What side effects are associated with this type of intervention?

Common treatments for childhood asthma, such as those used in programs like Asthma CHAMPS, include inhaled corticosteroids, long-acting beta-agonists, leukotriene modifiers, and biologics. Inhaled corticosteroids can cause side effects like oral thrush, hoarseness, and, rarely, growth suppression. Long-acting beta-agonists may lead to headaches, throat irritation, and palpitations. Leukotriene modifiers can cause behavioral changes and gastrointestinal issues. Biologics, such as mepolizumab and omalizumab, may result in injection site reactions and, less commonly, anaphylaxis. Educational and environmental interventions generally have minimal side effects but require consistent adherence to be effective.

What prior FDA approvals exist?

FDA-approved treatments for childhood asthma include inhaled corticosteroids (ICS) like fluticasone and beclomethasone, long-acting beta-agonists (LABAs) such as salmeterol, and leukotriene receptor antagonists like montelukast. Biologics such as omalizumab, mepolizumab, and dupilumab are also approved for severe asthma with specific phenotypes. These treatments focus on controlling symptoms, reducing exacerbations, and improving overall asthma management, aligning with the multi-faceted approach of the Asthma CHAMPS program.

What other types of research exist?

<ol> <li>Open Airways: An educational program adapted for different sociodemographic populations, focusing on behavioral change and medication information, which has shown to increase parental confidence and early medication use. 2.</li> </ol> AIR WISE: An individually administered asthma self-management program that has demonstrated a reduction in emergency visits among high-utilizer children. 3. Biological Treatments: Mepolizumab and Dupilumab have shown efficacy and safety in managing severe eosinophilic asthma in children, providing targeted biological therapy as an alternative to traditional management programs.

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Asthma CHAMPS Program for Childhood Asthma

N/A

Recruiting

Led By Michelle N Ealin, PhD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Children with asthma diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help children in Baltimore City elementary schools manage their asthma better. The program teaches kids and their caregivers how to control asthma symptoms, reducing school absences and emergency healthcare visits.

Who is the study for?

This trial is for adults who care for children with asthma or staff at Baltimore City K-8 Public Schools. It includes kids diagnosed with asthma and enrolled in schools participating in Asthma CHAMPS. Those unwilling to consent, or children unwilling to provide assent are excluded.

What is being tested?

The study tests the Asthma CHAMPS program's effectiveness in reducing asthma disparities among children by implementing it across 32 elementary schools. The design involves a stepped wedge trial to assess its impact on school attendance, healthcare use, and overall asthma control.

What are the potential side effects?

Since this trial focuses on an educational and management program rather than medication, traditional side effects are not applicable. However, there may be indirect impacts related to changes in daily routines or stress levels due to new management practices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My child has been diagnosed with asthma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Asthma-related absences

Emergency Department (ED) utilization for asthma by children

Hospitalization for asthma by children

+1 more

Secondary study objectives

Acceptability of Intervention (AIM) as assessed by a 4 item questionnaire

Feasibility of Intervention (FIM) as assessed by a 4 item questionnaire

Intervention Appropriateness Measure (IAM) as assessed by a 4 item questionnaire

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: School staffExperimental Treatment2 Interventions

School staff in a K-8 school participating in Asthma CHAMPS

Group II: Children with asthmaExperimental Treatment2 Interventions

Aged 5-13 and enrolled in Baltimore City Public School participating in Asthma CHAMPS

Group III: Caregivers of children with asthmaExperimental Treatment2 Interventions

Caregiver of a child with asthma that is aged 5-13 enrolled in a Baltimore City Public School participating in Asthma CHAMPS

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for childhood asthma include inhaled corticosteroids (ICS), which reduce inflammation in the airways, and short-acting beta agonists (SABAs), which provide quick relief by relaxing bronchial muscles. Long-acting beta agonists (LABAs) are often used in combination with ICS for long-term control. The Asthma CHAMPS program emphasizes a multi-faceted approach, combining medical treatment with education, environmental control, and healthcare coordination. This comprehensive strategy is vital for childhood asthma patients as it not only addresses the immediate symptoms but also reduces exposure to triggers and ensures consistent management, leading to better overall asthma control and fewer exacerbations.