Trial Outcomes & Findings for Inhaled Steroids at Discharge After Emergency Department Visits for Children With Uncontrolled Asthma (NCT NCT01881412)
NCT ID: NCT01881412
Last Updated: 2020-05-18
Results Overview
The Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) has been validated in the ED setting for children 2 to 17 years old, is reliable (Cronbach's α =0.70), and can be administered by telephone. Each item is rated on a 5-point scale. Each response is scaled as a percentage of the maximum response, and the total score is the maximum percentage based on the number of questions answered. The scores range from 0 (minimum) - 100 (maximum), with higher scores reflecting better quality of life. The change in ITG-CASF scores for children with improved overall clinical status are 10 points higher than when children have not improved.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
6 months
Results posted on
2020-05-18
Participant Flow
Participant milestones
| Measure |
Inhaled Corticosteroid (ICS)
Child receives: 1) asthma discharge instructions, and 2) ICS prescription.
Asthma Discharge Instructions include 1) describing asthma symptoms, 2) signs of respiratory distress, 3) instructions to visit the primary care provider within a week, 4) provision/review of asthma action plan, 5) providing an aerochamber device (if necessary) and 6) smoking cessation advice if indicated.
The family is also told that the child has been randomized to be prescribed an ICS to help control the asthma. Prescribing follows the NHLBI asthma guidelines for low dose ICS in this age group with 3 refills provided. In addition to standard asthma discharge instructions, the family receives specific instructions for ICS administration, possible side effects of ICS use, and teaching about controller and quick-relief rescue medications. Parents are instructed to discuss with their primary care provider the length of ICS use.
|
Routine Asthma Care
Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)
Asthma Discharge Instructions include 1) describing asthma symptoms, 2) signs of respiratory distress, 3) instructions to visit the primary care provider within a week, 4) provision/review of asthma action plan, 5) providing an aerochamber device (if necessary) and 6) smoking cessation advice if indicated.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
59
|
|
Overall Study
COMPLETED
|
49
|
57
|
|
Overall Study
NOT COMPLETED
|
10
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inhaled Steroids at Discharge After Emergency Department Visits for Children With Uncontrolled Asthma
Baseline characteristics by cohort
| Measure |
Inhaled Corticosteroid (ICS)
n=59 Participants
Child receives: 1) asthma discharge instructions, and 2) ICS prescription.
Asthma Discharge Instructions include 1) describing asthma symptoms, 2) signs of respiratory distress, 3) instructions to visit the primary care provider within a week, 4) provision/review of asthma action plan, 5) providing an aerochamber device (if necessary) and 6) smoking cessation advice if indicated.
The family is also told that the child has been randomized to be prescribed an ICS to help control the asthma. Prescribing follows the NHLBI asthma guidelines for low dose ICS in this age group with 3 refills provided. In addition to standard asthma discharge instructions, the family receives specific instructions for ICS administration, possible side effects of ICS use, and teaching about controller and quick-relief rescue medications. Parents are instructed to discuss with their primary care provider the length of ICS use.
|
Routine Asthma Care
n=59 Participants
Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)
Asthma Discharge Instructions include 1) describing asthma symptoms, 2) signs of respiratory distress, 3) instructions to visit the primary care provider within a week, 4) provision/review of asthma action plan, 5) providing an aerochamber device (if necessary) and 6) smoking cessation advice if indicated.
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.1 years
STANDARD_DEVIATION 2.4 • n=99 Participants
|
6.4 years
STANDARD_DEVIATION 2.3 • n=107 Participants
|
6.3 years
STANDARD_DEVIATION 2.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
20 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mixed race / other
|
8 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsThe Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF) has been validated in the ED setting for children 2 to 17 years old, is reliable (Cronbach's α =0.70), and can be administered by telephone. Each item is rated on a 5-point scale. Each response is scaled as a percentage of the maximum response, and the total score is the maximum percentage based on the number of questions answered. The scores range from 0 (minimum) - 100 (maximum), with higher scores reflecting better quality of life. The change in ITG-CASF scores for children with improved overall clinical status are 10 points higher than when children have not improved.
