Trial Outcomes & Findings for Effect of Nebulized Bronchodilators on Heart Rate (NCT NCT01151579)
NCT ID: NCT01151579
Last Updated: 2015-10-23
Results Overview
Average difference in Heart rate between pre and post breathing treatments
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
89 participants
Primary outcome timeframe
Five days
Results posted on
2015-10-23
Participant Flow
Recruitment began initially August 21, 2007 at the medical center ICU.
Patients were excluded if they had a known allergy or sensitivity to study medications or if baseline heart rate was greater than 110 bpm. Treating physicians detremined the need for and frequency of treatment with bronchodilator therapy. All other medications were allowed.
Participant milestones
| Measure |
Nebulized Albuterol 2.5mg
Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
|
Levalbuterol 1.25
Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
31
|
|
Overall Study
COMPLETED
|
46
|
24
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
Reasons for withdrawal
| Measure |
Nebulized Albuterol 2.5mg
Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
|
Levalbuterol 1.25
Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Not meet inclusion criteria
|
6
|
4
|
Baseline Characteristics
Effect of Nebulized Bronchodilators on Heart Rate
Baseline characteristics by cohort
| Measure |
Nebulized Albuterol 2.5mg
n=58 Participants
Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
|
Levalbuterol 1.25
n=31 Participants
Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
27 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
40 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
62 Participants
n=35 Participants
|
|
Age, Continuous
|
67.3 years
STANDARD_DEVIATION 13.1 • n=39 Participants
|
67.5 years
STANDARD_DEVIATION 13.7 • n=41 Participants
|
67.3 years
STANDARD_DEVIATION 13.4 • n=35 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
43 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
46 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=39 Participants
|
31 participants
n=41 Participants
|
89 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Five daysPopulation: Average change in heart rate from baseline to final breathing treatment.
Average difference in Heart rate between pre and post breathing treatments
Outcome measures
| Measure |
Nebulized Albuterol 2.5mg
n=604 Breathing treatment episodes
Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
|
Levalbuterol 1.25
n=232 Breathing treatment episodes
Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
|
|---|---|---|
|
Heart Rate in Beats Per Minute
|
-0.16 bpm
Standard Deviation 5.1
|
1.40 bpm
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: 15 minutes after each treatment for average of 3 to 5 daysPopulation: The percentage of arrhythmias among the number of breathing treatments.
Any new arrhythmia documented in the medical record that occurred between breathing treatments.
Outcome measures
| Measure |
Nebulized Albuterol 2.5mg
n=46 Participants
Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
|
Levalbuterol 1.25
n=24 Participants
Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
|
|---|---|---|
|
Arrhythmias
|
0.33 percent
|
1.3 percent
|
SECONDARY outcome
Timeframe: Five daysPopulation: Number of patients for whom arrhythmias occurred within 5 days after treatment initiation.
Documented new arrhythmia occurring during study.
Outcome measures
| Measure |
Nebulized Albuterol 2.5mg
n=46 Participants
Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
|
Levalbuterol 1.25
n=24 Participants
Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
|
|---|---|---|
|
Total Number of Participants With Arrhythmias
|
2 participants
|
3 participants
|
Adverse Events
Nebulized Albuterol 2.5mg
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Levalbuterol 1.25
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nebulized Albuterol 2.5mg
n=58 participants at risk
Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
|
Levalbuterol 1.25
n=31 participants at risk
Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
|
|---|---|---|
|
Cardiac disorders
Ventricular tachycardia
|
3.4%
2/58 • Number of events 2 • Within 5 days of treatment initiation and within 15 minutes of each individual treatment.
Cardiac arrhythmia
|
9.7%
3/31 • Number of events 3 • Within 5 days of treatment initiation and within 15 minutes of each individual treatment.
Cardiac arrhythmia
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place