A Pilot Efficacy Study of Inhaled Albuterol Delivered With Akita Breath Control
Information source: University Health Network, Toronto
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: aerosol drug deposition strategies (Procedure); Albuterol (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Health Network, Toronto Official(s) and/or principal investigator(s): Victor Hoffstein, MD, Principal Investigator, Affiliation: University Health Network, Toronto
Overall contact: Patricia McClean, MSc, Phone: 416-603-5800, Ext: 3438, Email: pmcclean@uhnres.utoronto.ca
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: change in FEV1 expressed as a percent of predicted between baseline and 1 hour post drug administration.
Secondary outcome: duration of effect based on FEV1 at 6 hours post treatment compared to standard treatmentchange in hand tremor compared to standard treatment change in heart rate compared to standard treatment
Detailed description:
Side effects of albuterol (salbutamol)are 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 3. 5 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
participant's 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 rate)will be monitored for 6 hours following drug
administration.
Eligibility
Minimum age: 18 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Locations and Contacts
Patricia McClean, MSc, Phone: 416-603-5800, Ext: 3438, Email: pmcclean@uhnres.utoronto.ca
Toronto Western Hospital - Respiratory Research Lab, Toronto, Ontario M5T 2S8, Canada; Recruiting
Additional Information
Starting date: October 2006
Last updated: October 6, 2006
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