Asthma Clinical Trial
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
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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