Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385359
Status:
UNKNOWN
Last Update Posted:
2006-10-09
First Post:
2006-10-06
Brief Title:
A Pilot Efficacy Study of Inhaled Albuterol Delivered With Akita Breath Control
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Pilot Efficacy Study of Inhaled Albuterol Delivered With Akita Breath Control and Pari Nebulization for the Treatment of Adults With Moderate Asthma
Status:
UNKNOWN
Status Verified Date:
2006-10
Last Known Status:
RECRUITING
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:
Albuterol salbutamol is a widely used asthma medication but is associated with undesirable side effects such as shakiness and increased heart rate Targeted delivery of albuterol to area of lungs where it has most effect would require a lower total dose to produce the same beneficial effects while reducing the side effects
It is anticipated that only 113th to 125th of the standard nebulized dose of albuterol will be required to attain same bronchodilator response as a standard nebulizer treatment as determined by lung function measurement and that the reduced dose will significantly reduce side effects as determined by hand tremor and heart rate
It is anticipated that only 113th to 125th of the standard nebulized dose of albuterol will be required to attain same bronchodilator response as a standard nebulizer treatment as determined by lung function measurement and that the reduced dose will significantly reduce side effects as determined by hand tremor and heart rate
Detailed Description:
Side effects of albuterol salbutamolare directly related to the dose delivered and absorbed into blood stream By controlling aerosol delivery dose delivered site of deposition amount of drug absorption can be determined and thus the magnitude of the side effects Delivery and deposition of aerosols are determined by both aerosol characteristics size and timing of delivery and breathing characteristics breath size flow rate and breathholding Data supports the theory that if a high dose of albuterol can be deposited in the larger airway generations and prevented from entering the pulmonary circulation from the lung periphery that this will result in the largest magnitude of bronchodilator response with the lowest circulatory absorbance
This is a pilot study in 10 adults with moderate asthma there are no investigational drugs or devices It is an investigation of a strategy to maximize response to an approved drug while minimizing side effects The investigational strategies will deposit less than 25 of the standard nebulized dose in the airways This will be accomplished by pairing a Pari eFlow nebulizer configured to deliver particle sizes of 35 to 6 microns with an Akita delivery system programmed to deliver the drug as either a late or early bolus during inspiration The Akita is programmed with a specific breathing pattern based on participants lung function tests at screening
Moderate asthmatics with bronchodilator response 20 improvement in FEV1 will be selected Treatments will be administered on separate days 1-7 days apart Following baseline measurements 1 of 5 randomized aerosol treatments will be administered Efficacy FEV1 and side effects tremor and heart ratewill be monitored for 6 hours following drug administration
This is a pilot study in 10 adults with moderate asthma there are no investigational drugs or devices It is an investigation of a strategy to maximize response to an approved drug while minimizing side effects The investigational strategies will deposit less than 25 of the standard nebulized dose in the airways This will be accomplished by pairing a Pari eFlow nebulizer configured to deliver particle sizes of 35 to 6 microns with an Akita delivery system programmed to deliver the drug as either a late or early bolus during inspiration The Akita is programmed with a specific breathing pattern based on participants lung function tests at screening
Moderate asthmatics with bronchodilator response 20 improvement in FEV1 will be selected Treatments will be administered on separate days 1-7 days apart Following baseline measurements 1 of 5 randomized aerosol treatments will be administered Efficacy FEV1 and side effects tremor and heart ratewill be monitored for 6 hours following drug administration
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