Asthma ChildhoodNCT07788534
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.
A study testing FENO and PFT in people with Asthma Childhood, run by King Faisal Specialist Hospital & Research Center at 2 sites in Saudi Arabia.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Asthma Childhood
- What is being tested?
- FENO and PFT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- 12 Nov 2025to 12 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia2 sites, 1 recruiting
- Active, not recruiting
King Faisal Sepiclaized Hospital and Research Center
Jeddah, Mecca Region
- Recruiting
king Faisal specialized hospital and research center
Jeddah, Western Region, 21499
Abrar Barnawi, 966551266326, abarnawi1@kfshrc.edu.sa
bader Alshrabi, 966561681079, balshrabi@kfshrc.edu.sa
About this study
Official title: 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
- Conditions
- Asthma Childhood
- Being tested
- FENO, PFT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FENODiagnostic 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
PFTDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Feno based | Other | 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 Receives: Diagnostic Test: FENO |
| historical based | Active comparator | 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 Receives: Diagnostic Test: PFT |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlations
Establish correlations between FeNO levels and established asthma control markers such as ACT scores, eosinophils, and FEV1%.
Measured: 6 MONTH
Establish correlations between FeNO levels and established asthma control markers such as ACT scores, eosinophils, and FEV1%.
Measured: 12 MONTH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start12 Nov 2025
- Primary completion12 Nov 2026 (estimated)
- Study completion12 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Faisal Specialist Hospital & Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nariman Alrabie, Principal investigator, king Faisal specialized hospital and research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788534
- Sponsor's protocol ID
- 2251240
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FeNO Fractional Exhaled Nitric Oxide Test as Significant Tool in Enhancing Asthma Treatment Management Among Children
- ClinicalTrials.gov ID
- NCT07788534
- Acronym / sponsor ID
- 2251240
- Conditions
- Asthma Childhood
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- King Faisal Specialist Hospital & Research CenterUniversity, hospital or other
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 12 Nov 2026 (estimated)
- Study completion
- 12 Nov 2026 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feno based | Other | Diagnostic Test: FENORegistration: 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 |
| historical based | Active comparator | Diagnostic Test: PFTRegistration: 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 |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 6 to 14 years with a physician-diagnosed asthma.
Key exclusion criteria (3 listed)
- Presence of other chronic pulmonary diseases (e.g., cystic fibrosis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FENORegistration: 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 based |
| PFTRegistration: 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 | historical based |
Primary outcome
correlations
Time frame: 6 MONTH
Establish correlations between FeNO levels and established asthma control markers such as ACT scores, eosinophils, and FEV1%.
Establish correlations between FeNO levels and established asthma control markers such as ACT scores, eosinophils, and FEV1%.
Time frame: 12 MONTH
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Results publication1. 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nariman Alrabie principal investigator
king Faisal specialized hospital and research center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FENO and PFT in people with Asthma Childhood, run by King Faisal Specialist Hospital & Research Center at 2 sites in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abrar Barnawi (966551266326, abarnawi1@kfshrc.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlations (time frame: 6 MONTH). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07788534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.