COPDPhase 4APICNCT06552364
Air Pollution and Inhaled Corticosteroids in COPD
A Phase 4 study testing LABA+LAMA, LABA+LAMA+ICS and Filtered Air in people with COPD, run by University of British Columbia.
Trial summary
Studies have shown that people with chronic obstructive pulmonary disease (COPD) have worse symptoms after breathing polluted air. People with COPD also often need to go to the hospital if they get a virus or other bug. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD
- What is being tested?
- LABA+LAMA, LABA+LAMA+ICS and Filtered Air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2025to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 40 to 80
- Mild-to-moderate COPD diagnosis (Global Initiative for Chronic Obstructive Lung Disease stage 1-2) as confirmed by medical history, questionnaires, and spirometry (a test that measures the amount of air one can breathe in and out of the lungs) results
- Spirometry results will be assessed by the study physician to determine eligibility
Who cannot join
- Currently smoking or have been smoking within six months of your screening visit for this study
- Have had an acute exacerbation of COPD (AECOPD) diagnosis within 365 days of the screening visit
- Have a history of asthma or asthma-COPD overlap syndrome
- Existing medical condition or other health concerns as assessed by the study physician
- Pregnant, plan to be pregnant, or breastfeeding during your enrolment in the study. Participants of childbearing potential will be required to have a negative pregnancy test prior to study inclusion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Studies have shown that people with chronic obstructive pulmonary disease (COPD) have worse symptoms after breathing polluted air. People with COPD also often need to go to the hospital if they get a virus or other bug. One of the main drugs taken for COPD treatment (inhaled corticosteroid) may change COPD patients' lungs in ways that make it harder to deal with bugs, especially if they breathe in polluted air. If so, this could cause more frequent hospital visits. On the other hand, the same drug (inhaled corticosteroid) helps some people control symptoms, and may help them avoid hospital visits. The APEL investigators are conducting this study (APIC) to understand if this drug (inhaled corticosteroid), in combination with polluted air, will change the lungs of those with COPD in ways that make it more likely to catch bugs or have other problems.
Read the detailed description
APIC will involve 48 volunteer participants (24 of each biological sex assigned at birth) with mild-to-moderate COPD where the researchers will look at what (if any) are the differences between breathing in fresh air (filtered air - FA) or polluted air (diesel exhaust - DE) while taking the drug (Inhaled corticosteroid - ICS) or not (no ICS), both in combination with two standard COPD medicines that make it easier to breath (a long-acting beta-agonist and a long-acting muscarinic antagonist). The participant will take an inhaled medication daily throughout the study. This study will use a controlled amount of diesel exhaust to model traffic-related air pollution (TRAP), a commonly encountered form of polluted air.
Each participant will act as their own control, as they will experience all four combinations: 1) FA-ICS, 2) FA-no ICS, 3) DE-ICS, and 4) DE-no ICS. These combinations will be randomized in what researchers call a double-blinded crossover study, so that every participant will get these combinations in a different order. However, only the engineer on the team will be allowed to know which participant gets what. Blinding will prevent everyone else, including the participant, from being biased against the conditions and affecting outcomes based on this perception.
The study will span over five months (approximately 121 days of active commitment), which includes ten in-person visits to a research office at the Vancouver General Hospital, for a total of approximately 40 hours. While the participant is on-site, the investigators will supervise a series of questionnaires, sample collection (blood, urine, bronchoscopy lung samples), and lung function tests. The investigators will evaluate multiple endpoints as detailed in the Outcome Measures section. For each applicable endpoint, the investigators will evaluate stratified analyses and effect modification by biological sex, participant age, gene score, and microbiomes.
The investigators do not expect that the participant's responses to either the corticosteroid or diesel exhaust will be noticeable to them. Any responses that may occur will probably only be detectable through careful examination of their cells and tissues (e.g., blood, urine, bronchial samples). However, understanding the subtle changes that may occur could help reduce or prevent health problems associated with TRAP exposure in the future.
