Trial Outcomes & Findings for Oral Prednisolone Dosing in Children Hospitalized With Asthma (NCT NCT00257933)

NCT ID: NCT00257933

Last Updated: 2010-12-31

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 152 participants
• Primary outcome timeframe: Median time from loading dose to home dose of albuterol
• Results posted on: 2010-12-31

Participant Flow

Participant milestones

Measure	High Dose Prednisolone High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours	Lower Dose Prednisolone Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
Overall Study STARTED	74	78
Overall Study COMPLETED	74	78
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Prednisolone Dosing in Children Hospitalized With Asthma

Baseline characteristics by cohort

Measure	High Dose Prednisolone n=74 Participants High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours	Lower Dose Prednisolone n=78 Participants Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo	Total n=152 Participants Total of all reporting groups
Age, Categorical <=18 years	74 Participants n=5 Participants	78 Participants n=7 Participants	152 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	7.9 years STANDARD_DEVIATION 4.4 • n=5 Participants	7.0 years STANDARD_DEVIATION 3.8 • n=7 Participants	7.4 years STANDARD_DEVIATION 4.2 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	27 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	51 Participants n=7 Participants	98 Participants n=5 Participants
Region of Enrollment United States	74 participants n=5 Participants	78 participants n=7 Participants	152 participants n=5 Participants

PRIMARY outcome

Timeframe: Median time from loading dose to home dose of albuterol

Outcome measures

Measure	High Dose Prednisolone n=74 Participants High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours	Lower Dose Prednisolone n=78 Participants Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
Time Measured From the Administration of the Loading Dose of Prednisolone (2mg/kg up to Max 60mg) in the Emergency Department (ED) Until the Home Dose of Albuterol is Administered	35 Hours Interval 26.0 to 71.0	33 Hours Interval 25.0 to 51.0

SECONDARY outcome

Timeframe: Mean time from writing admit order until discharge order

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time spent in each severity level of pathway

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 4 hours during hospitalization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every 4 hours during hospitalization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 weeks after hospitalization

Outcome measures

Outcome data not reported

Adverse Events

High Dose Prednisolone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lower Dose Prednisolone

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

Joseph Zorc, MD

The Children's Hospital of Philadelphia

Phone: 215-590-1944

Email: zorc@email.chop.edu

Results disclosure agreements

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