Official Title

The Various Effects of Gaseous Albuterol on Serum Lactate
  • Phase

  • Study Type

  • Study Participants

Empirical data from physician observation indicates an increase in serum lactate in acute asthmatic patients being treated with inhaled albuterol therapy.

It is not clear if this increased serum lactate is in response to a physiological response to the asthmatic process or from the albuterol treatment.

This study is designed to determine if administration of inhaled albuterol increases serum lactate in healthy subjects.
Approximately 30 healthy volunteers will be randomized to Albuterol or placebo. We powered our study to detect a difference of 0.5 mmol/L, but hypothesize that the difference will be greater than 1.0 mmol/L.

All volunteer subjects will sign a written consent, approved by the Institutional Review Board. The intended pool of volunteers will be from residents, attendings, and medical students in the hospital. The consent form will clearly specify that their participation in the study will not impact their academic status or employment.

The subjects randomized to the Albuterol arm will receive a one hour 10 mg continuous Albuterol nebulizer treatment. Those randomized to placebo will receive a one-hour saline nebulizer treatment. The chief pharmacist for the study will randomly assign a number between one and thirty to fifteen Albuterol treatments and fifteen placebo treatments.

Subjects will be monitored with cardiac monitor and serum lactate levels will be drawn every 15 minutes.
Study Started
Apr 30
Primary Completion
Jul 31
Study Completion
Aug 31
Results Posted
Aug 14
Last Update
Aug 14

Drug Normal Saline

One hour inhaled normal saline

  • Other names: NS, Saline

Drug Albuterol

One hour inhaled ten milligrams of albuterol

  • Other names: Ventilin, Proventil

Normal Saline Control Group Placebo Comparator

Control group will be administered a one hour normal saline inhaled treatment.

Albuterol Trial Group Active Comparator

Trial group to be administered one hour treatment of ten milligrams of inhaled albuterol


Inclusion Criteria:

18 years or older

Exclusion Criteria:

beta agonist allergy
taking furosemide, insulin, thiazide diuretics, metformin or acetazolamide
coronary artery disease
abnormal heart rhythm
baseline serum lactate level >2.2 mmol/L
baseline heart rate > 120



Normal Saline

All Events

Event Type Organ System Event Term

Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment.

We powered our study to detect a difference of 0.5 mmol/L between pre and post-treatment lactate levels, but hypothesize that the difference will be greater than 1.0 mmol/L.

Normal Saline Control Group

mmol/L (Mean)
95% Confidence Interval: -0.39 to 0.09

Albuterol Trial Group

mmol/L (Mean)
95% Confidence Interval: 0.52 to 1.02



Age, Continuous

years (Median)
Inter-Quartile Range: 26.0 to 32.3

Region of Enrollment

Sex: Female, Male

Overall Study

Normal Saline Control Group

Albuterol Trial Group