- Conditions
- COPD
- Being tested
- LABA+LAMA, LABA+LAMA+ICS, Filtered Air, Diesel Exhaust
- Keywords
- Air Pollution, Inhaled Corticosteroid, LABA/LAMA, Triple Therapy (LABA/LAMA/ICS)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LABA+LAMADrug
Also called Anoro Ellipta
1 dose per day (AM)
LABA+LAMA+ICSDrug
Also called Trelegy Ellipta
1 dose per day (AM)
Filtered AirOther
Exposure to HEPA filtered air, as a control
Diesel ExhaustOther
Also called Traffic Related Air Pollution
Diesel exhaust standardized to 300µg/m³ of particulate matter with a diameter of 2.5 micrometers or less (PM2.5).
| Study group | Role | What they receive |
|---|---|---|
| Filtered Air with LABA/LAMA | Placebo comparator | Participants will inhale a ultra Long-Acting Beta-Agonist (LABA; vilanterol (25mcg)) + Long-acting Muscarinic Antagonist (LAMA; umeclidinium (62.5mcg)) combination medication once daily for 28+ days before sitting in a booth and being exposed to high-efficiency particulate air (HEPA) filtered air for 2 hours. Receives: Drug: LABA+LAMA; Other: Filtered Air |
| Filtered Air with LABA/LAMA + ICS | Active comparator | Participants will inhale a LABA (vilanterol (25mcg)) + LAMA (umeclidinium (62.5mcg))+ Inhaled Corticosteroid (ICS; fluticasone furoate (100mcg)) medication once daily for 28+ days before sitting in a booth and being exposed to HEPA-filtered air for 2 hours. Receives: Drug: LABA+LAMA+ICS; Other: Filtered Air |
| Diesel Exhaust with LABA/LAMA | Active comparator | Participants will inhale a LABA (vilanterol (25mcg)) + LAMA (umeclidinium (62.5mcg)) medication once daily for 28+ days before sitting in a booth and being exposed to diesel exhaust (standardized to 300µg/m³ of particulate matter with a diameter of 2.5 micrometers or less (PM2.5)) for 2 hours. Receives: Drug: LABA+LAMA; Other: Diesel Exhaust |
| Diesel Exhaust with LABA/LAMA + ICS | Experimental | Participants will inhale a LABA (vilanterol (25mcg)) + LAMA (umeclidinium (62.5mcg))+ Inhaled Corticosteroid (ICS; fluticasone furoate (100mcg)) medication once daily for 28+ days before sitting in a booth and being exposed to diesel exhaust (300ug/m3 of PM2.5) for 2 hours. Receives: Drug: LABA+LAMA+ICS; Other: Diesel Exhaust |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure effects on inflammatory cells.
Differentially count lung cells.
Measured: Comparison of the different arms over the span of 5 months.
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure effects on exhaled nitric oxide.
Measurement of fractional exhaled nitric oxide (FeNO).
Measured: Comparison of the different arms over the span of 5 months.
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure effects on anti-microbial host defense proteins.
Anti-microbial host defense (AMP) matrix, determined from, for example, human neutrophil peptide 1 (HNP1; DEFA1), calprotectin (S100A8/S100A9), cathelicidin antimicrobial peptide/LL-37, Lipocalin-2 (LCN2), and S100 calcium-binding protein A7 (S100A7) in the lungs. And dermcidin (DCD), calprotectin (S100A8/S100A9), cathelicidin antimicrobial peptide/LL-37, and amphiregulin (AREG) in peripheral blood.
Measured: Comparison of the different arms over the span of 5 months.
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure effects on oxidative stress in the lungs.
Determine oxidative stress (e.g. H2DCFDA) in the lungs.
Measured: Comparison of the different arms over the span of 5 months.
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure effects on neutrophil extracellular TRAPs (NETs).
Analysis of counts of neutrophil extracellular TRAPs (NETs).
