A Phase 4 interventional study of Placebo and Budesonide in Exposure to Pollution and Glucocorticoid Resistance, sponsored by University of British Columbia. Recruiting at 1 site in Canada. Open to participants aged 19 Years to 49 Years. Per ClinicalTrials.gov, last updated 2024-07-24.
Sponsored by University of British Columbia · Phase 4, Interventional, and Prevention
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The investigators are studying the effects of exposure to diesel exhaust on lung inflammation in the presence and absence of an inhaled corticosteroid. Although data is mixed, studies show that asthmatics have increased lung inflammation and worse symptoms during periods of higher air pollution despite taking their anti-inflammatory corticosteroid medication. One possible reason is that air pollution exposure may decrease the ability of corticosteroids to combat inflammation.
To test this volunteers will inhale either a placebo or a corticosteroid, before sitting in an exposure booth for 2 hours breathing either filtered air or diluted diesel exhaust. Samples will be collected before and after exposure to analyze the effects of budesonide and diesel exhaust exposure.
Hypothesis:
Acute exposure to DE reduces ICS-inducible gene expression in vivo in asthmatics, in part through effects on epigenetic processes.
Justification:
Air pollution exposure correlates with increased use of ICS inhalers in asthmatics, suggesting that ICS offer less control during periods of higher air pollution. As genes induced by ICS are critical in reducing inflammatory messenger ribonucleic acid (mRNA) and protein expression, the investigators have chosen to focus on the effects of DE on ICS-inducible gene expression as our primary endpoint.
Research Method:
To test this the effects of air pollution exposure on a corticosteroid, volunteers will inhale either a placebo (inhaler containing no medication) or budesonide (1.6mg), before sitting in our exposure booth for 2 hours breathing either filtered air (as a control) or diluted diesel exhaust (standardized to 300µg/m³ of particulate matter with a diameter of 2.5 micrometers or less).
Volunteers will visit our lab four different times to be exposed to: 1) placebo \& filtered air, 2) placebo \& diesel exhaust, 3) corticosteroid and filtered air, and 4) corticosteroid and diesel exhaust. Investigators can then compare responses to each of these combinations of exposures.
Investigators will take blood samples before and after volunteers complete each of these exposures to track how they affect the body. Six hours after placebo or budesonide inhalation a research bronchoscopy will be performed during which a very thin flexible tube will be inserted through the mouth and down into lungs to collect samples from each volunteer.
Bronchoalveolar lavage, bronchial washes, bronchial brushes and tissue biopsies will be obtained for analysis of gene expression and epigenetic endpoints. Nasal lavage samples will also be collected to examine responses in the upper airways and blood and urine will be studied to examine systemic responses. Spirometry will be used to assess effects on airway function.
25 studies on the registry are indexed under Glucocorticoid Receptor Deficiency; 2 are open to participants now.
This study's planned enrollment of 30 is below the median of 45 across 16 interventional studies indexed under Glucocorticoid Receptor Deficiency.
Browse Glucocorticoid Receptor Deficiency studies →University of British Columbia is the lead sponsor of 1,340 studies on the registry; 260 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Volunteers will use an inhaler that does not contain any medication, before sitting in a booth and being exposed to high-efficiency particulate air (HEPA) filtered air for 2 hours.
Other: Placebo · Other: Filtered Air
Volunteers will inhale 1.6mg of budesonide before sitting in a booth and being exposed to HEPA filtered air for 2 hours.
Drug: Budesonide · Other: Filtered Air
Volunteers will use an inhaler that does not contain any medication, before sitting in a booth and being exposed to 300µg/m³ concentration of diesel exhaust for 2 hours.
Other: Placebo · Other: Diesel Exhaust
Volunteers will inhale 1.6mg of budesonide before sitting in a booth and being exposed to 300µg/m³ concentration of diesel exhaust for 2 hours.
Drug: Budesonide · Other: Diesel Exhaust
Inhalation of air through a Turbuhaler that contains no medication, as a control.
1.6mg of budesonide from a Turbuhaler.
Also known as: Pulmicort
Exposure to HEPA filtered air, as a control.
Diesel exhaust standardized to 300µg/m³ of particulate matter with a diameter of 2.5 micrometers or less (PM2.5).
Also known as: Traffic Related Air Pollution
Change in DNA methylation, mRNA and protein expression attributable to diesel exhaust and inhaled corticosteroid
EPIC arrays and RNA Seq will be used to determine effect of exposure(s)
Time frame: Baseline versus 6 hours
Modification by variants in genes governing inflammation and responses to oxidative stress after DE exposure and ICS.
Genotypes will be assessed using Applied Biosystems Axiom Precision Medicine Research arrays, with validation by polymerase chain reaction assay (PCR). The data generated will be used to generate a gene score (single value for each participant) which will be used for statistical interaction analysis.
Time frame: Baseline versus 6 hours
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2018 (actual). Primary completion is estimated for Dec 2025, 84 months after the start.
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Studies of the drug tested here: Budesonide
Glucocorticoid Receptor Deficiency →
University of British Columbia →