Blood PressureNCT03500614
The Use of Air Cleaners to Mitigate Cardiopulmonary Health Impact of Indoor Exposure to Particles and Phthalates
A study testing Air cleaner use method 1 and Air cleaner use method 2 in people with Blood Pressure and Lung Function, run by Peking University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Lung Function, Inflammation
- What is being tested?
- Air cleaner use method 1 and Air cleaner use method 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2017to 1 Dec 2018
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Occupational & Environmental Health Sciences, School of Public Health, Peking University
Beijing, 100191
About this study
Official title: An Interventional Study on the Use of Air Cleaners to Mitigate Cardiopulmonary Health Impact of Indoor Exposure to Particles and Phthalates in Healthy Adults: a Randomized Double-blinded Crossover Trial.
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.
Read the detailed description
The randomized double-blind crossover trial includes two cohorts with different intervention and health examination settings and will be conducted in Beijing, China between November 2017-May 2018.
The first cohort plans to include 70 healthy college students who live in school dormitories, which were randomized into two dormitory groups to receive either true or sham air cleaner treatment for 1 week and then alternate the treatment after a wash out interval of at least 2 weeks (But in the enrollment, only 57 students were recruited actually). All participants and research staff are blinded to the group assignment. All participants are encouraged to stay in the dormitory with windows/doors tightly closed throughout the 1-week treatment period as far as possible, whereas necessary outdoor activities such as attending classes and dining in school canteens are allowed. All interventions will start at noon on Tuesday or Thursday and continue to the next morning of Tuesday or Thursday to avoid issues related to diurnal variation. Real-time PM2.5 concentrations will be measured using portable monitors and airborne PM2.5 mass samples will be collected in air filters throughout the treatment period. Air and fine particle phase phthalates samples will be collected using glass sampling tube filled with XAD2 macroporous resin and PM2.5 air filters respectively during the last day (24 hours) of the treatment period. Health variables, including blood pressure, lung function, fractional exhaled nitric oxide (FeNO), will be evaluated and biological samples including morning urine and fasting blood will be collected immediately after the completion of each treatment period. Efficacy of air cleaner treatment to reduce indoor exposure to particles and phthalates and related improvements in cardiopulmonary health variables will be evaluated using professional statistical methods.
The second cohort plans to include 30 healthy college students who will undergo extended treatment period covering the start, peak and end phases of smog episodes occurring in Beijing (To avoid dropout, 32 students were initially recruited). All interventions will start from the beginning to the end of typical smog episodes. PM2.5 exposure monitoring as detailed above will be performed 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. Efficacy of air cleaner treatment to reduce indoor exposure to PM2.5 and related improvements in cardiopulmonary health variables throughout the smog episodes will be evaluated using professional statistical methods.
- Conditions
- Blood Pressure, Lung Function, Inflammation, Oxidative Stress
- Being tested
- Air cleaner use method 1, Air cleaner use method 2
- Keywords
- particulate matter, phthalates, cytokines, chemokines, epigenetics, DNA methylation, peripheral blood mononuclear cells, immune function
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air cleaner use method 1Behavioural
All interventions in the first cohort will start at noon on Tuesday or Thursday and continue to the next morning of Tuesday or Thursday.
Air cleaner use method 2Behavioural
All interventions in the second cohort will start from the beginning to the end of smog episodes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Air cleaner use method 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: before, during and after the smog episodes (up to 10 days)
Secondary outcomes (3)
DNA methylation (cohort 1)
Genomic DNA methylation changes associated with indoor exposures will be screened using methylation chip in a group of selected participants and confirmed in both cohorts using bisulfite-polymerase chain reaction-pyrosequencing.
Measured: through the study completion, an average of 1-week
Concentrations of urinary phthalate metabolites (cohort 1）
Fifteen main phthalate metabolites in morning urine samples including dimethyl phthalate (DMP), diethylphthalate (DEP), diisobuylphthalate (DIBP), dibutyl phthalate (DBP), bis(2-Methoxyethyl)phthalate (DMEP), bis(4-Methyl-2-pentyl)phthalate (DMPP), bis(2-Ethoxyethyl)phthalate (DEEP), dipentyl phthalate (DPP), dihexyl phthalate (DHP), benzyl butyl phthalate (BBP), bis(2-n-butoxyethyl)phthalate (DBEP), dicyclohexyl phthalate (DCHP), bis(2-Ethylhexyl)phthalate (DEHP), di-n-octyl phthalate (DnOP), dinonyl phthalate (DNP) will be quantified using gas chromatography-mass spectrometry (GC-MS).
Measured: through the study completion, an average of 1-week
Change in DNA methylation from baseline to during and after the intervention (cohort 2)
Genomic DNA methylation changes associated with indoor exposures will be screened using methylation chip in a group of selected participants and confirmed in both cohorts using bisulfite-polymerase chain reaction-pyrosequencing.
Measured: before, during and after the smog episodes (up to 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start14 Nov 2017
- Primary completion23 Apr 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Huang, Peking University
- Investigators
- Jing Huang, PhD, Principal investigator, Peking UniversityShaowei Wu, PhD, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03500614
- Sponsor's protocol ID
- 2017095
- Other IDs
- 2017YFC0211601, 2016YFC0207103
- Status last verified
- Oct 2021
- First submitted
- 13 Mar 2018
- Last updated
- 15 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Study on the Use of Air Cleaners to Mitigate Cardiopulmonary Health Impact of Indoor Exposure to Particles and Phthalates in Healthy Adults: a Randomized Double-blinded Crossover Trial.
