Heliox-Powered Albuterol Therapy in the Treatment of Children Admitted With Acute Asthma Exacerbation

This study has been terminated.
(Study was stopped after interim analysis and slow enrollment.)
Sponsor:
Information provided by:
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT00410150
First received: December 11, 2006
Last updated: October 22, 2010
Last verified: October 2010
Results First Received: September 15, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Status Asthmaticus
Interventions: Drug: Helium-oxygen-driven albuterol nebulizer
Drug: Oxygen

  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
No text entered.

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
Heliox Group Patients randomized to the Heliox arm of the study
Control Group Subjects randomized to the control arm of the study

Participant Flow:   Overall Study
    Heliox Group     Control Group  
STARTED     22     20  
COMPLETED     20 [1]   17 [2]
NOT COMPLETED     2     3  
[1] 2 study withdrawals (analyzed by intention-to-treat)
[2] 3 study withdrawals (analyzed by intention-to-treat0



  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.
No text entered.

Reporting Groups
  Description
Heliox Group Patients randomized to the Heliox arm of the study
Control Group Subjects randomized to the control arm of the study
Total Total of all reporting groups

Baseline Measures
    Heliox Group     Control Group     Total  
Number of Participants  
[units: participants]
  22     20     42  
Age  
[units: participants]
     
<=18 years     22     20     42  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  7.3  ± 0.8     8.2  ± 0.9     7.8  ± 0.8  
Gender  
[units: participants]
     
Female     9     6     15  
Male     13     14     27  
Region of Enrollment  
[units: participants]
     
United States     22     20     42  



  Outcome Measures

1.  Primary:   Length of Stay   [ Time Frame: Hospital discharge ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Derek Wheeler
Organization: Cincinnati Children's Hospital Medical Center
phone: 513-636-4239
e-mail: derek.wheeler@cchmc.org


Publications:


Responsible Party: Derek Wheeler, Cincinnati Children's Hospital Medical Center
ClinicalTrials.gov Identifier: NCT00410150     History of Changes
Other Study ID Numbers: 05-11-34-74-067
Study First Received: December 11, 2006
Results First Received: September 15, 2010
Last Updated: October 22, 2010
Health Authority: United States: Food and Drug Administration