Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465413
Status:
COMPLETED
Last Update Posted:
2007-11-14
First Post:
2007-04-24
Brief Title:
Bronchodilatation Effects of a Small Volume Spacer Used With a Metered-Dose Inhaler
Sponsor:
Mackay Memorial Hospital
Organization:
Mackay Memorial Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-09
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:
MDI
Brief Summary:
The purpose of the present study is to determine whether use of a small volume spacer is associated with better bronchodilatation in an unselected population of patients with documented reversible airflow limitations
Detailed Description:
Administration of bronchodilator drugs with metered-dose inhalers MDIs is difficult for some patients because the timing of the spray and the inhalation must be coordinated exactly Use of spacers seems to improve delivery in these patients It is not clear however if there is any advantage to a spacer for patients who are able to use an MDI with correct technique
The purpose of the present study is to determine whether use of a small volume spacer is associated with better bronchodilatation in an unselected population of patients with documented reversible airflow limitations The intervention in the first part of the study is use of an MDI with or without a spacer to deliver a bronchodilator 2 puffs 04 mg of fenoterol Spirometry is performed before and after the inhalation
The second part of the study is conducted identically to the first with the same conditions and variables but with the addition of rinsing the mouth with 100 mL of water after inhaling the bronchodilator but before the second spirometry measurement
The outcome to be measured is the increase in forced expiratory volume in 1 second FEV1 and forced expiratory flow rate FEF25-75
The purpose of the present study is to determine whether use of a small volume spacer is associated with better bronchodilatation in an unselected population of patients with documented reversible airflow limitations The intervention in the first part of the study is use of an MDI with or without a spacer to deliver a bronchodilator 2 puffs 04 mg of fenoterol Spirometry is performed before and after the inhalation
The second part of the study is conducted identically to the first with the same conditions and variables but with the addition of rinsing the mouth with 100 mL of water after inhaling the bronchodilator but before the second spirometry measurement
The outcome to be measured is the increase in forced expiratory volume in 1 second FEV1 and forced expiratory flow rate FEF25-75
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