- ClinicalTrials.gov ID
- NCT03500614
- Acronym / sponsor ID
- 2017095
- Conditions
- Blood Pressure, Lung Function, Inflammation, Oxidative Stress
- Keywords
- particulate matter, phthalates, cytokines, chemokines, epigenetics, DNA methylation, peripheral blood mononuclear cells, immune function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 23 Apr 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 18 Apr 2018 (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.
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.
Detailed description
The randomized double-blind crossover trial includes two cohorts with different intervention and health examination settings and will be conducted in Beijing, China between November 2017-May 2018.
The first cohort plans to include 70 healthy college students who live in school dormitories, which were randomized into two dormitory groups to receive either true or sham air cleaner treatment for 1 week and then alternate the treatment after a wash out interval of at least 2 weeks (But in the enrollment, only 57 students were recruited actually). All participants and research staff are blinded to the group assignment. All participants are encouraged to stay in the dormitory with windows/doors tightly closed throughout the 1-week treatment period as far as possible, whereas necessary outdoor activities such as attending classes and dining in school canteens are allowed. All interventions will start at noon on Tuesday or Thursday and continue to the next morning of Tuesday or Thursday to avoid issues related to diurnal variation. Real-time PM2.5 concentrations will be measured using portable monitors and airborne PM2.5 mass samples will be collected in air filters throughout the treatment period. Air and fine particle phase phthalates samples will be collected using glass sampling tube filled with XAD2 macroporous resin and PM2.5 air filters respectively during the last day (24 hours) of the treatment period. Health variables, including blood pressure, lung function, fractional exhaled nitric oxide (FeNO), will be evaluated and biological samples including morning urine and fasting blood will be collected immediately after the completion of each treatment period. Efficacy of air cleaner treatment to reduce indoor exposure to particles and phthalates and related improvements in cardiopulmonary health variables will be evaluated using professional statistical methods.
The second cohort plans to include 30 healthy college students who will undergo extended treatment period covering the start, peak and end phases of smog episodes occurring in Beijing (To avoid dropout, 32 students were initially recruited). All interventions will start from the beginning to the end of typical smog episodes. PM2.5 exposure monitoring as detailed above will be performed 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. Efficacy of air cleaner treatment to reduce indoor exposure to PM2.5 and related improvements in cardiopulmonary health variables throughout the smog episodes will be evaluated using professional statistical methods.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Behavioral: Air cleaner use method 1Participants (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. |
| Cohort 2 | Experimental | Behavioral: Air cleaner use method 2Participants (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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Current or ever smokers;
- A history of chronic respiratory diseases;
- A history of chronic cardiovascular diseases;
- Acute infections;
- Medication use in recent one month;
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 cleaner use method 1All interventions in the first cohort will start at noon on Tuesday or Thursday and continue to the next morning of Tuesday or Thursday. | Behavioural | Cohort 1 |
| Air cleaner use method 2All interventions in the second cohort will start from the beginning to the end of smog episodes. | Behavioural | Cohort 2 |
Primary outcome
Blood pressure (BP) (cohort 1)
Time frame: through the study completion, an average of 1-week
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.
Lung function (cohort 1)
Time frame: through the study completion, an average of 1-week
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.
Fractional exhaled nitric oxide (FeNO) (cohort 1)
Time frame: through the study completion, an average of 1-week
FeNO levels will be measured using a portable NIOX VERO machine (Aerocrine AB, Solna, Sweden).
Urinary oxidative biomarkers (cohort 1)
Time frame: through the study completion, an average of 1-week
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).
Circulating cytokine and chemokine biomarkers (cohort 1)
Time frame: through the study completion, an average of 1-week
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.
Inflammatory and immune markers for peripheral blood mononuclear cell (PBMC) (cohort 1)
Time frame: through the study completion, an average of 1-week
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.
Change in blood pressure from baseline to during and after the intervention (cohort 2)
Time frame: before, during and after the smog episodes (up to 10 days)
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.
Change in lung function from baseline to during and after the intervention (cohort 2)
Time frame: before, during and after the smog episodes (up to 10 days)
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.
Change in fractional exhaled nitric oxide (FeNO) from baseline to during and after the intervention (cohort 2)
Time frame: before, during and after the smog episodes (up to 10 days)
FeNO levels will be measured using a portable NIOX VERO machine (Aerocrine AB, Solna, Sweden).
Change in urinary oxidative biomarkers from baseline to during and after the intervention (cohort 2)
Time frame: before, during and after the smog episodes (up to 10 days)
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).
Change in circulating cytokine and chemokine biomarkers from baseline to during and after the intervention (cohort 2)
Time frame: before, during and after the smog episodes (up to 10 days)
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.
3 secondary outcomes
DNA methylation (cohort 1)
Time frame: through the study completion, an average of 1-week
Concentrations of urinary phthalate metabolites (cohort 1）
Time frame: through the study completion, an average of 1-week
Change in DNA methylation from baseline to during and after the intervention (cohort 2)
Time frame: before, during and after the smog episodes (up to 10 days)
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 15 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Jing Huang, PhD principal investigator
Peking University
Shaowei Wu, PhD principal investigator
Peking University
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 cleaner use method 1 and Air cleaner use method 2 in people with Blood Pressure and Lung Function, run by Peking University at 1 site in China.
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 3 inclusion and 6 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 15 Oct 2021. 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 China. 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. 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?
Blood pressure (BP) (cohort 1) (time frame: through the study completion, an average of 1-week). The study lists 11 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 15 Oct 2021.