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A Pilot Efficacy Study of Inhaled Albuterol Delivered With Akita Breath Control

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00385359
First received: October 6, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Albuterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on November 24, 2014