What side effects are associated with this type of intervention?

Common treatments for childhood asthma include inhaled corticosteroids (ICS), long-acting beta agonists (LABAs), and leukotriene receptor antagonists like montelukast. ICS can cause side effects such as oral thrush, hoarseness, and, in rare cases, reduced growth velocity. LABAs, when used in combination with ICS, are generally safe but can sometimes lead to headaches, throat irritation, and muscle cramps. Montelukast is associated with side effects like abdominal pain, headache, and, less commonly, neuropsychiatric events such as agitation, depression, and suicidal thoughts.

What prior FDA approvals exist?

The FDA has approved several treatments for childhood asthma, including inhaled corticosteroids (ICS) like fluticasone and beclomethasone, which are foundational in asthma management. Long-acting beta-agonists (LABAs) such as salmeterol are often used in combination with ICS for better control. Leukotriene receptor antagonists (LTRAs) like montelukast are also approved and used as add-on therapy. Additionally, biologics such as omalizumab (anti-IgE) and mepolizumab (anti-IL-5) have been approved for severe asthma in children, particularly those with specific phenotypes like eosinophilic asthma. These treatments align with the multifaceted intervention study aimed at improving adherence to asthma care guidelines.

What other types of research exist?

Promising novel alternatives for childhood asthma treatment in 2024 include: 1) Integrated computerized asthma management systems in emergency departments, which streamline workflow and provide real-time asthma scoring and reminders. 2) Use of impulse oscillometry for more accurate assessment and monitoring of asthma control in children. 3) Telehealth services to improve access to care and ensure continuous monitoring and management of asthma. 4) Biologic therapies such as mepolizumab and reslizumab for children with severe, eosinophilic asthma, which target specific pathways involved in asthma inflammation.

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Technology-Based Asthma Care Intervention for Childhood Asthma (PRAGMATIC Trial)

N/A

Waitlist Available

Led By Marina Reznik, MD, MS

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

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

Must have

Physician-diagnosed asthma (based on EHR)

Age 2 and 12 years, inclusive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to improve asthma care for urban children aged 2-12 with severe or poorly controlled asthma. It involves educating doctors through electronic records and having outreach workers assist in managing the children's care. The goal is to ensure better treatment and reduce asthma-related problems.

Who is the study for?

This trial is for children aged 2-12 with physician-diagnosed asthma that's persistent or uncontrolled, as per specific guidelines. The caregiver must speak English or Spanish and give consent, along with the child's assent if they're over 7 years old. It excludes those without phone access, in foster care, or with conditions like heart disease or cystic fibrosis.

What is being tested?

The study tests a technology-based intervention called PRAGMATIC in urban primary care settings to see if it improves guideline-based asthma care and reduces symptoms among urban kids with serious asthma.

What are the potential side effects?

Since this trial focuses on a prompting intervention rather than medication, traditional side effects are not applicable. However, there may be indirect impacts related to changes in management of the child’s asthma.

Eligibility Criteria

Inclusion Criteria

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

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My doctor has diagnosed me with asthma.

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I am between 2 and 12 years old.

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My asthma is uncontrolled according to my doctor's assessment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 5 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

Proportion of visits with >1 guideline-based corrective actions

Secondary study objectives

Symptom free days

Other study objectives

Health care utilization: number hospitalizations for asthma

Health care utilization: number of ED visits for asthma

Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ)

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: PRAGMATICExperimental Treatment1 Intervention

Intervention practices will receive guideline information and assess children's asthma severity and control. For children with persistent/uncontrolled asthma, academic detailing and prompt in EHR following asthma guidelines will guide asthma management; outreach worker will follow up with patients referred to the by providers to receive care coordination to assure that provider management plan is followed by patient at home.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PRAGMATIC

2017

N/A

~530

0 / 3Eligibility 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 short-acting beta agonists (SABAs), inhaled corticosteroids (ICS), and long-acting beta agonists (LABAs) combined with ICS. SABAs work by quickly relaxing the bronchial muscles, providing rapid relief from acute symptoms such as wheezing and shortness of breath. ICS help reduce airway inflammation, thereby decreasing the frequency and severity of asthma attacks. LABAs, when used with ICS, offer prolonged bronchodilation and enhanced anti-inflammatory effects, making them effective for long-term asthma control. These treatments are essential for managing childhood asthma as they address both immediate symptoms and underlying inflammation, improving overall asthma control and reducing the risk of severe exacerbations.