Trial Outcomes & Findings for Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED) (NCT NCT00585039)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

101 participants

Primary outcome timeframe

Baseline and 4 hours

Results posted on

2026-02-10

Participant Flow

Children 6 to 17 years who presented to ED with asthma exacerbation of moderate to severe nature.

2 children were excluded from levalbuterol group after enrollment, 1 because the study medication spilled and another because they had received the medication outside protocol timeline. All other enrolled patients completed study.

Participant milestones

Participant milestones
Measure	Levalbuterol (Xopenex) Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes	Albuterol patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
Overall Study STARTED	57	44
Overall Study COMPLETED	55	44
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Levalbuterol (Xopenex) Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes	Albuterol patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
Overall Study medication spilled	2	0

Baseline Characteristics

Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levalbuterol (Xopenex) n=57 Participants Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes	Albuterol n=44 Participants patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes	Total n=202 Participants Total of all reporting groups
Age, Categorical <=18 years	57 Participants n=57 Participants	44 Participants n=44 Participants	101 Participants n=101 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=57 Participants	0 Participants n=44 Participants	0 Participants n=101 Participants
Age, Categorical >=65 years	0 Participants n=57 Participants	0 Participants n=44 Participants	0 Participants n=101 Participants
Sex: Female, Male Female	39 Participants n=57 Participants	33 Participants n=44 Participants	72 Participants n=101 Participants
Sex: Female, Male Male	18 Participants n=57 Participants	11 Participants n=44 Participants	29 Participants n=101 Participants
Region of Enrollment United States	57 participants n=57 Participants	44 participants n=44 Participants	101 participants n=101 Participants

PRIMARY outcome

Timeframe: Baseline and 4 hours

Population: Enrollment period ended prior to final goal sample size. ITT.

Outcome measures

Outcome measures
Measure	Levalbuterol (Xopenex) n=55 Participants Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes	Albuterol n=44 Participants patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
Change in Forced Expiratory Volume in 1 Sec (FEV1) Measured in L/Sec	19.8 L/sec Interval 14.4 to 67.0	55.2 L/sec Interval 28.0 to 75.7

SECONDARY outcome

Timeframe: 4 hours

Population: analysis per protocol

Change in clinical asthma score while in ED. 15 point clinical asthma score. Score ranges from 5 (no to mild respiratory distress) to a maximum of 15 (severe respiratory distress).

Outcome measures

Outcome measures
Measure	Levalbuterol (Xopenex) n=55 Participants Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes	Albuterol n=44 Participants patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
Clinical Asthma Score (CAS)	1.7 units on a scale Interval 0.0 to 2.9	3.0 units on a scale Interval 1.2 to 3.9

Adverse Events

Levalbuterol (Xopenex)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Albuterol

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

Dr Blake Bulloch

Phoenix Children's Hospital

Phone: 602-546-1950

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place