Trial Outcomes & Findings for A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation (NCT NCT00583778)
NCT ID: NCT00583778
Last Updated: 2022-05-16
Results Overview
Measure FEV-1 in participants immediately prior to treatment and 60 minutes after final treatment to determine improvement in bronchodilation after 1.25mg nebulized levalbuterol + 0.5mg nebulized ipratropium administered every 20 minutes for a total of 3 doses versus bronchodilation after 1.25mg nebulized levalbuterol administered every 20 minutes for a total of 3 doses. FEV-1 measurements were obtained using a hand held spirometer. A difference in 12% of median FEV-1 measures between the two groups was considered clinically significant. Patients were called 14 days after their ED visit to assess relapse or recurrence of acute asthma exacerbation. In addition, a chart review was performed to assess relapse or recurrence of acute asthma exacerbation, as well as determine hospital length of stay in those patients who required admission after the initial visit.
COMPLETED
NA
141 participants
FEV-1 measured Immediately before treatment dose 1 & 60 minutes after completion of treatment dose 3. Assessment of relapse or recurrence were determined at day 14 after the ED visit.
2022-05-16
Participant Flow
Adult patients between the ages if 18 and 45 years presenting to the emergency department with acute asthma. They were enrolled by one of the study nurses. Patients were eligible to enroll if their FEV-1 was less than 50% predicted on arrival. Enrollment occurred between December 2005 and December 2008.
Participant milestones
| Measure |
Levalbuterol
levalbuterol 1.25 mg every 20 minutes for 3 doses plus placebo (saline)
ipratropium: 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses
|
Levalbuterol Plus Ipratropium
ipratropium 0.5 mg nebulized every 20 minutes for 3 doses added to levalbuterol 1.25 mg every 20 minutes for 3 doses
ipratropium: 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
67
|
|
Overall Study
COMPLETED
|
74
|
67
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Levalbuterol Plus Ipratropium With Levalbuterol Alone in the Treatment of Acute Asthma Exacerbation
Baseline characteristics by cohort
| Measure |
Levalbuterol
n=74 Participants
levalbuterol 1.25 mg every 20 minutes for 3 doses plus placebo (saline)
ipratropium: 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses
|
Levalbuterol Plus Ipratropium
n=67 Participants
ipratropium 0.5 mg nebulized every 20 minutes for 3 doses added to levalbuterol 1.25 mg every 20 minutes for 3 doses
ipratropium: 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
74 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
31.1 years
n=99 Participants
|
30.3 years
n=107 Participants
|
30.6 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
74 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
141 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: FEV-1 measured Immediately before treatment dose 1 & 60 minutes after completion of treatment dose 3. Assessment of relapse or recurrence were determined at day 14 after the ED visit.Measure FEV-1 in participants immediately prior to treatment and 60 minutes after final treatment to determine improvement in bronchodilation after 1.25mg nebulized levalbuterol + 0.5mg nebulized ipratropium administered every 20 minutes for a total of 3 doses versus bronchodilation after 1.25mg nebulized levalbuterol administered every 20 minutes for a total of 3 doses. FEV-1 measurements were obtained using a hand held spirometer. A difference in 12% of median FEV-1 measures between the two groups was considered clinically significant. Patients were called 14 days after their ED visit to assess relapse or recurrence of acute asthma exacerbation. In addition, a chart review was performed to assess relapse or recurrence of acute asthma exacerbation, as well as determine hospital length of stay in those patients who required admission after the initial visit.
Outcome measures
| Measure |
Levalbuterol
n=141 Participants
levalbuterol 1.25 mg every 20 minutes for 3 doses plus placebo (saline)
|
Levalbuterol Plus Ipratropium
n=141 Participants
ipratropium 0.5 mg nebulized every 20 minutes for 3 doses added to levalbuterol 1.25 mg every 20 minutes for 3 doses
ipratropium: 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses
|
|---|---|---|
|
Number of Participants With Bronchodilation
|
74 Participants
|
67 Participants
|
PRIMARY outcome
Timeframe: 60 minutesPopulation: Overall Number of Participants Analyzed 141
Primary Outcome- the difference in FEV-1at 60 minutes between participants who received Levalbuterol 1.25 mg x 3 vs participants who received Levalbuterol 1.25 mg x3 + Ipratropium 0.5 mg x3
Outcome measures
| Measure |
Levalbuterol
n=74 Participants
levalbuterol 1.25 mg every 20 minutes for 3 doses plus placebo (saline)
|
Levalbuterol Plus Ipratropium
n=67 Participants
ipratropium 0.5 mg nebulized every 20 minutes for 3 doses added to levalbuterol 1.25 mg every 20 minutes for 3 doses
ipratropium: 0.5 mg of ipratropium added to 1.25 mg levalbuterol given every 20 minutes for 3 doses
|
|---|---|---|
|
Change in FEV-1 % Predicted Over Time
|
45 percentage of FEV-1 predicted
Interval 37.0 to 58.0
|
47 percentage of FEV-1 predicted
Interval 40.0 to 63.0
|
Adverse Events
Levalbuterol
Levalbuterol Plus Ipratropium
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