FeNO Fractional Exhaled Nitric Oxide Test as Significant Tool in Enhancing Asthma Treatment Management Among Children
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 14
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Saudi Arabia
King Faisal Sepiclaized Hospital and Research Center
ACTIVE_NOT_RECRUITING
Jeddah
king Faisal specialized hospital and research center
RECRUITING
Jeddah
Contact Information
Primary
Abrar Barnawi
abarnawi1@kfshrc.edu.sa
966551266326
Backup
Bader Alshrabi
balshrabi@kfshrc.edu.sa
966561681079
Time Frame
Start Date: 2025-11-12
Estimated Completion Date: 2026-11-12
Participants
Target number of participants: 80
Treatments
Other: Feno based
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
Active_comparator: historical based
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
Related Therapeutic Areas
Sponsors
Leads: King Faisal Specialist Hospital & Research Center