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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.

23 augusti 2026 uppdaterad av: 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

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

80

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Saudiarabien
    • Mecca Region
      • Jeddah, Mecca Region, Saudiarabien
        • Aktiv, inte rekryterande
        • King Faisal Sepiclaized Hospital and Research Center
    • Western Region
      • Jeddah, Western Region, Saudiarabien, 21499
        • Rekrytering
        • king Faisal specialized hospital and research center
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Nariman Alrabie

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Övrig: 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
Diagnostiskt 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
Aktiv komparator: 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
Diagnostiskt 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
correlations
Tidsram: 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%.
Tidsram: 12 MONTH
12 MONTH

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

King Faisal Specialist Hospital & Research Center

Utredare

  • Huvudutredare: Nariman Alrabie, king Faisal specialized hospital and research center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

  • 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.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 november 2025

Primärt slutförande (Beräknad)

12 november 2026

Avslutad studie (Beräknad)

12 november 2026

Studieregistreringsdatum

Först inskickad

23 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

23 augusti 2026

Första postat (Faktisk)

26 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 2251240

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