- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07137923
SMART & SIMPLE Asthma Treatment Study for Children and Teens
This important research study, called the SMART & SIMPLE Trial, focuses on improving asthma care for children and teenagers aged 5-18 years. Asthma remains one of the most common chronic conditions affecting children nationwide, causing significant health challenges and disruptions to daily life. The study specifically addresses how to better implement a proven asthma management strategy called Single Maintenance and Reliever Therapy (SMART) in real-world clinical practice.
Many children with moderate to severe asthma struggle with complex medication regimens that require multiple inhalers, which can lead to confusion, missed doses, and poor asthma control. The SMART approach simplifies treatment by using a single inhaler that contains both maintenance medication (taken regularly) and reliever medication (used as needed). This method has shown excellent results in international settings but hasn't been widely adopted in the United States healthcare system.
The study will compare two different approaches to implementing SMART therapy across pediatric clinics. Some clinics will continue with usual care while others will receive additional support including electronic health record prompts for providers and educational materials for families, nurses, and healthcare providers. The research team will carefully measure how these different approaches affect the adoption and continued use of SMART therapy over time.
For families participating in this research, the potential benefits include receiving cutting-edge asthma care that may lead to better symptom control, fewer asthma attacks, and simplified medication routines. The study acknowledges that managing childhood asthma requires a team approach involving healthcare providers, patients, and families working together toward better health outcomes.
This type of implementation research is critically important because it bridges the gap between scientific discoveries and real-world patient care. Even when effective treatments exist, they often take years to become standard practice. Studies like SMART & SIMPLE help accelerate this process by identifying the most effective ways to integrate new treatments into routine care, ultimately benefiting children with asthma and their families through improved access to evidence-based treatments and better health outcomes.
The research team includes experts from Children's Hospital of Philadelphia and is supported by the National Heart, Lung, and Blood Institute, ensuring high scientific standards and careful attention to patient safety. The study design includes proper oversight and monitoring to protect participants while gathering valuable information that could transform how asthma is managed for children across the country.
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