Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04606394
Status:
COMPLETED
Last Update Posted:
2023-05-08
First Post:
2020-10-19
Brief Title:
Peak Inspiratory Flow and Dry Powder Inhaler Performance in COPD
Sponsor:
Pulmonary Research Institute of Southeast Michigan
Organization:
Pulmonary Research Institute of Southeast Michigan
Study Overview
Official Title:
Peak Inspiratory Flow PIF and Dry Powder Inhaler DPI Performance in Chronic Obstructive Pulmonary Disease COPD
Status:
COMPLETED
Status Verified Date:
2020-12
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 purpose of the study is to determine whether PIF is clinically important when using the Ellipta DPI device In addition the study will validate the bestmost clinically appropriate way to perform a PIF maneuver to determine the testing capabilities of the preferred PIF maneuver and to relate this PIF measurement to meaningful clinical outcomes in COPD patients
Detailed Description:
Study Design and Methods Rationale
The expected FEV1 response to a bronchodilator is uncertain as multiple factors influence this measure including severity of disease day to day variability varying reversibility in COPD patients the delivery of the drug to a patient and the effectiveness of the medication delivered Thus the measurement of an acute bronchodilator response after delivering a long acting bronchodilator may not identify whether a medication has been effectively delivered to a patient
However if a long acting bronchodilator has not been effectively delivered to the lung then subsequent delivery of a short acting bronchodilator should produce a significant additional bronchodilator response On the other hand if a long acting bronchodilator has been effectively delivered to the lung then subsequent delivery of a short acting bronchodilator should not produce any further significant bronchodilation
Based on this rationale comparison of the acute bronchodilator response to a short acting bronchodilator after receiving a long acting should identify whether drug delivery is ineffective in a selected patient population irrespective of baseline FEV1 and of any partial response to the long acting bronchodilator Comparison of the short acting bronchodilator measurement between patient groups with differing PIF thresholds should identify whether PIF has an impact of drug delivery of a long acting bronchodilator via a DPI
Open label design comparing the acute bronchodilator response after delivery of a long acting bronchodilator via Ellipta DPI in patients with normal suboptimal and minimal PIF
The expected FEV1 response to a bronchodilator is uncertain as multiple factors influence this measure including severity of disease day to day variability varying reversibility in COPD patients the delivery of the drug to a patient and the effectiveness of the medication delivered Thus the measurement of an acute bronchodilator response after delivering a long acting bronchodilator may not identify whether a medication has been effectively delivered to a patient
However if a long acting bronchodilator has not been effectively delivered to the lung then subsequent delivery of a short acting bronchodilator should produce a significant additional bronchodilator response On the other hand if a long acting bronchodilator has been effectively delivered to the lung then subsequent delivery of a short acting bronchodilator should not produce any further significant bronchodilation
Based on this rationale comparison of the acute bronchodilator response to a short acting bronchodilator after receiving a long acting should identify whether drug delivery is ineffective in a selected patient population irrespective of baseline FEV1 and of any partial response to the long acting bronchodilator Comparison of the short acting bronchodilator measurement between patient groups with differing PIF thresholds should identify whether PIF has an impact of drug delivery of a long acting bronchodilator via a DPI
Open label design comparing the acute bronchodilator response after delivery of a long acting bronchodilator via Ellipta DPI in patients with normal suboptimal and minimal PIF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None