Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552364
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-03-28
Brief Title:
Air Pollution and Inhaled Corticosteroids in COPD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Air Pollution and Inhaled Corticosteroids in COPD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APIC
Brief 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
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 participants 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 eg 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
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 participants 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None