Asthma Management Program for Childhood Asthma

Not currently recruiting at 1 trial location

Overseen By Marina Reznik, MD, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Congenital heart disease, Cystic fibrosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a school-based program can help urban children with asthma manage their symptoms better by facilitating physical activity. The program focuses on educating children and their caregivers about asthma and staying active, while also training school staff to support these efforts. Participants will receive either specialized asthma management guidance (Asthma-PASS) or basic asthma education. The trial seeks children in kindergarten through 5th grade in Bronx schools who have been diagnosed with persistent or not well-controlled asthma. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance asthma management for children in schools.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this multifaceted school-based intervention is safe for urban schoolchildren with asthma?

Research has shown that increasing physical activity can help manage asthma symptoms in children. The treatment in this trial, called Asthma-PASS, supports children with asthma by encouraging exercise and ensuring they follow their doctor's advice. The trial includes activities and educational sessions at school to help manage asthma more effectively.

Asthma-PASS lacks specific safety data because it focuses on changing behaviors rather than introducing a new drug or medical procedure. The involvement of healthcare providers and community workers emphasizes careful management and support. This approach is generally considered safe, as it builds on existing asthma management strategies. The trial is labeled as "Not Applicable" in phase, indicating it tests the program's effectiveness rather than addressing safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Asthma-PASS program for childhood asthma because it takes a holistic and collaborative approach that goes beyond standard treatments like inhalers or medications. It involves working closely with primary care providers to optimize asthma management and includes community health workers to ensure the care plan is followed. Additionally, it offers tailored education sessions for children and caregivers to boost self-confidence and encourages physical activity, all while raising asthma awareness in schools and training school personnel. This comprehensive strategy could lead to better asthma control and improved quality of life for children.

What evidence suggests that this trial's treatments could be effective for childhood asthma?

Research has shown that physical activity plays a crucial role in managing asthma in children. One study found that children who participated in a school program promoting exercise and asthma education achieved better asthma control, with improvements persisting even after the program ended. Another study demonstrated that asthma programs involving community health workers also enhanced asthma control over time. The Asthma-PASS program, which combines exercise and asthma education, is being tested in this trial as one intervention. It may help reduce asthma symptoms and improve the quality of life for children in urban areas. Meanwhile, the Asthma Management Comparison Group will receive basic asthma education and notification to primary care providers about the child's asthma severity level. ^{1 6 7 8 9}

Who Is on the Research Team?

Marina Reznik, MD, MS

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for children in kindergarten to 5th grade with physician-diagnosed asthma, attending Bronx schools. They must have mild persistent or more severe asthma and be able to participate in physical activities. Caregivers must consent and speak English or Spanish. Children with other significant medical conditions, involved in another asthma study, or unable to stay in the area for 6 months are excluded.

Inclusion Criteria

My asthma is persistent or severe, or not controlled by my current treatment.

I am a student in grades K-5 in a Bronx elementary school.

I can speak and understand either English or Spanish.

Exclusion Criteria

My child has a serious health condition like heart disease or cystic fibrosis.

Family plans to leave the school or city in less than 6 months

Children in foster care or other situations in which consent cannot be obtained from a guardian

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Asthma-PASS intervention or asthma management comparison group activities, including asthma education sessions and collaboration with PCPs

12 months

Regular school-based sessions

Follow-up

Participants are monitored for asthma morbidity, physical activity, and other clinical outcomes

3-12 months

Assessments at 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Asthma-PASS
• Basic Asthma Management (AM)
• Child/Caregiver Education session

Trial Overview The Asthma-PASS program aims to reduce barriers to physical activity (PA) for urban schoolchildren with asthma by providing a multifaceted intervention that includes education sessions on managing asthma effectively and promoting increased PA as part of their treatment plan.

How Is the Trial Designed?

Group I: Asthma-PASS Intervention Experimental Treatment 2 Interventions

Collaboration with PCPs to optimize management. Community Health Worker (CHW) to ensure PCP plan is followed. Two asthma education sessions with children/caregivers focusing on self-efficacy and physical activity promotion. Promotion of asthma awareness in school. School personnel training in asthma

Group II: Asthma Management Comparison Group Active Control 2 Interventions

Includes two sessions of basic asthma education and PCP notification of child's asthma severity level.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

University of Rochester

Collaborator

Trials

883

Recruited

555,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

A comprehensive analysis of 372,345 spontaneous reports from 2011 to 2017 identified 385 different safety signals related to asthma medications in children, with a notable focus on psychiatric events, highlighting the importance of monitoring these drugs in the pediatric population.