Measured: Comparison of the different arms over the span of 5 months.
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure effects on lung inflammatory markers.
An inflammation matrix will be generated, including data from RNA and proteins (e.g. serum amyloid A (SAA), c-reactive protein (CRP), chemokine ligand 18 (CCL18) and fibrinogen), in the lungs.
Measured: Comparison of the different arms over the span of 5 months.
Secondary outcomes (10)
Inhaled corticosteroids (ICS) and/or diesel exhaust exposure induced modulation of circulating markers of inflammation.
An inflammation matrix will be generated, including data from RNA and proteins (e.g., CRP, CCL18, fibrinogen, CX3CL1, CCL23, CXCL8, SAA, MMP9, MMP12, APOB, APOM) in peripheral blood.
Measured: Comparison of the different arms over the span of 5 months.
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure induced modulation of circulating cells and inflammatory cellular markers.
Measurement of cellular inflammation scores from complete cell counts, and cellular markers (e.g. CD80, CD86, HLA-DR, CD283, CD288, CD119, TLR7, CD16, CD64, CD11b, CD206, CXCR2) in peripheral blood.
Measured: Comparison of the different arms over the span of 5 months.
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure induced modulation of lung resistance as assessed by oscillometry.
Lung resistance and reactivity from respiratory oscillometry Rrs5, Rrs20, Rrs5-20, Xrs5, AX and Fres.
Measured: Comparison of the different arms over the span of 5 months.
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure effects on lung function.
Lung function as evaluated by spirometry (e.g. FEV1).
Measured: Comparison of the different arms over the span of 5 months.
Effects of inhaled corticosteroids (ICS) and/or diesel exhaust on neutrophil function.
Neutrophil respiratory burst (Fc-OxyBURST Green) measurement.
Measured: Comparison of the different arms over the span of 5 months.
Effects of inhaled corticosteroids (ICS) and/or diesel exhaust on phagocytosis.
Measurement of phagocytosis (fluorescein isothiocyanate-labelled opsonized S. cerevisiae zymosan-A bioparticles uptake).
Measured: Comparison of the different arms over the span of 5 months.
Effects of inhaled corticosteroids (ICS) and/or diesel exhaust on the EXACT (and E-RS:COPD) questionnaire.
The EXACT (and its derivative instrument E-RS (Evaluating Respiratory Symptoms):COPD) questionnaire (see https://www.evidera.com/what-we-do/patient-centered-research/coa-instrument-management-services/exact-program/exact-content/) will be completed.
Measured: Comparison of the different arms over the span of 5 months.
Effects of inhaled corticosteroids (ICS) and/or diesel exhaust on the mMRC dyspnea scale questionnaire.
The modified Medical Research Council (mMRC) Dyspnea Scale (see https://www.pcrs-uk.org/mrc-dyspnoea-scale) will be completed.
Measured: Comparison of the different arms over the span of 5 months.
Effects of inhaled corticosteroids (ICS) and/or diesel exhaust on the Symptoms and Perception questionnaire.
The Symptoms and Perception questionnaire (see https://particleandfibretoxicology.biomedcentral.com/articles/10.1186/s12989-022-00506-6#Sec15) will be completed.
Measured: Comparison of the different arms over the span of 5 months.
Effects of inhaled corticosteroids (ICS) and/or diesel exhaust on the Perceived Stress Scale questionnaire.
The Perceived Stress Scale questionnaire (see https://www.das.nh.gov/wellness/docs/percieved%20stress%20scale.pdf) will be completed.
