Air Pollution and Inhaled Corticosteroids in COPD
NCT06552364 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2025-03-27
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. 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.
Conditions
Interventions
- DRUG
-
LABA+LAMA
1 dose per day (AM)
- DRUG
-
LABA+LAMA+ICS
1 dose per day (AM)
- OTHER
-
Filtered Air
Exposure to HEPA filtered air, as a control
- OTHER
-
Diesel Exhaust
Diesel exhaust standardized to 300µg/m³ of particulate matter with a diameter of 2.5 micrometers or less (PM2.5).
Sponsors & Collaborators
-
University of Calgary
collaborator OTHER -
University of Ottawa
collaborator OTHER -
University of Manitoba
collaborator OTHER -
University of North Carolina, Chapel Hill
collaborator OTHER -
University of British Columbia
lead OTHER
Principal Investigators
-
Christopher Carlsten, MD, MPH · University of British Columbia
-
Neeloffer Mookherjee, PhD · University of Manitoba
-
Shawn Aaron, MD, FRCPC · University of Ottawa/Université d'Ottawa
-
Janice Leung, MD, FRCPC · University of British Columbia
-
Christopher F Rider, PhD · University of British Columbia
-
Neil Alexis, PhD · University of North Carolina, Chapel Hill
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-01
- Primary Completion
- 2026-12-31
- Completion
- 2028-12-31
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