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.

August 23, 2026 updated by: King Faisal Specialist Hospital & Research Center

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Saudi Arabia
    • Mecca Region
      • Jeddah, Mecca Region, Saudi Arabia
        • Active, not recruiting
        • King Faisal Sepiclaized Hospital and Research Center
    • Western Region
      • Jeddah, Western Region, Saudi Arabia, 21499
        • Recruiting
        • king Faisal specialized hospital and research center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nariman Alrabie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Feno based

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
Active Comparator: historical based

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
correlations
Time Frame: 6 MONTH
Establish correlations between FeNO levels and established asthma control markers such as ACT scores, eosinophils, and FEV1%.
6 MONTH
Establish correlations between FeNO levels and established asthma control markers such as ACT scores, eosinophils, and FEV1%.
Time Frame: 12 MONTH
12 MONTH

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King Faisal Specialist Hospital & Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nariman Alrabie, king Faisal specialized hospital and research center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 1. Al Frayh AR, Shakoor Z, Gad El Rab MO, Hasnain SM. Increased prevalence of asthma in Saudi Arabia. Ann Allergy Asthma Immunol. 2001;86(3):292-6. 2.Al Ghobain MO, Algazlan SS, Oreibi TM. Asthma prevalence among adults in Saudi Arabia. Saudi Med J. 2018;39(2):179-84. 3.Verini M, Consilvio NP, Di Pillo S, Cingolani A, Spagnuolo C, Rapino D, et al. FeNO as a Marker of Airways Inflammation: The Possible Implications in Childhood Asthma Management. Journal of Allergy. 2010;2010:1-7. 4.Schoos A-MM, Christiansen CF, Stokholm J, Bønnelykke K, Bisgaard H, Chawes BL. FeNO and exercise testing in children at risk of asthma. The Journal of Allergy and Clinical Immunology: In Practice. 2018;6(3):855-62. e2. 5.Beerthuizen T, Voorend-van Bergen S, van den Hout WB, Vaessen-Verberne AA, Brackel HJ, Landstra AM, et al. Cost-effectiveness of FENO-based and web-based monitoring in paediatric asthma management: a randomised controlled trial. Thorax. 2016;71(7):607-13. 6.Nguyen-Thi-Bich H, Duong-Thi-Ly H, Thom VT, Pham-Thi-Hong N, Dinh LD, Le-Thi-Minh H, et al. Study of the correlations between fractional exhaled nitric oxide in exhaled breath and atopic status, blood eosinophils, FCER2 mutation, and asthma control in Vietnamese children. Journal of Asthma and Allergy. 2016:163-70. 7.Czubaj-Kowal M, Nowicki GJ, Kurzawa R, Polak M, Ślusarska B. Factors Influencing the Concentration of Exhaled Nitric Oxide (FeNO) in School Children Aged 8-9-Years-Old in Krakow, with High FeNO Values≥ 20 ppb. Medicina. 2022;58(2):146.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 12, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2251240

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings