Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06509659
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-07
Brief Title:
Methacholine Challenge Test MCT in Healthy Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Methacholine Challenge Test MCT in Healthy Adults Oscillometry Measured Alone Compared to Oscillometry and FEV1 During the Same Test
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
Knowledge of Methacholine Challenge Test MCT and impedance Oscillometry IOS is limited Only three studies have included adult patients and none of these with healthy controls The three studies have combined IOS and spirometry in the same test although it is not recommended to perform IOS after a test that requires deep breathing eg FEV1 measurement Deep breathing is considered to affect the impedance via reduced tone in the smooth muscle
Detailed Description:
Asthma is a common chronic disease that is characterized by a history of variable respiratory symptoms and variable expiratory airflow limitation and usually associated with airway hyperresponsiveness
In general FEV1 is used to test for airway hyperresponsiveness AHR and a 20 decrease after methacholine challenge test MCT is considered a positive test
There is increasing recognition that the small airways are involved in 40-80 of patients with asthma and the function of these airways is overlooked the silent zone when measuring FEV1 which mainly reflects the function of the central airways
Small airway dysfunction SAD can be assessed by IOS where pressure applied to the airways at a range of frequencies and components of respiratory resistance and reactance are measured Resistance at 5 Hz R5 and 20 Hz R20 respectively represent total airway resistance and proximal airway resistance The difference between these two values can be calculated R5-R20 High R5-R20 and low reactance at 5 Hz X5 indicate the presence of SAD
Knowledge of MCT and IOS is limited Only three studies have included adult patients and none of these with healthy controls These studies have combined IOS and spirometry in the same test although it is not recommended to perform IOS after a test that requires deep breathing eg FEV1 measurement Deep breathing is considered to affect the impedance via reduced tone in the smooth muscle
The investigators have the following objectives for these studies
1 To determine the IOS response to MCT in healthy adults
2 To investigate whether spirometry FEV1 carried out in relation to MCT influences IOS by comparing the IOS response to MCT performed with and without spirometry in healthy adults
In general FEV1 is used to test for airway hyperresponsiveness AHR and a 20 decrease after methacholine challenge test MCT is considered a positive test
There is increasing recognition that the small airways are involved in 40-80 of patients with asthma and the function of these airways is overlooked the silent zone when measuring FEV1 which mainly reflects the function of the central airways
Small airway dysfunction SAD can be assessed by IOS where pressure applied to the airways at a range of frequencies and components of respiratory resistance and reactance are measured Resistance at 5 Hz R5 and 20 Hz R20 respectively represent total airway resistance and proximal airway resistance The difference between these two values can be calculated R5-R20 High R5-R20 and low reactance at 5 Hz X5 indicate the presence of SAD
Knowledge of MCT and IOS is limited Only three studies have included adult patients and none of these with healthy controls These studies have combined IOS and spirometry in the same test although it is not recommended to perform IOS after a test that requires deep breathing eg FEV1 measurement Deep breathing is considered to affect the impedance via reduced tone in the smooth muscle
The investigators have the following objectives for these studies
1 To determine the IOS response to MCT in healthy adults
2 To investigate whether spirometry FEV1 carried out in relation to MCT influences IOS by comparing the IOS response to MCT performed with and without spirometry in healthy adults
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