Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05565430
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2016-05-31
Brief Title:
Vocal Cord Responses During Hyperventilation in Normal Individuals and in Mild and Severe Asthmatics
Sponsor:
Monash Medical Centre
Organization:
Monash Medical Centre
Study Overview
Official Title:
Vocal Cord Responses During Hyperventilation in Normal Individuals and in Mild and Severe
Status:
RECRUITING
Status Verified Date:
2023-10
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 Investigators aim to
1 Study the effect of hyperventilation on the development of paradoxical vocal cord movement PVCM in healthy individuals and in patients with mild and severe asthma
2 Relate PVCM to airway symptoms and measurements of intra- and extra-thoracic airway hyperresponsiveness ET-AHR
3 Evaluate the effects of inhaled anti-cholinergic agents on PVCM induced by hyperventilation
Hypotheses
1 In health PVCM will not occur in response to hyperventilation
2 In asthma PVCM will occur in response to hyperventilation
3 Airway symptoms and ET-AHR will develop in parallel with PVCM
4 Inhaled anticholinergic agents will prevent PVCM induced by hyperventilation
1 Study the effect of hyperventilation on the development of paradoxical vocal cord movement PVCM in healthy individuals and in patients with mild and severe asthma
2 Relate PVCM to airway symptoms and measurements of intra- and extra-thoracic airway hyperresponsiveness ET-AHR
3 Evaluate the effects of inhaled anti-cholinergic agents on PVCM induced by hyperventilation
Hypotheses
1 In health PVCM will not occur in response to hyperventilation
2 In asthma PVCM will occur in response to hyperventilation
3 Airway symptoms and ET-AHR will develop in parallel with PVCM
4 Inhaled anticholinergic agents will prevent PVCM induced by hyperventilation
Detailed Description:
Specific aims
Project 1 - Acute hyperventilation in normal subjects and asthmatics
Aim 11 To measure PVCM by endoscopy in response to a single period of hyperventilation in normal subjects and asthmatics
Aim 12 To relate PVCM to symptoms in both groups Aim 13 To relate PVCM to bronchial and ET-AHR before and after acute hyperventilation
Project 2 - Chronic hyperventilation and the effect on vocal cord movements in asthmatic subjects
Aim 21 To measure PVCM by endoscopy in response to multiple periods of hyperventilation twice daily over 2 weeks in normal subjects and asthmatics
Aim22 To relate PVCM to symptoms in both groups Aim 21 To relate PVCM to bronchial and ET-AHR before and after chronic hyperventilation
Project 3 a - Effects of anticholinergic medication on PVCM
Aim 31 Determine the effect of anti-cholinergic inhaled medications on PVCM induced by hyperventilation
Project 3 b - PVCM during exercise and the effects of anticholinergic medication on PVCM If no PVCM is detected in project 1 and 2 as an alternative strategy the Investigators will examine PVCM that has been shown to occur in severe asthma in response to exercise The effect of anti-cholinergic inhaled medications will then be examined in this model
Significance
Dysfunctional breathing may be a mechanism whereby symptomatic PVCM develops in asthma but not in health The proposed studies will enhance the Investigators understanding of the role played by dysfunctional breathing in the pathogenesis of this distressing condition and may provide a rationale for targeted therapies
Project 1 - Acute hyperventilation in normal subjects and asthmatics
Aim 11 To measure PVCM by endoscopy in response to a single period of hyperventilation in normal subjects and asthmatics
Aim 12 To relate PVCM to symptoms in both groups Aim 13 To relate PVCM to bronchial and ET-AHR before and after acute hyperventilation
Project 2 - Chronic hyperventilation and the effect on vocal cord movements in asthmatic subjects
Aim 21 To measure PVCM by endoscopy in response to multiple periods of hyperventilation twice daily over 2 weeks in normal subjects and asthmatics
Aim22 To relate PVCM to symptoms in both groups Aim 21 To relate PVCM to bronchial and ET-AHR before and after chronic hyperventilation
Project 3 a - Effects of anticholinergic medication on PVCM
Aim 31 Determine the effect of anti-cholinergic inhaled medications on PVCM induced by hyperventilation
Project 3 b - PVCM during exercise and the effects of anticholinergic medication on PVCM If no PVCM is detected in project 1 and 2 as an alternative strategy the Investigators will examine PVCM that has been shown to occur in severe asthma in response to exercise The effect of anti-cholinergic inhaled medications will then be examined in this model
Significance
Dysfunctional breathing may be a mechanism whereby symptomatic PVCM develops in asthma but not in health The proposed studies will enhance the Investigators understanding of the role played by dysfunctional breathing in the pathogenesis of this distressing condition and may provide a rationale for targeted therapies
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