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临床试验/NCT07230912
NCT07230912尚未招募不适用

Impact of Comorbidities, Some Biomarkers, Micro RNA in Childhood Asthma Phenotypes, Severity and Response to Therapy

Assiut University0 个研究点目标入组 82 人开始时间: 2025年12月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
82
主要终点
-proportion of participants achieving clinical treatment response (forced expiratory volume in one second (FEV1) increase >12% from baseline). -association between baseline circulating micro RNA (miR-223-3p- miR-191-5p) and clinical treatment response.

研究概览

简要总结

  • Assess response to treatment in children with bronchial asthma attending Assiut university children hospital.
  • Role of comorbidities in controlling symptoms of bronchial asthma.
  • Evaluate the role of the soluable interleukin 5 receptor, I C-telopeptide of type I collagen (ICTP), miR-223-3p and miR-191-5p in bronchial asthma.

详细描述

Asthma is a heterogenous disease usually characterized by chronic air way inflammation. It is defined by the history of respiratory symptoms such as wheeze, shortness of breath, chest tightness and cough. Asthma affects approximately 300 million people around the world causing about 1,000 deaths per day.

The overall prevalence of asthma among children and adolscents in Eastern Mediterranean Regional Office (EMRO) countries was 10.61%, Among the countries studied, Qatar exhibited the highest prevalence at 16.69%, Egypt (8.85%), Adolescents showed a slightly higher prevalence of asthma at 10.10% compared to children at 9.70%. Boys exhibited a higher prevalence at 11.48% compared to girls at 9.75%. Urban areas demonstrated a higher prevalence at 11.27% than rural areas at 8.29%.

In recent decades, both asthma prevalence and incidence have been increasing worldwide, not only due to the genetic background, but mainly to the effect of a wide number of environmental risk factors, many of which included under the umbrella of "modern lifestyle". However, the worldwide economic globalization could also have contributed to a significant increase in the asthma burden, even in developing countries that presented a low disease prevalence in the recent past.

Severe asthma is an important health burden as children with severe asthma are prone to medication related side effects, life threatening exacerbations, and impaired quality of life. Progressive air flow limitation is also a feature of severe asthma. Most importantly, poor asthma control leads to poor quality of life in children and caregivers.

Comorbidities such as cardiovascular, metabolic, endocrine, respiratory, and psychiatric diseases are prevalent in asthma, owing to chronic inflammation, systemic corticosteroid use, reduced physical activity, and poor sleep.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 6-12 years diagnosed asthma, inpatient or attending pediatric outpatient clinic of Assiut university children hospital.

排除标准

  • - Chronic respiratory illness other than asthma (e.g., bronchiectasis, CF)
  • Known immunodeficiency or systemic illness
  • patients with skeletal deformities
  • patients suspected inborn errors of metabolism

研究组 & 干预措施

comparing the mean of FEV1 between two independent groups(comorbidity in bronchial asthma )

干预措施: Short Acting Beta 2 Agonist (Drug)

结局指标

主要结局

-proportion of participants achieving clinical treatment response (forced expiratory volume in one second (FEV1) increase >12% from baseline). -association between baseline circulating micro RNA (miR-223-3p- miR-191-5p) and clinical treatment response.

时间窗: one year

* number and percentage of children showing improvment in lung function defined as an increase in forced expiratory volume in one second \>12 from baseline measured by standardized spirometry (pre and post bronchodilator) at one year. * correlation and between- group differences in baseline serum micoRNA levels (miR-223-3p- miR-191-5p) comparing responders vs non-responders in 1 year.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aghapy Gamal Zahy Shafik

Assistant lecteurer of pediatrics

Assiut University

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