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Recruiting

NCT Number: NCT07788534

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

Recruiting

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Key information

Conditions

Asthma Childhood

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Faisal Sepiclaized Hospital and Research Center, Jeddah, Mecca Region, Saudi Arabia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. correlations

    Time frame: 6 MONTH

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

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

    Time frame: 12 MONTH

Study contacts

Contact information is provided by the study sponsor or research team.

Abrar Barnawi

CONTACT

[email protected]

966551266326

Bader Alshrabi

CONTACT

[email protected]

966561681079

Sponsors and collaborators

Lead sponsor

King Faisal Specialist Hospital & Research Center

Other

Registry information

Official study title

FeNO Fractional Exhaled Nitric Oxide Test as Significant Tool in Enhancing Asthma Treatment Management Among Children

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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