Recruiting
This Study Aims to Compare Asthma Control in Children Monitored With FeNO Against a Historical Cohort Without FeNO. Secondary Objectives Include Evaluating Associations Between FeNO Levels, ACT/C-ACT Scores, Eosinophil Counts, FEV1%, ICS Adherence, and Exacerbation Frequency.
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
ClinicalTrials.gov IDNCT07788534
PhaseNA
Enrollment80
SponsorKing Faisal Specialist Hospital & Research Center
Age6 Years – 14 Years
SexALL
Conditions studied
Asthma Childhood
About this study
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 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
Primary outcomes
- correlations (6 MONTH)
- Establish correlations between FeNO levels and established asthma control markers such as ACT scores, eosinophils, and FEV1%. (12 MONTH)
Eligibility information
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.
Study locations
- King Faisal Sepiclaized Hospital and Research Center, Jeddah, Mecca Region Saudi Arabia
- king Faisal specialized hospital and research center, Jeddah, Western Region 21499 Saudi Arabia
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-21.