Trial Outcomes & Findings for Inhaled Corticosteroids After a Pediatric Emergency Visit for Asthma (NCT NCT00294398)

Results Overview

Verification of a filled prescription for an ICS was completed 2 months after emergency department (ED) visit via telephone call to the pharmacy. Individual informed consent forms were faxed to the pharmacy to obtain verification that a prescription was filled. The number of subjects who filled a prescription for an ICS after the ED visit was compared between the two groups.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

152 participants

Primary outcome timeframe

2 months

Results posted on

2015-05-13

Participant Flow

Patients were screened for enrollment at the Children's Hospital of Philadelphia Emergency Department (ED) between 2006 to 2009. Of the 75,000 annual ED visits in the Children's Hospital of Philadelphia ED per year, more than 6,000 of these visit represent patients with acute asthma.

152 participants were enrolled and randomized between 2006 and 2009 in the Children's Hospital of Philadelphia Emergency Department.

Participant milestones

Participant milestones
Measure	Standard Asthma ED Discharge Therapy Subjects were instructed to use albuterol as needed (up to every 4 hours), may have been prescribed prednisone and asked to follow-up with their primary doctor in 3-5 days. All viewed an educational video about asthma control and were provided a home nebulizer if needed.	ICS Prescription + Standard Asthma ED Discharge Therapy Subjects were given a prescription for a 30 day supply of an inhaled corticosteroid based on age: 1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily
Overall Study STARTED	78	74
Overall Study COMPLETED	57	48
Overall Study NOT COMPLETED	21	26

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Asthma ED Discharge Therapy Subjects were instructed to use albuterol as needed (up to every 4 hours), may have been prescribed prednisone and asked to follow-up with their primary doctor in 3-5 days. All viewed an educational video about asthma control and were provided a home nebulizer if needed.	ICS Prescription + Standard Asthma ED Discharge Therapy Subjects were given a prescription for a 30 day supply of an inhaled corticosteroid based on age: 1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily
Overall Study Lost to Follow-up	21	26

Baseline Characteristics

Inhaled Corticosteroids After a Pediatric Emergency Visit for Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Asthma ED Discharge Therapy n=78 Participants Subjects were instructed to use albuterol as needed (up to every 4 hours), may have been prescribed prednisone and asked to follow-up with their primary doctor in 3-5 days. All viewed an educational video about asthma control and are provided a home nebulizer if needed.	ICS Prescription + Standard ED Discharge Therapy n=74 Participants Subjects were given a prescription for a 30 day supply of an inhaled corticosteroid based on age: 1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily	Total n=152 Participants Total of all reporting groups
Age, Categorical <=18 years	78 Participants n=5 Participants	74 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	4.5 years STANDARD_DEVIATION 3.1 • n=5 Participants	5.5 years STANDARD_DEVIATION 4.8 • n=7 Participants	5.0 years STANDARD_DEVIATION 4.0 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	36 Participants n=7 Participants	66 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	38 Participants n=7 Participants	86 Participants n=5 Participants
Region of Enrollment United States	78 participants n=5 Participants	74 participants n=7 Participants	152 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Population: Analysis population was based on the intention to treat number at enrollment.

Verification of a filled prescription for an ICS was completed 2 months after emergency department (ED) visit via telephone call to the pharmacy. Individual informed consent forms were faxed to the pharmacy to obtain verification that a prescription was filled. The number of subjects who filled a prescription for an ICS after the ED visit was compared between the two groups.

Outcome measures

Outcome measures
Measure	Standard Asthma ED Discharge Therapy n=78 Participants Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.	ICS Prescription + Standard Asthma ED Discharge Therapy: n=74 Participants Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age: 1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily
Number of Inhaled Corticosteroid (ICS) Prescriptions Refilled (Confirmed by Primary Care Physician)	18 Participants	32 Participants

SECONDARY outcome

Timeframe: 2 months

Population: Analysis population was based on the intention to treat number at enrollment.

Bukstein health-related quality of life instrument is an an 8-item questionnaire for measuring health-related quality of life in pediatric asthma. The daytime and nighttime symptom scales for each contain 2 items and the functional limitations scale 4 items. Prior validation studies confirm each scale's ability to detect changes at both low and high levels of functioning. The scale is scored from 0 to 100, with higher scores indicating better quality of life and lower scores translate to poorer health-related quality of life.

Outcome measures

Outcome measures
Measure	Standard Asthma ED Discharge Therapy n=36 Participants Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.	ICS Prescription + Standard Asthma ED Discharge Therapy: n=30 Participants Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age: 1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily
Asthma-related Quality of Life	65 units on a scale Standard Deviation 21	66 units on a scale Standard Deviation 27

Adverse Events

Standard Asthma ED Discharge Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ICS Prescription + Standard Asthma ED Discharge Therapy

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

Esther Sampayo MD MPH

CHOP

Phone: 215-590-1944

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place