Asthma Clinical Trial
Official title:
Inhaled Corticosteroids After a Pediatric Emergency Visit for Asthma
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
Abstract.
Background: Asthma prevalence, emergency visits, and hospitalizations have increased
substantially, especially among young children and urban populations. Although inhaled
corticosteroids (ICS) are the mainstay of treatment for persistent asthma, studies have
demonstrated a low rate of ICS usage and primary care provider follow-up within a month of
an Emergency Department (ED) visit. Furthermore, ICS usage and adherence with National
Asthma Education and Prevention Program (NAEPP) recommendations is low even for children
that follow-up with their primary care physician (PCP). In addition, other studies have
demonstrated frequent symptoms, activity restriction, and missed school or work during the
weeks following an ED visit. Prescribing ICS at ED discharge occurs uncommonly in the United
States based on surveys and reviews of current practice. Adult studies have been
inconclusive and the role of ICS after a pediatric emergency visit for asthma has not been
studied. This study will assess the short-term outcomes of prescribing ICS to young children
with persistent asthma symptoms after an emergency visit for asthma.
Objective: To determine whether a prescription for ICS added to standard asthma ED discharge
therapy to young children with persistent asthma increases adherence to NAEPP guidelines for
ICS usage at 2 months follow up and improves short-term symptoms and quality of life for
patient and caregiver.
Methods: Randomized control trial of children 1- 8yo of age with persistent asthma being
discharged after an emergency visit for asthma. Subjects will be randomized to receive
standard therapy of oral corticosteroid, albuterol, and education versus standard care plus
a prescription for budesonide once daily. A questionnaire will be administered at baseline,
with follow-up telephone interviews conducted at 2 weeks and 2 months. Pharmacy verification
of refill of a second prescription of ICS will be the primary outcome. Asthma symptoms and
quality of life will be assessed as secondary outcomes.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04624425 -
Additional Effects of Segmental Breathing In Asthma
|
N/A | |
| Terminated |
NCT04410523 -
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
|
Phase 2 | |
| Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
N/A | |
| Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
| Recruiting |
NCT03694158 -
Investigating Dupilumab's Effect in Asthma by Genotype
|
Phase 4 | |
| Terminated |
NCT04946318 -
Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma
|
Phase 2 | |
| Completed |
NCT04450108 -
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
|
N/A | |
| Completed |
NCT03086460 -
A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)
|
Phase 2 | |
| Completed |
NCT01160224 -
Oral GW766944 (Oral CCR3 Antagonist)
|
Phase 2 | |
| Completed |
NCT03186209 -
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
|
Phase 3 | |
| Completed |
NCT02502734 -
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
|
Phase 3 | |
| Completed |
NCT01715844 -
L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics
|
Phase 1 | |
| Terminated |
NCT04993443 -
First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036
|
Phase 1 | |
| Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
| Recruiting |
NCT06033833 -
Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
|
Phase 2 | |
| Completed |
NCT03257995 -
Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
|
Phase 2 | |
| Completed |
NCT02212483 -
Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
|
N/A | |
| Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
| Withdrawn |
NCT01468805 -
Childhood Asthma Reduction Study
|
N/A | |
| Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|