N/A
N=152
Inhaled Corticosteroids After a Pediatric Emergency Visit for Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00294398 ↗Enrolled (actual)
152
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Number of Inhaled Corticosteroid (ICS) Prescriptions Refilled (Confirmed by Primary Care Physician) — 18; 32 Participants — p=0.87
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ICS Prescription + Standard Asthma ED Discharge Therapy (Other); Standard Asthma ED Discharge Therapy (Other)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Inhaled Corticosteroid (ICS) Prescriptions Refilled (Confirmed by Primary Care Physician) |
18; 32 | 0.87 |
| SECONDARY Asthma-related Quality of Life |
65; 66 | — |
Summary
Specific Aim:
To determine whether a prescription for Inhaled Corticosteroids (ICS) added to standard Emergency Department (ED) discharge therapy for young children with persistent asthma symptoms increases ICS use and improves symptoms and quality of life over the months following the ED visit.
Hypotheses:
In a cohort of pediatric patients with persistent asthma discharged from the ED after an acute asthma exacerbation, a prescription for ICS will:
1. Improve usage of ICS as measured by refill of a prescription within the first 2 months after the ED visit
2. Improve symptom severity at two weeks after an ED visit as measured by days of cough, wheeze, missed school, daycare or work
3. Improve patient and caregiver asthma-related quality of life during the 2 months following an ED visit measured by asthma Health Related Quality of Life (HRQL)
4. Improve asthma control at 2 months as measured by a validated asthma instrument
Eligibility Criteria
Inclusion Criteria
- Age 12 months through 18 years
- History of asthma defined as 2 or more prior physician visits at which bronchodilators were prescribed
- Persistent symptoms identified by an asthma control tool based on the NAEPP Guidelines and developed and validated by a multidisciplinary team of clinicians from CHOP Allergy, Pulmonary Medicine, General Pediatrics and Emergency Medicine.
- Treated in ED for acute asthma with plan to discharge from the ED on oral prednisone
- Have a Primary Care Physician (PCP)
Exclusion Criteria
- Current hospitalization or admission to the extended day emergency care unit
- History of pediatric intensive care admission for asthma
- Current prescription for a controller medication such as inhaled corticosteroids (ICS), leukotriene receptor antagonists, or cromolyn
- Contraindications to the use of routine asthma medications including beta-agonists or systemic steroids
- Co-morbid disease: Chronic lung disease, for example cystic fibrosis; Congenital heart disease requiring surgery and/or medications; Sickle cell disease; Immunodeficiency syndromes
- Previous enrollment in the study
Data sourced from ClinicalTrials.gov (NCT00294398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.