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Trial record 13 of 36 for:    "Status Asthmaticus"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00410150
Recruitment Status : Terminated (Study was stopped after interim analysis and slow enrollment.)
First Posted : December 12, 2006
Results First Posted : October 13, 2010
Last Update Posted : November 8, 2010
Sponsor:
Information provided by:
Children's Hospital Medical Center, Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Status Asthmaticus
Interventions Drug: Helium-oxygen-driven albuterol nebulizer
Drug: Oxygen
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Heliox Group Control Group
Hide Arm/Group Description Patients randomized to the Heliox arm of the study Subjects randomized to the control arm of the study
Period Title: Overall Study
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
Arm/Group Title Heliox Group Control Group Total
Hide Arm/Group Description Patients randomized to the Heliox arm of the study Subjects randomized to the control arm of the study Total of all reporting groups
Overall Number of Baseline Participants 22 20 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 42 participants
<=18 years
22
 100.0%
20
 100.0%
42
 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%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 20 participants 42 participants
7.3  (0.8) 8.2  (0.9) 7.8  (0.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 42 participants
Female
9
  40.9%
6
  30.0%
15
  35.7%
Male
13
  59.1%
14
  70.0%
27
  64.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 20 participants 42 participants
22 20 42
1.Primary Outcome
Title Length of Stay
Hide Description Time to discharge eligibility (hours)
Time Frame Hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Heliox Group Control Group
Hide Arm/Group Description:
Patients randomized to the Heliox arm of the study
Subjects randomized to the control arm of the study
Overall Number of Participants Analyzed 22 20
Mean (Standard Error)
Unit of Measure: hours
66.2  (8.7) 63.4  (8.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Heliox Group Control Group
Hide Arm/Group Description Patients randomized to the Heliox arm of the study Subjects randomized to the control arm of the study
All-Cause Mortality
Heliox Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Heliox Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Heliox Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/20 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Derek Wheeler
Organization: Cincinnati Children's Hospital Medical Center
Phone: 513-636-4239
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
First Submitted: December 11, 2006
First Posted: December 12, 2006
Results First Submitted: September 15, 2010
Results First Posted: October 13, 2010
Last Update Posted: November 8, 2010