Continuous Levalbuterol for Treatment of Status Asthmaticus in Children

This study has been completed.
Sponsor:
Collaborator:
Sunovion
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00124176
First received: July 25, 2005
Last updated: February 12, 2013
Last verified: December 2012
Results First Received: July 14, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Racemic albuterol (R+S albuterol)
Drug: Levalbuterol (R albuterol)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Continuous Levalbuterol (R) Nebulized Solution Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
Continuous Racemic (R+S) Albuterol Continuous racemic albuterol 20mg/hr given as continuous nebulization

Participant Flow:   Overall Study
    Continuous Levalbuterol (R) Nebulized Solution     Continuous Racemic (R+S) Albuterol  
STARTED     40     41  
Received Study Drug     37 [1]   41  
COMPLETED     40     41  
NOT COMPLETED     0     0  
[1] 3 never started on drug due to improvement but were kept in the study by intention to treat.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Continuous Levalbuterol (R) Nebulized Solution Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
Continuous Racemic (R+S) Albuterol Continuous racemic albuterol 20mg/hr given as continuous nebulization
Total Total of all reporting groups

Baseline Measures
    Continuous Levalbuterol (R) Nebulized Solution     Continuous Racemic (R+S) Albuterol     Total  
Number of Participants  
[units: participants]
  40     41     81  
Age  
[units: participants]
     
<=18 years     40     41     81  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  10.4  ± 3.5     10.7  ± 3.3     10.6  ± 3.4  
Gender  
[units: participants]
     
Female     14     16     30  
Male     26     25     51  
Region of Enrollment  
[units: participants]
     
United States     40     41     81  



  Outcome Measures
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1.  Primary:   Duration of Continuous Therapy   [ Time Frame: During hospitalization ]

2.  Secondary:   Change in Pediatric Asthma Severity Score   [ Time Frame: After 12 hours of continuous nebulization ]

3.  Secondary:   Heart Rate   [ Time Frame: After 12 hours of continuous nebulization ]

4.  Secondary:   Serum Potassium Levels   [ Time Frame: After 12 hours of continuous nebulization ]

5.  Secondary:   Serum Albuterol S Isomer Levels   [ Time Frame: After 6 hours of continuous albuterol ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Joseph Zorc, MD
Organization: Children's Hospital of Philadelphia
phone: 215-590-1944
e-mail: zorc@email.chop.edu


No publications provided


Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00124176     History of Changes
Other Study ID Numbers: #2004-12-4130
Study First Received: July 25, 2005
Results First Received: July 14, 2010
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board