Measured: Comparison of the different arms over the span of 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start1 Apr 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will become their own control as they experience all four combinations of exposures at four different time intervals, each separated by at least a month for washout: 1) Filtered Air-Inhaled Corticosteroid (FA-ICS), 2) Filtered Air- No Inhaled Corticosteroid (FA-no ICS), 3) Diesel Exhaust-Inhaled Corticosteroid (DE-ICS), and 4) Diesel Exhaust- No Inhaled Corticosteroid (DE-no ICS).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, University of Ottawa, University of Manitoba, University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Christopher Carlsten, University of British Columbia
- Investigators
- Christopher Carlsten, MD, MPH, Principal investigator, University of British ColumbiaNeeloffer Mookherjee, PhD, Principal investigator, University of ManitobaShawn Aaron, MD, FRCPC, Principal investigator, University of Ottawa/Université d'OttawaJanice Leung, MD, FRCPC, Principal investigator, University of British ColumbiaChristopher F Rider, PhD, Principal investigator, University of British ColumbiaNeil Alexis, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06552364
- Sponsor's protocol ID
- H22-03008
- Acronym
- APIC
- Status last verified
- Mar 2025
- First submitted
- 28 Mar 2024
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Pollution and Inhaled Corticosteroids in COPD
- ClinicalTrials.gov ID
- NCT06552364
- Acronym / sponsor ID
- APIC / H22-03008
- Conditions
- COPD
- Keywords
- Air Pollution, Inhaled Corticosteroid, LABA/LAMA, Triple Therapy (LABA/LAMA/ICS)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- University of Calgary, University of Ottawa, University of Manitoba, University of North Carolina, Chapel Hill
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 14 Aug 2024 (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.
Studies have shown that people with chronic obstructive pulmonary disease (COPD) have worse symptoms after breathing polluted air. People with COPD also often need to go to the hospital if they get a virus or other bug. One of the main drugs taken for COPD treatment (inhaled corticosteroid) may change COPD patients' lungs in ways that make it harder to deal with bugs, especially if they breathe in polluted air. If so, this could cause more frequent hospital visits. On the other hand, the same drug (inhaled corticosteroid) helps some people control symptoms, and may help them avoid hospital visits. The APEL investigators are conducting this study (APIC) to understand if this drug (inhaled corticosteroid), in combination with polluted air, will change the lungs of those with COPD in ways that make it more likely to catch bugs or have other problems.
Detailed description
APIC will involve 48 volunteer participants (24 of each biological sex assigned at birth) with mild-to-moderate COPD where the researchers will look at what (if any) are the differences between breathing in fresh air (filtered air - FA) or polluted air (diesel exhaust - DE) while taking the drug (Inhaled corticosteroid - ICS) or not (no ICS), both in combination with two standard COPD medicines that make it easier to breath (a long-acting beta-agonist and a long-acting muscarinic antagonist). The participant will take an inhaled medication daily throughout the study. This study will use a controlled amount of diesel exhaust to model traffic-related air pollution (TRAP), a commonly encountered form of polluted air.
Each participant will act as their own control, as they will experience all four combinations: 1) FA-ICS, 2) FA-no ICS, 3) DE-ICS, and 4) DE-no ICS. These combinations will be randomized in what researchers call a double-blinded crossover study, so that every participant will get these combinations in a different order. However, only the engineer on the team will be allowed to know which participant gets what. Blinding will prevent everyone else, including the participant, from being biased against the conditions and affecting outcomes based on this perception.
The study will span over five months (approximately 121 days of active commitment), which includes ten in-person visits to a research office at the Vancouver General Hospital, for a total of approximately 40 hours. While the participant is on-site, the investigators will supervise a series of questionnaires, sample collection (blood, urine, bronchoscopy lung samples), and lung function tests. The investigators will evaluate multiple endpoints as detailed in the Outcome Measures section. For each applicable endpoint, the investigators will evaluate stratified analyses and effect modification by biological sex, participant age, gene score, and microbiomes.
