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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Albuterol

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