This study aims to evaluate whether incorporating FeNO monitoring into routine pediatric asthma care improves clinical outcomes relative to a historical cohort managed without FeNO
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
80
Registration: Eligible participants will be registered consecutively during clinic visits after obtaining informed consent (and assent where applicable). * Randomization: As this is an observational study comparing prospective data with historical controls, no randomization will be performed. 2.4 Data Gathering Methods * Prospective FeNO Group: Monthly data collection over 3 months including ACT/ C-ACT questionnaires, FeNO measurements using portable point-of-care devices, spirometry (FEV1%), and peripheral blood eosinophil counts. * Historical Control Group: Extraction of relevant clinical data (ACT/C-ACT scores, spirometry, eosinophil counts, ICS adherence, and exacerbation records) from electronic medical records covering a comparable 3-month timeframe. 2.5 Procedures and Central Laboratories * FeNO measurements will be conducted using a validated, portable FeNO device standardized across study sites. * Spirometry will be performed according to American Thoracic Society guidelines
Registration: Eligible participants will be registered consecutively during clinic visits after obtaining informed consent (and assent where applicable). * Randomization: As this is an observational study comparing prospective data with historical controls, no randomization will be performed. 2.4 Data Gathering Methods * Prospective FeNO Group: Monthly data collection over 3 months including ACT/ C-ACT questionnaires, FeNO measurements using portable point-of-care devices, spirometry (FEV1%), and peripheral blood eosinophil counts. * Historical Control Group: Extraction of relevant clinical data (ACT/C-ACT scores, spirometry, eosinophil counts, ICS adherence, and exacerbation records) from electronic medical records covering a comparable 3-month timeframe. 2.5 Procedures and Central Laboratories * FeNO measurements will be conducted using a validated, portable FeNO device standardized across study sites. * Spirometry will be performed according to American Thoracic Society guidelines
King Faisal Sepiclaized Hospital and Research Center
Jeddah, Mecca Region, Saudi Arabia
ACTIVE_NOT_RECRUITINGking Faisal specialized hospital and research center
Jeddah, Western Region, Saudi Arabia
RECRUITINGcorrelations
Establish correlations between FeNO levels and established asthma control markers such as ACT scores, eosinophils, and FEV1%.
Time frame: 6 MONTH
Establish correlations between FeNO levels and established asthma control markers such as ACT scores, eosinophils, and FEV1%.
Time frame: 12 MONTH
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