The study uncovered new safety signals, such as herpes viral infections linked to omalizumab and hypertrichosis associated with budesonide, emphasizing that age stratification is crucial for detecting unique risks in children that may not be evident in the broader population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports. Baan, EJ., de Smet, VA., Hoeve, CE., et al.[2021]

A systematic review of 46 studies on pediatric asthma medications revealed that inhaled corticosteroids (ICS) are associated with 174 adverse drug events (ADE), including potential issues like adrenal and growth suppression.

Serious adverse drug events were rare, occurring in 0.9-6% of cases, and there were no confirmed deaths in pediatric patients, although methodological concerns were noted regarding the identification and assessment of ADE in the studies reviewed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of adverse drug events associated with administration of common asthma medications in children. Leung, JS., Johnson, DW., Sperou, AJ., et al.[2022]

A review of 326 spontaneous adverse drug reaction reports for asthma medications in children revealed that approximately 85% of these reports were serious, including six fatal cases, highlighting significant safety concerns.

The most commonly reported adverse reactions were psychiatric disorders (13%), respiratory issues (10%), and skin disorders (9%), with budesonide, salbutamol, and fluticasone being the medications with the highest number of reported ADRs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paediatric adverse drug reactions following use of asthma medications in Europe from 2007 to 2011. Aagaard, L., Hansen, EH.[2021]

A family-based asthma education program significantly improved the quality of life for both children with asthma and their parents, as shown in a study involving 34 families in each group over a 12-month period.

Children with non-allergic asthma in the experimental group demonstrated better pulmonary function, specifically in forced expiratory maneuvers, compared to the control group, highlighting the program's effectiveness in managing asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Family Empowerment Education on Pulmonary Function and Quality of Life of Children With Asthma and Their Parents in Tunisia: A Randomized Controlled Trial. Dardouri, M., Sahli, J., Ajmi, T., et al.[2021]

Asthma prevalence in children has dramatically increased by 160% since 1980, affecting nearly 5 million children in the U.S., highlighting the urgent need for effective management strategies.

The National Asthma Education and Prevention Program recommends a comprehensive, stepwise approach to asthma management, emphasizing regular monitoring, control of triggers, and the use of inhaled corticosteroids as the most effective long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of asthma in children. Kemp, JP., Kemp, JA.[2007]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5296627/

Pediatric asthma severity score is associated with critical ... A higher PASS is associated with a longer time on continuous albuterol, an increased likelihood to require noninvasive ventilation, and a longer stay in the ICU ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9510812/

Evaluating the effect of childhood and adolescence asthma ... One previous study demonstrated that initiating maintenance therapy for asthma was associated with 90% reduction in the family costs of asthma and a 20% ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772829325000190

Multicomponent intervention for schoolchildren with asthma Physical activity (PA) is an important factor in asthma management. However, studies report low PA in children with asthma living in underserved communities.

4. adc.bmj.com adc.bmj.com/content/110/6/422

Analysis of the asthma scores recommended in guidelines ... Overall, 83/158 (53%) guidelines recommend a bedside clinical score for assessment of asthma severity.

5. ajph.aphapublications.org ajph.aphapublications.org/doi/full/10.2105/AJPH.2021.306272

Community Health Worker Asthma Interventions for Children Both intervention groups showed significant improvement in asthma control scores over time. Asthma control was maintained after interventions ended.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7593416/

Pediatric acute asthma scoring systems: a systematic ... A systematic review was undertaken to identify the parameters collected in pediatric asthma severity scores.

7. aafa.org aafa.org/asthma/asthma-facts/

Asthma Facts In 2021, 38.7% of children ages 18 and younger who had asthma reported having one or more asthma attacks in the past year. · According to the Centers for Disease ...

8. cps.ca cps.ca/en/documents/position/managing-an-acute-asthma-exacerbation

Managing an acute asthma exacerbation in children This statement addresses the assessment, management, and disposition of paediatric patients with a known diagnosis of asthma who present with an acute asthma ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2688115224006854

Emergency department treatment of asthma in children This review focuses on the optimal approach to diagnosis and treatment of children with acute asthma exacerbations who present to the ED.