Air Pollution and Inhaled Corticosteroids in COPD

NCT06552364 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-03-27

No results posted yet for this study

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06552364 on ClinicalTrials.gov