Recruiting

Inhaled Albuterol

Sponsor:

University Health Network, Toronto

Code:

NCT00385359

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

aerosol drug deposition strategies

Albuterol

Study Details

Brief 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.

Conditions

Asthma

Study ID

NCT00385359

Start date

Oct, 2006

Status verified date

Oct, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

aerosol drug deposition strategies

Albuterol

Primary outcome measure

  • change in FEV1 expressed as a percent of predicted between baseline and 1 hour post drug administration. [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Patricia McClean, MSc

416-603-5800pmcclean@uhnres.utoronto.ca

Pearl Latty, BSc

416-603-5489platty@uhnres.utoronto.ca

Locations

Toronto Western Hospital - Respiratory Research Lab

Recruiting

Toronto, Ontario, Canada, M5T 2S8

More Information

Sponsor

University Health Network, Toronto

Last update posted

Oct 9, 2006

Last verified

Oct, 2006

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2006-10-09.