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

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ClinicalTrials.gov Identifier: NCT00585039
Recruitment Status : Completed
First Posted : January 2, 2008
Results First Posted : August 16, 2011
Last Update Posted : September 9, 2011
Sponsor:
Information provided by:
Phoenix Children's Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Intervention Drug: xopenex
Enrollment 101
Recruitment Details Children 6 to 17 years who presented to ED with asthma exacerbation of moderate to severe nature.
Pre-assignment Details 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.
Arm/Group Title Levalbuterol (Xopenex) Albuterol
Hide Arm/Group Description Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
Period Title: Overall Study
Started 57 44
Completed 55 44
Not Completed 2 0
Reason Not Completed
medication spilled             2             0
Arm/Group Title Levalbuterol (Xopenex) Albuterol Total
Hide Arm/Group Description Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes Total of all reporting groups
Overall Number of Baseline Participants 57 44 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 44 participants 101 participants
<=18 years
57
 100.0%
44
 100.0%
101
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 44 participants 101 participants
Female
39
  68.4%
33
  75.0%
72
  71.3%
Male
18
  31.6%
11
  25.0%
29
  28.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 57 participants 44 participants 101 participants
57 44 101
1.Primary Outcome
Title Change in Forced Expiratory Volume in 1 Sec (FEV1) Measured in L/Sec
Hide Description [Not Specified]
Time Frame Baseline and 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Enrollment period ended prior to final goal sample size. ITT.
Arm/Group Title Levalbuterol (Xopenex) Albuterol
Hide Arm/Group Description:
Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
Overall Number of Participants Analyzed 55 44
Mean (95% Confidence Interval)
Unit of Measure: L/sec
19.8
(14.4 to 67)
55.2
(28 to 75.7)
2.Secondary Outcome
Title Clinical Asthma Score (CAS)
Hide Description 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).
Time Frame 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
analysis per protocol
Arm/Group Title Levalbuterol Albuterol
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 55 44
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.7
(0 to 2.9)
3.0
(1.2 to 3.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levalbuterol (Xopenex) Albuterol
Hide Arm/Group Description Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
All-Cause Mortality
Levalbuterol (Xopenex) Albuterol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Levalbuterol (Xopenex) Albuterol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)   0/44 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Levalbuterol (Xopenex) Albuterol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/55 (0.00%)   0/44 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr Blake Bulloch
Organization: Phoenix Children's Hospital
Phone: 602-546-1950
Responsible Party: Robert Bulloch, MD, Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT00585039     History of Changes
Other Study ID Numbers: SRC176
First Submitted: December 20, 2007
First Posted: January 2, 2008
Results First Submitted: March 17, 2011
Results First Posted: August 16, 2011
Last Update Posted: September 9, 2011