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Corticosteroid

Diesel Exhaust + Corticosteroids for Glucocorticoid Resistance (DIGR Trial)

Phase 4
Recruiting
Led By Chris Carlsten, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have physician-diagnosed asthma confirmed by the study physician examination, spirometry, methacholine challenge provocative concentration causing a 20% fall (PC20) of <16 mg/mL, and questionnaires during a screening visit
Aged 19-49
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline versus 6 hours
Awards & highlights

DIGR Trial Summary

This trial is studying the effects of diesel exhaust and an inhaled corticosteroid on lung inflammation.

Who is the study for?
This trial is for adults aged 19-49 with physician-diagnosed asthma, confirmed through various tests and questionnaires. Participants must not have a relevant heart condition, be pregnant or breastfeeding, use certain medications regularly, have a high body mass index (>35), smoke or vape, or be on corticosteroids in the past 6 months.Check my eligibility
What is being tested?
The study examines how diesel exhaust affects lung inflammation and if it reduces the effectiveness of an inhaled corticosteroid (Budesonide) in asthmatics. Volunteers will inhale either placebo or Budesonide before spending two hours breathing filtered air or diluted diesel exhaust to assess changes.See study design
What are the potential side effects?
Potential side effects may include increased lung inflammation from diesel exposure and typical reactions to Budesonide such as throat irritation, coughing, dry mouth/nose/throat, voice changes, and possible infection risk.

DIGR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My asthma has been confirmed by tests and doctor's evaluation.
Select...
I am between 19 and 49 years old.

DIGR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline versus 6 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline versus 6 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in DNA methylation, mRNA and protein expression attributable to diesel exhaust and inhaled corticosteroid
Secondary outcome measures
Modification by variants in genes governing inflammation and responses to oxidative stress after DE exposure and ICS.

Side effects data

From 2019 Phase 4 trial • 129 Patients • NCT02019758
12%
esophageal candidiasis
3%
oral candidiasis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Viscous Budesonide (OVB)
Active Fluticasone MDI

DIGR Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Budesonide and Diesel ExhaustExperimental Treatment2 Interventions
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.
Group II: Placebo and Diesel ExhaustActive Control2 Interventions
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.
Group III: Budesonide and Filtered AirActive Control2 Interventions
Volunteers will inhale 1.6mg of budesonide before sitting in a booth and being exposed to HEPA filtered air for 2 hours.
Group IV: Placebo and Filtered AirPlacebo Group2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Budesonide
2017
Completed Phase 4
~13050

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,453,387 Total Patients Enrolled
AllerGen NCE Inc.Industry Sponsor
8 Previous Clinical Trials
346 Total Patients Enrolled
University of British ColumbiaLead Sponsor
1,416 Previous Clinical Trials
2,467,008 Total Patients Enrolled

Media Library

Budesonide (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03615742 — Phase 4
Glucocorticoid Resistance Research Study Groups: Placebo and Filtered Air, Placebo and Diesel Exhaust, Budesonide and Diesel Exhaust, Budesonide and Filtered Air
Glucocorticoid Resistance Clinical Trial 2023: Budesonide Highlights & Side Effects. Trial Name: NCT03615742 — Phase 4
Budesonide (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03615742 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the Food and Drug Administration authorize Diesel Exhaust as a legitimate therapeutic resource?

"The level of safety associated with Diesel Exhaust has been granted a score of 3 due to the completion of Phase 4 trials, which indicates that it is approved for use."

Answered by AI

What is the current enrollment figure for this research endeavor?

"Affirmative, the clinical trial is actively enrolling. The initial posting was on December 1st 2018 and it has since been updated November 10th 2022. This study aims to involve 30 individuals at one location."

Answered by AI

What medical conditions are typically treated with Diesel Exhaust?

"Diesel Exhaust can be leveraged to help patients manage their acute coryza, proteinuria, and nasal congestion."

Answered by AI

Is the enrollment period still open for this medical trial?

"According to the clinicaltrials.gov website, this medical study is actively recruiting participants with a start date of December 1st 2018 and last update on November 10th 2022."

Answered by AI

Are there other research efforts that have focused on Diesel Exhaust?

"At present, 31 scientific studies are being conducted to further explore Diesel Exhaust. Of those trials, 10 are in the final phase of development and can be found globally at 990 different locations with a majority located in Xi'an, Shaanxi."

Answered by AI

Does this research project accept participants?

"This research is seeking 30 eligible participants aged 19-49 with diagnosed metabolic or congenital disorders."

Answered by AI

Are octogenarians within the qualifying parameters for this experiment?

"This medical trial seeks participants with an age between 19 and 49 years."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Diesel Exhaust Induces Glucocorticoid Resistance
Christopher Carlsten 2018. "Diesel Exhaust Induces Glucocorticoid Resistance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03615742.
~7 spots leftby Dec 2025
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