A Pilot Efficacy Study of Inhaled Albuterol Delivered With Akita Breath Control
1 other identifier
interventional
10
1 country
1
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 1/13th to 1/25th 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 6, 2006
CompletedFirst Posted
Study publicly available on registry
October 9, 2006
CompletedOctober 9, 2006
October 1, 2006
October 6, 2006
October 6, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
change in FEV1 expressed as a percent of predicted between baseline and 1 hour post drug administration.
Secondary Outcomes (3)
duration of effect based on FEV1 at 6 hours post treatment compared to standard treatment
change in hand tremor compared to standard treatment
change in heart rate compared to standard treatment
Interventions
Eligibility Criteria
You may qualify if:
- Male or female aged 18-60 years
- Moderate asthma with baseline FEV1 40-75% predicted
- Previous use of albuterol (salbutamol)
- At least 20% improvement in FEV1 following 2.5 mg albuterol (salbutamol) delivered by nebulizer
- O2 saturation \> 90%
- Non-smoker for \> 6 months
You may not qualify if:
- Upper respiratory tract infection or asthma exacerbation within 14 days of screening
- Clinically significant abnormal chest radiograph
- History of cardiovascular disorder including coronary insufficiency, cardiac arrhythmias or hypertension
- Unable to tolerate bronchodilator withdrawal
- Known hypersensitivity to albuterol (salbutamol)
- Change in asthma treatment regimen in past 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto Western Hospital - Respiratory Research Lab
Toronto, Ontario, M5T 2S8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Victor Hoffstein, MD
University Health Network, Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 6, 2006
First Posted
October 9, 2006
Study Start
October 1, 2006
Last Updated
October 9, 2006
Record last verified: 2006-10