Outcome measures
| Measure |
Inhaled Corticosteroid (Fluticasone)
n=59 Participants
Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.
fluticasone: The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills).
Standard Asthma Discharge Instructions: 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)
|
Routine Asthma Care
n=59 Participants
Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)
Standard Asthma Discharge Instructions: Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)
|
|---|---|---|
|
Quality-of-life Using the Integrated Therapeutics Group Child Asthma Short Form
|
90 score on a scale
Standard Deviation 14
|
84 score on a scale
Standard Deviation 16
|
SECONDARY outcome
Timeframe: 6 monthsEmergency department visits for asthma over a 6 month period by parent report.
Outcome measures
| Measure |
Inhaled Corticosteroid (Fluticasone)
n=59 Participants
Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.
fluticasone: The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills).
Standard Asthma Discharge Instructions: 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)
|
Routine Asthma Care
n=59 Participants
Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)
Standard Asthma Discharge Instructions: Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)
|
|---|---|---|
|
ED Visits for Asthma
|
.37 visits
Standard Deviation 1
|
0.56 visits
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 6 monthsPrimary care visits well checks over a 6 month period by parent report.
Outcome measures
| Measure |
Inhaled Corticosteroid (Fluticasone)
n=59 Participants
Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.
fluticasone: The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills).
Standard Asthma Discharge Instructions: 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)
|
Routine Asthma Care
n=59 Participants
Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)
Standard Asthma Discharge Instructions: Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)
|
|---|---|---|
|
Primary Care Visits for Well Checks
|
1 visits
Standard Deviation 1.1
|
0.6 visits
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 6 monthsHospitalizations for asthma over a 6 month period by parent report.
Outcome measures
| Measure |
Inhaled Corticosteroid (Fluticasone)
n=59 Participants
Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.
fluticasone: The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills).
Standard Asthma Discharge Instructions: 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)
|
Routine Asthma Care
n=59 Participants
Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)
Standard Asthma Discharge Instructions: Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)
|
|---|---|---|
|
Hospitalizations for Asthma
|
.06 Hospitalizations
Standard Deviation .32
|
.05 Hospitalizations
Standard Deviation .23
|
SECONDARY outcome
Timeframe: 6 monthsUnscheduled primary care visits for asthma over a 6 month period by parent report.
Outcome measures
| Measure |
Inhaled Corticosteroid (Fluticasone)
n=59 Participants
Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.
fluticasone: The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills).
Standard Asthma Discharge Instructions: 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)
|
Routine Asthma Care
n=59 Participants
Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)
Standard Asthma Discharge Instructions: Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)
|
|---|---|---|
|
Unscheduled Primary Care Visits
|
.8 visits
Standard Deviation 1
|
1.7 visits
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 6 monthsOral steroid courses over a 6 month period by parent report.
Outcome measures
| Measure |
Inhaled Corticosteroid (Fluticasone)
n=59 Participants
Child receives: 1) standardized asthma discharge instructions, and the intervention which is 2) inhaled corticosteroid prescription with accompanying instructions.
fluticasone: The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills).
Standard Asthma Discharge Instructions: 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)
|
Routine Asthma Care
n=59 Participants
Child receives: 1) Standard Asthma Discharge Instructions. No intervention in this arm (placebo controlled)
Standard Asthma Discharge Instructions: Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)
|
|---|---|---|
|
Oral Steroid Courses
|
.54 Courses
Standard Deviation .87
|
0.7 Courses
Standard Deviation 1.1
|
Adverse Events
Inhaled Corticosteroid (Fluticasone)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Routine Asthma Care
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. Aris Garro
Rhode Island Hospital and Brown University
Phone: 401-480-8682
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place