Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-25 @ 4:14 PM
Study NCT ID:
NCT06614959
Status:
RECRUITING
Last Update Posted:
2025-05-28
First Post:
2024-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Oscillatory Positive Expiratory Pressure (OPEP) Therapy in Patients With COPD
Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Organization:
Study Overview
Official Title:
Assessing the Effects of Oscillatory Positive Expiratory Pressure (OPEP) Therapy on Disease Impact and Respiratory System Dynamics in Patients With COPD: A Prospective Non-Pharmacologic Interventional Cohort Study
Status:
RECRUITING
Status Verified Date:
2025-05
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:
The goal of this non-pharmacologic interventional study is to learn if Oscillatory Positive Expiratory Pressure (OPEP) therapy can improve disease impact and respiratory system dynamics in patients with COPD. The main questions it aims to answer are:
Is OPEP therapy able to improve the impact of cough symptoms as measured on a validated symptom score? Is OPEP therapy able to improve the properties of the lung (called reactance) as measured by oscillometry?
Researchers will compare the results of the same tests performed before and after 4 weeks of OPEP treatment to see if OPEP treatment improves cough symptoms and lung mechanics.
* Participants with COPD will complete in-person baseline tests and will then receive the smart OPEP device.
* These participants will then use the smart OPEP device at home, at least twice a day, for 4 consecutive weeks.
* Finally, these participants will return to complete in-person end-of-study tests.
Is OPEP therapy able to improve the impact of cough symptoms as measured on a validated symptom score? Is OPEP therapy able to improve the properties of the lung (called reactance) as measured by oscillometry?
Researchers will compare the results of the same tests performed before and after 4 weeks of OPEP treatment to see if OPEP treatment improves cough symptoms and lung mechanics.
* Participants with COPD will complete in-person baseline tests and will then receive the smart OPEP device.
* These participants will then use the smart OPEP device at home, at least twice a day, for 4 consecutive weeks.
* Finally, these participants will return to complete in-person end-of-study tests.
Detailed Description:
The objectives of this prospective, non-pharmacologic interventional cohort study are to determine the effect of four consecutive weeks of twice-daily or greater OPEP usage among patients with COPD with a chronic bronchitis (sputum-producing) phenotype on disease impact and on respiratory system dynamics. A 'dose-response' effect of OPEP use will also be investigated.
We hypothesize that a 4-week period of OPEP therapy among eligible patients with COPD with a chronic bronchitis (sputum-producing) phenotype will be associated with improved disease impact scores and airway mechanics.
We hypothesize that a 4-week period of OPEP therapy among eligible patients with COPD with a chronic bronchitis (sputum-producing) phenotype will be associated with improved disease impact scores and airway mechanics.
Study Oversight
Has Oversight DMC:
False
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?: