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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-14
SponsorKing Faisal Specialist Hospital & Research Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • FENO

    Diagnostic test

    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

  • PFT

    Diagnostic test

    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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Feno basedOther 1 intervention
Group B: historical basedActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

correlations

Establish correlations between FeNO levels and established asthma control markers such as ACT scores, eosinophils, and FEV1%.

Time frame
6 MONTH
2

Establish correlations between FeNO levels and established asthma control markers such as ACT scores, eosinophils, and FEV1%.

Time frame
12 MONTH

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.