A Pilot Efficacy Study of Inhaled Albuterol Delivered With Akita Breath Control - Full Text View

Sponsored by:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00385359

Purpose

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.

Condition	Intervention	Phase
Asthma	Procedure: aerosol drug deposition strategies Drug: Albuterol	Phase IV

MedlinePlus related topics: Asthma Tremor

Drug Information available for: Albuterol sulfate Albuterol Levalbuterol hydrochloride Levalbuterol tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment, Efficacy Study
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

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

change in FEV1 expressed as a percent of predicted between baseline and 1 hour post drug administration.

Secondary Outcome Measures:

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

Estimated Enrollment:	10
Study Start Date:	October 2006

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

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00385359

Contacts

Contact: Patricia McClean, MSc	416-603-5800 ext 3438	pmcclean@uhnres.utoronto.ca
Contact: Pearl Latty, BSc	416-603-5489	platty@uhnres.utoronto.ca

Locations

Canada, Ontario
Toronto Western Hospital - Respiratory Research Lab	Recruiting
Toronto, Ontario, Canada, M5T 2S8

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:

Victor Hoffstein, MD

University Health Network, Toronto

More Information

Study ID Numbers:	IA-01
Study First Received:	October 6, 2006
Last Updated:	October 6, 2006
ClinicalTrials.gov Identifier:	NCT00385359
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Albuterol
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Bronchial Diseases
Immune System Diseases
Adrenergic beta-Agonists
Physiological Effects of Drugs
Anti-Asthmatic Agents

Reproductive Control Agents
Adrenergic Agonists
Pharmacologic Actions
Tocolytic Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009