Trial Outcomes & Findings for Heliox-Powered Albuterol Therapy in the Treatment of Children Admitted With Acute Asthma Exacerbation (NCT NCT00410150)

NCT ID: NCT00410150

Last Updated: 2010-11-08

Results Overview

Time to discharge eligibility (hours)

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 42 participants
• Primary outcome timeframe: Hospital discharge
• Results posted on: 2010-11-08

Participant Flow

Participant milestones

Measure	Heliox Group Patients randomized to the Heliox arm of the study	Control Group Subjects randomized to the control arm of the study
Overall Study STARTED	22	20
Overall Study COMPLETED	20	17
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Heliox Group n=22 Participants Patients randomized to the Heliox arm of the study	Control Group n=20 Participants Subjects randomized to the control arm of the study	Total n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	22 Participants n=5 Participants	20 Participants n=7 Participants	42 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	7.3 years STANDARD_DEVIATION 0.8 • n=5 Participants	8.2 years STANDARD_DEVIATION 0.9 • n=7 Participants	7.8 years STANDARD_DEVIATION 0.8 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	20 participants n=7 Participants	42 participants n=5 Participants

PRIMARY outcome

Timeframe: Hospital discharge

Time to discharge eligibility (hours)

Outcome measures

Measure	Heliox Group n=22 Participants Patients randomized to the Heliox arm of the study	Control Group n=20 Participants Subjects randomized to the control arm of the study
Length of Stay	66.2 hours Standard Error 8.7	63.4 hours Standard Error 8.6

Adverse Events

Heliox Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Derek Wheeler

Cincinnati Children's Hospital Medical Center

Phone: 513-636-4239

Email: derek.wheeler@cchmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place