeled antibodies in multiplexed mass cytometry: p53, phospho-p53 (p-p53), p-mitogen-activated protein kinase 1/2 (pErk1/2), cell devision cycle protein 2 (cdc2), p-cdc2, signal transducer and activator of transcription 3 (STAT3), p-STAT3, serine/threonine kinase 1, ataxia telangiectasia mutated (ATM), p-ATM, p62, mammalian target of rapamycin (mTOR), p-mTOR, mitogen-activated protein kinases1+2, nuclear factor-kappa B p65 (NF-κB p65), p-NF-κB p65, c-Jun N-terminal kinase (JNK), p-JNK, glycoprotein 130 (gp130), p-gp130, Cyclin B1, p-Cyclin B1, phosphorylation protein kinase B, autophagy related gene 5, cluster differentiation antigen 4 (CD4), CD8, CD11c, CD14, CD20, CD56, toll-like receptor 4, myeloid differentiation primary response 88, TNF receptor associated factor 6, and interleukin-1 receptor-associated kinase 4.

  through the study completion, an average of 1-week

• Change in blood pressure from baseline to during and after the intervention (cohort 2)

  The upper arm BP including both systolic pressure and diastolic pressure will be measured using an Omron J12 electronic sphygmomanometer for three times and the second and third readings will be used.

  before, during and after the smog episodes (up to 10 days)

• Change in lung function from baseline to during and after the intervention (cohort 2)

  Lung function measures including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and peak expiratory flow (PEF) will be determined using a Pony FX spirometer.

  before, during and after the smog episodes (up to 10 days)

• Change in fractional exhaled nitric oxide (FeNO) from baseline to during and after the intervention (cohort 2)

  FeNO levels will be measured using a portable NIOX VERO machine (Aerocrine AB, Solna, Sweden).

  before, during and after the smog episodes (up to 10 days)

• Change in urinary oxidative biomarkers from baseline to during and after the intervention (cohort 2)

  Morning urine samples will be collected and measured for malondialdehyde (MDA) and 8-iso-prostaglandinF2α (8-iso-PGF2α) using high performance liquid chromatography-mass spectrometry (HPLC-MS) and 8-hydroxydeoxyguanosine (8-OHdG) using enzyme linked immunosorbent assay (ELISA).

  before, during and after the smog episodes (up to 10 days)

• Change in circulating cytokine and chemokine biomarkers from baseline to during and after the intervention (cohort 2)

  Peripheral blood samples will be collected and measured for soluble CD40L(sCD40L), epidermal growth factor(EGF), Eotaxin-1, fibroblast growth factor 2(FGF2), fms-related tyrosine kinase 3 ligand(FLT3LG), Fractalkine, granulocyte-colony stimulating factor(G-CSF), granulocyte-macrophage colony-stimulating factor(GM-CSF), growth-related oncogene α(GROα), interferon-α2(IFN-α2), IFN-γ, interleukin-1α(IL-1α), IL-1β, IL-1R1, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p40, IL-12, IL-13, IL-15, IL-17, interferon-inducible protein-10(IP-10), monocyte chemoattractant protein-1(MCP-1), MCP-3, macrophage-derived chemokine(MDC), macrophage inflammatory protein-1α(MIP-1α), MIP-1β, platelet-derived growth factor-AA(PDGF-AA), PDGF-AB/BB, regulated upon activation normal T-cell expressed and secreted(RANTES), transforming growth factor-α(TGF-α), tumor necrosis factor-α(TNF-α), TNF-β and vascular endothelial growth factor(VEGF) using a liquid chip in Luminex platform.

  before, during and after the smog episodes (up to 10 days)

Secondary Outcomes (3)

• DNA methylation (cohort 1)

  through the study completion, an average of 1-week

• Concentrations of urinary phthalate metabolites (cohort 1）

  through the study completion, an average of 1-week

• Change in DNA methylation from baseline to during and after the intervention (cohort 2)

  before, during and after the smog episodes (up to 10 days)

Study Arms (2)

Cohort 1

EXPERIMENTAL

Participants (n=57) will receive either true or sham air cleaner treatment for 1 week and then alternate the treatment after a wash out interval (Air cleaner use method 1). Exposure monitoring for PM2.5 will continue throughout the treatment period and air and fine particle phase phthalates samples will be collected during the last day (24 hours) of the treatment period; and health variables will be measured and biological samples will be collected immediately after the completion of each intervention period.

Behavioral: Air cleaner use method 1

Cohort 2

EXPERIMENTAL

Participants (n=32) will undergo extended treatment period covering the start, peak and end phases of smog episodes in Beijing, with either true or sham air cleaner treatment and then alternate the treatment after a wash out interval (Air cleaner use method 2). Exposure monitoring for PM2.5 will continue throughout the treatment period and repeated health examinations will be conducted at time points corresponding to the start, peak and end phases of the smog episodes.

Behavioral: Air cleaner use method 2

Interventions

Air cleaner use method 1 BEHAVIORAL

All interventions in the first cohort will start at noon on Tuesday or Thursday and continue to the next morning of Tuesday or Thursday.

Cohort 1

Air cleaner use method 2 BEHAVIORAL

All interventions in the second cohort will start from the beginning to the end of smog episodes.

Cohort 2

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy college students aged between 18 and 30 years old;
• Will stay within the central urban area of Beijing over the entire study including the wash-out period;
• BMI \<30 kg/m3.

You may not qualify if:

• Current or ever smokers;
• A history of chronic respiratory diseases;
• A history of chronic cardiovascular diseases;
• Acute infections;
• Medication use in recent one month;
• Leave Beijing during the intervention.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Department of Occupational & Environmental Health Sciences, School of Public Health, Peking University

Beijing, 100191, China

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jing Huang, PhD

  Peking University

  PRINCIPAL INVESTIGATOR

• Shaowei Wu, PhD

  Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: April 18, 2018
• Study Start: November 14, 2017
• Primary Completion: April 23, 2018
• Study Completion: December 1, 2018
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)