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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.

NCT07788534 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-08-26

No results posted yet for this study

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

Conditions

  • Asthma Childhood

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

Sponsors & Collaborators

  • King Faisal Specialist Hospital & Research Center

    lead OTHER

Principal Investigators

  • Nariman Alrabie · king Faisal specialized hospital and research center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-12
Primary Completion
2026-11-12
Completion
2026-11-12

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07788534 on ClinicalTrials.gov