Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 857 for:    ALBUTEROL

The Various Effects of Gaseous Albuterol on Serum Lactate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02073747
Recruitment Status : Completed
First Posted : February 27, 2014
Results First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Joseph Anthony Zitek, University Medical Center of Southern Nevada

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Health Services Research
Condition Asthma
Interventions Drug: Normal Saline
Drug: Albuterol
Enrollment 28
Recruitment Details Healthy volunteers were recruited from the investigators’ friends and family.
Pre-assignment Details  
Arm/Group Title Normal Saline Control Group Albuterol Trial Group
Hide Arm/Group Description

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

Normal Saline: One hour inhaled normal saline

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

Albuterol: One hour inhaled ten milligrams of albuterol

Period Title: Overall Study
Started 15 15
Completed 14 14
Not Completed 1 1
Arm/Group Title Albuterol Normal Saline Total
Hide Arm/Group Description Study group Control group Total of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
29
(24.5 to 30)
28
(26.3 to 34.5)
28.5
(26 to 32.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
4
  28.6%
7
  50.0%
11
  39.3%
Male
10
  71.4%
7
  50.0%
17
  60.7%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 14 participants 14 participants 28 participants
14
 100.0%
14
 100.0%
28
 100.0%
1.Primary Outcome
Title Number of Subjects With a Change From Baseline Serum Lactate Following a One Hour Albuterol Nebulizer Treatment.
Hide Description 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.
Time Frame Change in serum lactate from baseline to 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Normal Saline Control Group Albuterol Trial Group
Hide Arm/Group Description:

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

Normal Saline: One hour inhaled normal saline

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

Albuterol: One hour inhaled ten milligrams of albuterol

Overall Number of Participants Analyzed 14 14
Mean (95% Confidence Interval)
Unit of Measure: mmol/L
-0.15
(-0.39 to 0.09)
0.77
(0.52 to 1.02)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Albuterol Normal Saline
Hide Arm/Group Description Study group; 10 mg of nebulizer albuterol Control group
All-Cause Mortality
Albuterol Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Albuterol Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Albuterol Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Emergency Department Research Coordinator
Organization: University Medical Center of Southern Nevada
Phone: 702-224-7124
EMail: wesley.forred@umcsn.com
Layout table for additonal information
Responsible Party: Joseph Anthony Zitek, University Medical Center of Southern Nevada
ClinicalTrials.gov Identifier: NCT02073747     History of Changes
Other Study ID Numbers: EM 2014.01
First Submitted: February 19, 2014
First Posted: February 27, 2014
Results First Submitted: June 10, 2017
Results First Posted: August 14, 2017
Last Update Posted: August 14, 2017