An interventional study of FENO and PFT in Asthma Childhood, sponsored by King Faisal Specialist Hospital & Research Center. Recruiting at 2 sites in Saudi Arabia. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by King Faisal Specialist Hospital & Research Center · Not applicable, Interventional, and Health services research
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
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's planned enrollment of 80 is close to the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →King Faisal Specialist Hospital & Research Center is the lead sponsor of 99 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Children aged 6 to 14 years with a physician-diagnosed asthma.
Exclusion Criteria:
Presence of other chronic pulmonary diseases (e.g., cystic fibrosis).
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 Test: FENO
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 Test: PFT
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
correlations
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
Not enrolling at this site.
Plan to share: No
Started Nov 2025 (actual). Primary completion is estimated for Nov 2026, 12 months after the start.
Of 599 non-industry interventional studies with no phase under Asthma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's planned 12 months is below that.
Counting every sponsor, half of 649 studies reached it within 23 months; a quarter within 10 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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King Faisal Specialist Hospital & Research Center