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Establishing a patient registry study database of dust mite allergic asthma in children: design, methodology and
Juan Zhou1,2,3, Weiguo Li1,2, Xiang Wen1,2
1Department of Respiratory Medicine, Children's Hospital of Chongqing Medical University, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing, China.
Insights
This study established a patient registry for childhood dust mite allergic asthma (DMAA), identifying key characteristics and potential biomarkers. Further analysis aims to personalize treatments for pediatric asthma patients.
Area of Science:
- Pediatric Allergy and Immunology
- Respiratory Medicine
- Clinical Research Methods
Background:
- Asthma is a complex respiratory condition with diverse patient subgroups.
- Dust mite allergic asthma (DMAA) is the predominant asthma phenotype in children.
- Patient registry studies offer comprehensive real-world clinical insights compared to traditional trials.
Purpose of the Study:
- To establish a patient registry database for childhood DMAA.
- To identify clinical characteristics and potential biomarkers associated with DMAA.
- To lay the groundwork for individualized treatment strategies in pediatric asthma.
Main Methods:
- Enrolled 208 children diagnosed with DMAA at a specialized pediatric asthma clinic (August 2018 - August 2020).
- Collected comprehensive clinical data, laboratory test results, and peripheral blood samples following informed consent.
- Utilized a patient registry study (PRS) design to capture real-world patient data.
Main Results:
- The DMAA cohort comprised predominantly males, with over 50% reporting allergic rhinitis, cesarean section history, family history of allergy, and passive smoking exposure.
- Elevated eosinophil counts and total immunoglobulin E (IgE) levels were observed compared to normal ranges.
- Children with uncontrolled asthma exhibited higher hemoglobin (Hb) levels. Those with persistent abnormal pulmonary function were older, had longer disease duration, and higher fractional exhaled nitric oxide (FeNO) and Hb levels.
Conclusions:
- A preliminary patient registry database for childhood DMAA has been successfully established.
- Cluster analysis of registry data and blood samples can elucidate distinct pathophysiological mechanisms.
- This research facilitates the development of more personalized and targeted therapeutic interventions for pediatric asthma.
Background:
Asthma is a heterogeneous disease with different phenotypes, endotypes and responses to treatment. Dust mite allergic asthma (DMAA) is the most common type in children. Compared with randomized control trials, a patient registry study (PRS) can reflect the real physical condition and clinical diagnosis more comprehensively.
Methods:
Children who visited the asthma clinic of the Children's Hospital of Chongqing Medical University between August 2018 and August 2020, and met the inclusion criteria and also agreed to participate, were enrolled in the registry study. Clinical information, laboratory tests and peripheral blood samples were collected after informed consent was given by guardians.
Results:
To date, 208 children have been enrolled in the patient registry database of DMAA. They are mainly male, with >50% having a history of allergic rhinitis, cesarean section, positive family history and passive smoking. Eosinophils and total immunoglobulin E levels were all significantly higher than normal. According to results for the childhood asthma control test (c-ACT) and ratio of forced expiratory volume in 1 s to predicted value after inhaled corticosteroid treatment, the uncontrolled group had higher hemoglobin (Hb) levels than the control group. The group exhibiting abnormal pulmonary function was older, and had longer disease duration, higher fractional exhaled nitric oxide and Hb than the group in which pulmonary function was restored.
Conclusions:
We have preliminarily established a registered study database of children with DMAA. By cluster analysis and using blood samples, we can further study the different pathophysiological mechanisms in order to provide more individualized and targeted treatments for all children.
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