Ignite Creation Date:
2024-05-06 @ 8:49 AM
Last Modification Date:
2024-10-26 @ 12:05 PM
Study NCT ID:
NCT02822859
Status:
COMPLETED
Last Update Posted:
2017-10-26
First Post:
2016-06-30
Brief Title:
A Comparison of Three Nebulizers for Standard Clinical and Research Use in Methacholine Challenge Testing
Sponsor:
University of Saskatchewan
Organization:
University of Saskatchewan
Study Overview
Official Title:
A Comparison of Three Nebulizers for Standard Clinical and Research Use in Methacholine Challenge Testing
Status:
COMPLETED
Status Verified Date:
2017-10
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 study will assess three different nebulizers for use in methacholine challenge testing in order to determine if the Aeroneb Solo would make a suitable replacement for the long-used and now obsolete Wright and Bennett-Twin nebulizers Results from each device will be compared to evaluate whether current guidelines for the methacholine challenge should be updated for superior standardization
Detailed Description:
Sixty asthmatics 20 at each testing site University of Saskatchewan McMaster University Laval University will be recruited to undergo this randomized triple cross-over study Three nebulizers will be tested the Wright the Bennett-Twin and the new Aeroneb Solo
Breakdown of study procedure Participants will undergo three potentially four methacholine challenges one with each nebulizer in randomized order An additional methacholine challenge may be performed for screening purposes if the participant has not undergone methacholine challenge testing in one of the participating labs in the previous 6 months The screening challenge will be performed with the standard nebulizer used at the given testing site ie the Wright or the Bennett-Twin
The methacholine challenges performed with the Wright and Bennett-Twin nebulizers will follow the two-minute tidal breathing protocol as outlined in the 1999 American Thoracic Society Guidelines for Methacholine Challenge Testing The testing protocol used with the Aeroneb solo will be identical save for a 1 min inhalation period instead of 2 min Each challenge will be stopped when a participants forced expiratory volume in 1 second FEV1 drops at least 20 This will allow for the determination of the participants PC20 provocative concentration of methacholine causing a 20 fall in FEV1 which will subsequently be converted to a PD20 provocative dose value A minimum 24-hour washout period between challenges will be enforced
Breakdown of study procedure Participants will undergo three potentially four methacholine challenges one with each nebulizer in randomized order An additional methacholine challenge may be performed for screening purposes if the participant has not undergone methacholine challenge testing in one of the participating labs in the previous 6 months The screening challenge will be performed with the standard nebulizer used at the given testing site ie the Wright or the Bennett-Twin
The methacholine challenges performed with the Wright and Bennett-Twin nebulizers will follow the two-minute tidal breathing protocol as outlined in the 1999 American Thoracic Society Guidelines for Methacholine Challenge Testing The testing protocol used with the Aeroneb solo will be identical save for a 1 min inhalation period instead of 2 min Each challenge will be stopped when a participants forced expiratory volume in 1 second FEV1 drops at least 20 This will allow for the determination of the participants PC20 provocative concentration of methacholine causing a 20 fall in FEV1 which will subsequently be converted to a PD20 provocative dose value A minimum 24-hour washout period between challenges will be enforced
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