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

This study has been completed.

Study NCT00585039 Information provided by Phoenix Children's Hospital

First Received on December 20, 2007. Last Updated on September 2, 2011 History of Changes

Results First Received: March 17, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Asthma
Intervention:	Drug: xopenex

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Children 6 to 17 years who presented to ED with asthma exacerbation of moderate to severe nature.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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

Participant Flow: Overall Study

	Levalbuterol (Xopenex)	Albuterol
STARTED	57	44
COMPLETED	55	44
NOT COMPLETED	2	0
medication spilled	2	0

Baseline Characteristics

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Reporting Groups

	Description
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

Baseline Measures

	Levalbuterol (Xopenex)	Albuterol	Total
Number of Participants [units: participants]	57	44	101
Age [units: participants]
<=18 years	57	44	101
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Gender [units: participants]
Female	39	33	72
Male	18	11	29
Region of Enrollment [units: participants]
United States	57	44	101

Outcome Measures

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1. Primary:

Change in Forced Expiratory Volume in 1 Sec (FEV1) Measured in L/Sec [ Time Frame: Baseline and 4 hours ]

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2. Secondary:

Clinical Asthma Score (CAS) [ Time Frame: 4 hours ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Dr Blake Bulloch
Organization: Phoenix Children's Hospital
phone: 602-546-1950
e-mail: bbulloch@phoenixchildrens.com

No publications provided

Responsible Party:	Robert Bulloch, MD, Phoenix Children's Hospital
ClinicalTrials.gov Identifier:	NCT00585039 History of Changes
Other Study ID Numbers:	SRC176
Study First Received:	December 20, 2007
Results First Received:	March 17, 2011
Last Updated:	September 2, 2011
Health Authority:	United States: Institutional Review Board