Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05814484
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-19
First Post:
2023-03-22
Brief Title:
Role of Inhaler Adherence and Blood Eosinophil Count in Exacerbations of COPD
Sponsor:
University of Leicester
Organization:
University of Leicester
Study Overview
Official Title:
An Observational Cohort Study of Inhaler Adherence and Blood Eosinophil Count in Exacerbations of Chronic Obstructive Pulmonary Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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:
INCLINE
Brief Summary:
This is an observational study examining inhaler adherence and subsequent changes in blood eosinophil count in exacerbations of Chronic obstructive pulmonary disease COPD population
The study will run for 6 months as an observation period Passive inhaler adherence monitoring will be done electronically via inhaler sensors connected to mobile Apps and collecting symptoms questionnaires diary of exacerbation events and trial visits predominantly in remote fashion It will explore the feasibility of digital platform in clinical practice to collect the adherence data along with exacerbation events
The study will run for 6 months as an observation period Passive inhaler adherence monitoring will be done electronically via inhaler sensors connected to mobile Apps and collecting symptoms questionnaires diary of exacerbation events and trial visits predominantly in remote fashion It will explore the feasibility of digital platform in clinical practice to collect the adherence data along with exacerbation events
Detailed Description:
How Chronic Obstructive Pulmonary Disease COPD affects patients varies greatly among individuals The concept of treatable traits which identifies factors within an individual to allow targeted treatment has altered management strategies The most commonly used biomarker for exacerbations of COPD is the blood eosinophil count BEC which tends to indicate a higher risk of exacerbations but importantly is a biomarker of treatment response for corticosteroids
Current pharmacological treatment for COPD is predominately based around inhaled therapy in the form of bronchodilators and inhaled corticosteroids ICS therapy
However almost half of the COPD population have been shown to poorly follow the prescribed inhaled therapy This is important as a non-adherent trait may impact on BEC and result in unnecessary treatment escalation increased risk to higher risk individuals eg patients with high BEC and lack of intervention around inhaler adherence
Recent developments of digital platforms could potentially address this by capturing objective adherence data unrecorded exacerbation events or if possible anticipating the latter
In summary it is important to align inhaler adherence in conjunction with established biomarker as is likely to help gain maximum benefit and better target interventions In this study the investigators propose the electronic monitoring of adherence and exacerbation reporting data along with the reflected changes in biomarkers and disease outcomes to lead a meaningful treatable trait approach in real-life setting
Current pharmacological treatment for COPD is predominately based around inhaled therapy in the form of bronchodilators and inhaled corticosteroids ICS therapy
However almost half of the COPD population have been shown to poorly follow the prescribed inhaled therapy This is important as a non-adherent trait may impact on BEC and result in unnecessary treatment escalation increased risk to higher risk individuals eg patients with high BEC and lack of intervention around inhaler adherence
Recent developments of digital platforms could potentially address this by capturing objective adherence data unrecorded exacerbation events or if possible anticipating the latter
In summary it is important to align inhaler adherence in conjunction with established biomarker as is likely to help gain maximum benefit and better target interventions In this study the investigators propose the electronic monitoring of adherence and exacerbation reporting data along with the reflected changes in biomarkers and disease outcomes to lead a meaningful treatable trait approach in real-life setting
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