Ignite Creation Date:
2024-07-17 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495047
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-06-30
Brief Title:
Assessing Optimal Inhaler Strategies During Acute Exacerbations of COPD AECOPDs Using Oscillometry
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
Assessment of Optimal Inhaler Therapy Strategies in the Management of Acute Exacerbations of COPD AECOPDs Using Oscillometry A Cross-Sectional Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic Obstructive Pulmonary Disease COPD is a persistent lung disease that makes it very difficult to breathe The airways and the normally spongy lungs themselves are affected The main treatment is puffers some which are long-acting to control persistent symptoms and some which are short-acting rescue puffers when suddenly feeling short-of-breath Beyond persisting breathlessness at rest people with COPD can also experience dangerous lung-attacks which can require urgent care visits or even hospitalization for treatment Amazingly although COPD is the third leading cause of death worldwide and COPD lung-attacks are a leading cause of hospitalization in Canada investigators are still unsure which combination of puffers is most effective at treating lung-attacks
The main objective is to determine which puffer treatment combination just short-acting or both short-acting and long-acting best opens up the lungs to airflow during COPD lung-attacks
A test called oscillometry which requires only quiet breathing and is so safe that it is regularly used in children toddlers and even infants will be used to measure lung function changes All eligible people with COPD receiving urgent lung-attack treatment who agree to participate will perform three rounds of oscillometry before any puffers after only short-acting puffers and finally after long-acting puffers are also added on Any potential evidence of side effects will be collected from the chart Oscillometry tests will be compared to see which puffer strategy best improves flow in the airways
Part of the reason why this has not been well-studied so far is that the standard breathing test spirometry requires multiple rounds of forceful breathing which is very difficult even distressing for many people with COPD at rest let alone during a lung-attack No studies have ever properly studied which puffer strategy is most effective for lung-attacks The investigators have experience and expertise with oscillometry the most appropriate test in this setting to answer this pressing question
This research addresses an important treatment knowledge gap for this very common lung disease These results could influence how patients with COPD around the world are treated during lung-attacks so that they can breathe better sooner
The main objective is to determine which puffer treatment combination just short-acting or both short-acting and long-acting best opens up the lungs to airflow during COPD lung-attacks
A test called oscillometry which requires only quiet breathing and is so safe that it is regularly used in children toddlers and even infants will be used to measure lung function changes All eligible people with COPD receiving urgent lung-attack treatment who agree to participate will perform three rounds of oscillometry before any puffers after only short-acting puffers and finally after long-acting puffers are also added on Any potential evidence of side effects will be collected from the chart Oscillometry tests will be compared to see which puffer strategy best improves flow in the airways
Part of the reason why this has not been well-studied so far is that the standard breathing test spirometry requires multiple rounds of forceful breathing which is very difficult even distressing for many people with COPD at rest let alone during a lung-attack No studies have ever properly studied which puffer strategy is most effective for lung-attacks The investigators have experience and expertise with oscillometry the most appropriate test in this setting to answer this pressing question
This research addresses an important treatment knowledge gap for this very common lung disease These results could influence how patients with COPD around the world are treated during lung-attacks so that they can breathe better sooner
Detailed Description:
Three sets of carefully timed oscillometry and dyspnea score measurements will be performed 1 at baseline before the participant receives their scheduled dose of LABD and roughly 4 hours following a scheduled dose of SABD 2 between 15-20 min after having received their next scheduled dose of SABD and just preceding their next scheduled dose of LABD SABD only and 3 after having received the scheduled dose of LABD and between 25-35min of the most recent SABD administration LABD SABD such that there is overlap in the time window of SABD and LABD onset at the time of the third set of testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None