The investigators do not expect that the participant's responses to either the corticosteroid or diesel exhaust will be noticeable to them. Any responses that may occur will probably only be detectable through careful examination of their cells and tissues (e.g., blood, urine, bronchial samples). However, understanding the subtle changes that may occur could help reduce or prevent health problems associated with TRAP exposure in the future.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will become their own control as they experience all four combinations of exposures at four different time intervals, each separated by at least a month for washout: 1) Filtered Air-Inhaled Corticosteroid (FA-ICS), 2) Filtered Air- No Inhaled Corticosteroid (FA-no ICS), 3) Diesel Exhaust-Inhaled Corticosteroid (DE-ICS), and 4) Diesel Exhaust- No Inhaled Corticosteroid (DE-no ICS).
| Arm | Type | Receives |
|---|---|---|
| Filtered Air with LABA/LAMA | Placebo comparator | Drug: LABA+LAMA, Other: Filtered AirParticipants will inhale a ultra Long-Acting Beta-Agonist (LABA; vilanterol (25mcg)) + Long-acting Muscarinic Antagonist (LAMA; umeclidinium (62.5mcg)) combination medication once daily for 28+ days before sitting in a booth and being exposed to high-efficiency particulate air (HEPA) filtered air for 2 hours. |
| Filtered Air with LABA/LAMA + ICS | Active comparator | Drug: LABA+LAMA+ICS, Other: Filtered AirParticipants will inhale a LABA (vilanterol (25mcg)) + LAMA (umeclidinium (62.5mcg))+ Inhaled Corticosteroid (ICS; fluticasone furoate (100mcg)) medication once daily for 28+ days before sitting in a booth and being exposed to HEPA-filtered air for 2 hours. |
| Diesel Exhaust with LABA/LAMA | Active comparator | Drug: LABA+LAMA, Other: Diesel ExhaustParticipants will inhale a LABA (vilanterol (25mcg)) + LAMA (umeclidinium (62.5mcg)) medication once daily for 28+ days before sitting in a booth and being exposed to diesel exhaust (standardized to 300µg/m³ of particulate matter with a diameter of 2.5 micrometers or less (PM2.5)) for 2 hours. |
| Diesel Exhaust with LABA/LAMA + ICS | Experimental | Drug: LABA+LAMA+ICS, Other: Diesel ExhaustParticipants will inhale a LABA (vilanterol (25mcg)) + LAMA (umeclidinium (62.5mcg))+ Inhaled Corticosteroid (ICS; fluticasone furoate (100mcg)) medication once daily for 28+ days before sitting in a booth and being exposed to diesel exhaust (300ug/m3 of PM2.5) for 2 hours. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between the ages of 40 to 80
- Mild-to-moderate COPD diagnosis (Global Initiative for Chronic Obstructive Lung Disease stage 1-2) as confirmed by medical history, questionnaires, and spirometry (a test that measures the amount of air one can breathe in and out of the lungs) results
- Spirometry results will be assessed by the study physician to determine eligibility
Key exclusion criteria (5 listed)
- Currently smoking or have been smoking within six months of your screening visit for this study
- Have had an acute exacerbation of COPD (AECOPD) diagnosis within 365 days of the screening visit
- Have a history of asthma or asthma-COPD overlap syndrome
- Existing medical condition or other health concerns as assessed by the study physician
- Pregnant, plan to be pregnant, or breastfeeding during your enrolment in the study. Participants of childbearing potential will be required to have a negative pregnancy test prior to study inclusion.
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 |
|---|---|---|
| LABA+LAMAAlso: Anoro Ellipta1 dose per day (AM) | Drug | Diesel Exhaust with LABA/LAMA, Filtered Air with LABA/LAMA |
| LABA+LAMA+ICSAlso: Trelegy Ellipta1 dose per day (AM) | Drug | Diesel Exhaust with LABA/LAMA + ICS, Filtered Air with LABA/LAMA + ICS |
| Filtered AirExposure to HEPA filtered air, as a control | Other | Filtered Air with LABA/LAMA, Filtered Air with LABA/LAMA + ICS |
| Diesel ExhaustAlso: Traffic Related Air PollutionDiesel exhaust standardized to 300µg/m³ of particulate matter with a diameter of 2.5 micrometers or less (PM2.5). | Other | Diesel Exhaust with LABA/LAMA, Diesel Exhaust with LABA/LAMA + ICS |
Primary outcome
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure effects on inflammatory cells.
