Asthma Childhood
Conditions
Brief summary
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
Interventions
DIAGNOSTIC_TESTFENO
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
DIAGNOSTIC_TESTPFT
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
Sponsors
King Faisal Specialist Hospital & Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 6 to 14 years with a physician-diagnosed asthma. * Minimum of three months' follow-up at the pediatric respiratory clinic. * Availability of Asthma Control Test (ACT/C-ACT) scores and clinical data
Exclusion criteria
* Presence of other chronic pulmonary diseases (e.g., cystic fibrosis). * Recent respiratory infections within four weeks prior to enrollment. * Current treatment with biologic agents affecting asthma inflammation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| correlations | 6 MONTH | Establish correlations between FeNO levels and established asthma control markers such as ACT scores, eosinophils, and FEV1%. |
| Establish correlations between FeNO levels and established asthma control markers such as ACT scores, eosinophils, and FEV1%. | 12 MONTH | — |
Countries
Saudi Arabia
Contacts
CONTACTAbrar Barnawi
CONTACTBader Alshrabi
PRINCIPAL_INVESTIGATORNariman Alrabie
king Faisal specialized hospital and research center
Outcome results
None listed