Trial Outcomes & Findings for Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults (NCT NCT02802111)
NCT ID: NCT02802111
Last Updated: 2020-10-28
Results Overview
Oxygen consumption will be measured following for up to 60 minutes beta agonist aerosol
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
0 to 60 minutes
Results posted on
2020-10-28
Participant Flow
Participant milestones
| Measure |
Albuterol 5 mg First, Then Levalbuterol 2.5 mg
Patient receives albuterol 5 mg aerosolized first and then 4 hours or greater after receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
Albuterol: Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
|
Levalbuterol 2.5 mg First, Then Albuterol 5 mg
Patient receives levalbuterol 2.5 mg aerosolized first and then 4 hours or greater after receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
Levalbuterol: Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention
|
|---|---|---|
|
First Intervention (5 Min of Drug)
STARTED
|
12
|
12
|
|
First Intervention (5 Min of Drug)
COMPLETED
|
12
|
12
|
|
First Intervention (5 Min of Drug)
NOT COMPLETED
|
0
|
0
|
|
Washout (4 Hours)
STARTED
|
12
|
12
|
|
Washout (4 Hours)
COMPLETED
|
12
|
12
|
|
Washout (4 Hours)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (5 Min of Drug)
STARTED
|
12
|
12
|
|
Second Intervention (5 Min of Drug)
COMPLETED
|
12
|
12
|
|
Second Intervention (5 Min of Drug)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults
Baseline characteristics by cohort
| Measure |
Albuterol 5 mg First, Then Levalbuterol 2.5 mg
n=12 Participants
Patient receives albuterol 5 mg aerosolized first and then 4 hours or greater after receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
Albuterol: Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
|
Levalbuterol 2.5 mg First, Then Albuterol 5 mg
n=12 Participants
Patient receives levalbuterol 2.5 mg aerosolized first and then 4 hours or greater after receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
Levalbuterol: Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30 years
n=5 Participants
|
34 years
n=7 Participants
|
32 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 60 minutesPopulation: Healthy volunteers, median age 32 years. The population is 24 individuals they are randomized to which bronchodilator they received first. Half were randomized to Albuterol and half to levalbuterol but each subject received both medication. It is a matter of which they received first. There was a four hour wash out period between the first and second medication.
Oxygen consumption will be measured following for up to 60 minutes beta agonist aerosol
Outcome measures
| Measure |
Albuterol 5 mg First, Then Levalbuterol 2.5 mg
n=24 Participants
Patient receives albuterol 5 mg aerosolized first and then 4 hours or greater after receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
Albuterol: Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
|
Levalbuterol 2.5 mg First, Then Albuterol 5 mg
n=24 Participants
Patient receives levalbuterol 2.5 mg aerosolized first and then 4 hours or greater after receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
Levalbuterol: Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention
|
|---|---|---|
|
Oxygen Consumption
|
.28 mls/kg/min
Interval 0.15 to 0.36
|
.27 mls/kg/min
Interval 0.19 to 0.35
|
SECONDARY outcome
Timeframe: 0 to 60 minutesPopulation: Healthy volunteers, median age 32 years. The population is 24 individuals they are randomized to which bronchodilator they received first. Half were randomized to Albuterol and half to levalbuterol but each subject received both medication. It is a matter of which they received first. There was a four hour wash out period between the first and second medication.
Vital signs including heart rate will be measured for up to 60 minutes following beta agonist
Outcome measures
| Measure |
Albuterol 5 mg First, Then Levalbuterol 2.5 mg
n=24 Participants
Patient receives albuterol 5 mg aerosolized first and then 4 hours or greater after receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
Albuterol: Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
|
Levalbuterol 2.5 mg First, Then Albuterol 5 mg
n=24 Participants
Patient receives levalbuterol 2.5 mg aerosolized first and then 4 hours or greater after receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
Levalbuterol: Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention
|
|---|---|---|
|
Heart Rate
|
91 beats per minute
Interval 84.0 to 103.0
|
93 beats per minute
Interval 87.0 to 102.0
|
Adverse Events
Albuterol 5 mg First, Then Levalbuterol 2.5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Levalbuterol 2.5 mg First, Then Albuterol 5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place