Time frame: Comparison of the different arms over the span of 5 months.
Differentially count lung cells.
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure effects on exhaled nitric oxide.
Time frame: Comparison of the different arms over the span of 5 months.
Measurement of fractional exhaled nitric oxide (FeNO).
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure effects on anti-microbial host defense proteins.
Time frame: Comparison of the different arms over the span of 5 months.
Anti-microbial host defense (AMP) matrix, determined from, for example, human neutrophil peptide 1 (HNP1; DEFA1), calprotectin (S100A8/S100A9), cathelicidin antimicrobial peptide/LL-37, Lipocalin-2 (LCN2), and S100 calcium-binding protein A7 (S100A7) in the lungs. And dermcidin (DCD), calprotectin (S100A8/S100A9), cathelicidin antimicrobial peptide/LL-37, and amphiregulin (AREG) in peripheral blood.
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure effects on oxidative stress in the lungs.
Time frame: Comparison of the different arms over the span of 5 months.
Determine oxidative stress (e.g. H2DCFDA) in the lungs.
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure effects on neutrophil extracellular TRAPs (NETs).
Time frame: Comparison of the different arms over the span of 5 months.
Analysis of counts of neutrophil extracellular TRAPs (NETs).
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure effects on lung inflammatory markers.
Time frame: Comparison of the different arms over the span of 5 months.
An inflammation matrix will be generated, including data from RNA and proteins (e.g. serum amyloid A (SAA), c-reactive protein (CRP), chemokine ligand 18 (CCL18) and fibrinogen), in the lungs.
10 secondary outcomes
Inhaled corticosteroids (ICS) and/or diesel exhaust exposure induced modulation of circulating markers of inflammation.
Time frame: Comparison of the different arms over the span of 5 months.
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure induced modulation of circulating cells and inflammatory cellular markers.
Time frame: Comparison of the different arms over the span of 5 months.
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure induced modulation of lung resistance as assessed by oscillometry.
Time frame: Comparison of the different arms over the span of 5 months.
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure effects on lung function.
Time frame: Comparison of the different arms over the span of 5 months.
Effects of inhaled corticosteroids (ICS) and/or diesel exhaust on neutrophil function.
Time frame: Comparison of the different arms over the span of 5 months.
Effects of inhaled corticosteroids (ICS) and/or diesel exhaust on phagocytosis.
Time frame: Comparison of the different arms over the span of 5 months.
Effects of inhaled corticosteroids (ICS) and/or diesel exhaust on the EXACT (and E-RS:COPD) questionnaire.
Time frame: Comparison of the different arms over the span of 5 months.
Effects of inhaled corticosteroids (ICS) and/or diesel exhaust on the mMRC dyspnea scale questionnaire.
Time frame: Comparison of the different arms over the span of 5 months.
Effects of inhaled corticosteroids (ICS) and/or diesel exhaust on the Symptoms and Perception questionnaire.
Time frame: Comparison of the different arms over the span of 5 months.
Effects of inhaled corticosteroids (ICS) and/or diesel exhaust on the Perceived Stress Scale questionnaire.
Time frame: Comparison of the different arms over the span of 5 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
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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.
Christopher Carlsten, MD, MPH principal investigator
University of British Columbia
Neeloffer Mookherjee, PhD principal investigator
University of Manitoba
Shawn Aaron, MD, FRCPC principal investigator
University of Ottawa/Université d'Ottawa
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing LABA+LAMA, LABA+LAMA+ICS and Filtered Air in people with COPD, run by University of British Columbia.
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 5 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: opening soon, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PJ (Parteek) Johal, BCS (604-875-5132, p.johal@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhaled corticosteroid (ICS) and/or diesel exhaust exposure effects on inflammatory cells. (time frame: Comparison of the different arms over the span of 5 months.). The study lists 6 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 27 Mar 2025.