Asthma Management Program for Childhood Asthma

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

452 Participants Needed

Trial Summary

What is the purpose of this trial?

Physical activity (PA) is an important component of asthma management in children. Studies show that PA is associated with decreased severity of asthma symptoms, as well as improved disease control and quality of life. However, urban minority children with asthma face barriers to PA on multiple levels.The goal of this research project is to evaluate whether a multifaceted school-based intervention that addresses key barriers to physical activity reduces asthma morbidity among urban schoolchildren with asthma.

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 data supports the effectiveness of the Asthma Management Program for Childhood Asthma treatment?

Research shows that educational information and behavioral asthma management techniques are considered very useful by families, leading to improvements in asthma management. Additionally, parents reported high satisfaction with the program, noting better coping skills and knowledge about asthma in their children. ^{1 2 3 4 5}

Is the Asthma Management Program for Childhood Asthma safe for children?

The safety of asthma treatments in children is important, and while specific safety data for the Asthma Management Program isn't detailed, general safety information for asthma medications shows that adverse reactions can occur but are often rare. It's crucial to monitor for any side effects and consult healthcare providers for guidance. ^{6 7 8 9 10}

How is the Asthma-PASS treatment different from other asthma treatments?

The Asthma-PASS treatment is unique because it incorporates a comprehensive 'five-in-one' management approach, which includes standardized asthma treatment, an asthma diary, peak expiratory flow monitoring, a reasonable diet, and physical exercise. This holistic approach not only improves lung function but also reduces the number of acute asthma attacks and increases parental satisfaction compared to routine medication and regular outpatient consultations. ^{5 11 12 13 14}

Research Team

Marina Reznik, MD, MS

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Treatment satisfaction with an asthma management program: a "five"-year retrospective assessment. [2019]

3. Austria pubmed.ncbi.nlm.nih.gov

[Parental satisfaction with an outpatient asthma-management program for children and adolescents--a pilot study]. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The Childhood Asthma Management Program (CAMP): design, rationale, and methods. Childhood Asthma Management Program Research Group. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

The prevalence of environmental exposure to perceived asthma triggers in children with mild-to-moderate asthma: data from the Childhood Asthma Management Program (CAMP). [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Challenges in assessing outcomes for pediatric asthma. [2019]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

A systematic review of adverse drug events associated with administration of common asthma medications in children. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Management of asthma in children. [2007]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Paediatric adverse drug reactions following use of asthma medications in Europe from 2007 to 2011. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Pediatric Boot Camp Series: Longitudinal Care for a Child With Asthma-From the Emergency Department to Outpatient Clinic. [2022]

12. China pubmed.ncbi.nlm.nih.gov

[Influence of five-in-one management mode on disease prevention and control of school children with asthma]. [2020]

13. Spain pubmed.ncbi.nlm.nih.gov

[Evaluation of activities and effectiveness of an asthmatic child program developed in primary care]. [2016]

14. United States pubmed.ncbi.nlm.nih.gov

Neurocognitive functioning in children with mild and moderate asthma in the childhood asthma management program. The Childhood Asthma Management Program (CAMP) Research Group. [2019]