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Oxymetazoline Bridge Therapy With Intranasal Corticosteroids in Pediatric Allergic Rhinitis

12. maj 2026 opdateret af: Necmi Can Yüksel, MD, Dr. Behcet Uz Children's Hospital

Short-Term Nasal Decongestant as Bridge Therapy Combined With Intranasal Corticosteroids in Children With Persistent Allergic Rhinitis: A Randomized Controlled Trial

Persistent allergic rhinitis in children is commonly treated with intranasal corticosteroids (INS), which are considered first-line therapy. However, the delayed onset of action of INS may reduce patient adherence and delay symptom relief. This randomized controlled study evaluates whether adding short-term oxymetazoline nasal spray during the first 5 days of INS treatment ("bridge therapy") improves clinical outcomes, nasal airflow, quality of life, nasal inflammation, and medication adherence in children with persistent allergic rhinitis.

Children aged 4-18 years with moderate-to-severe persistent allergic rhinitis were randomized into two parallel groups. One group received mometasone furoate nasal spray alone for 4 weeks, while the other group received mometasone furoate combined with oxymetazoline during the first 5 days of treatment. Clinical symptoms, Peak Nasal Inspiratory Flow (PNIF), Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), Nasal Nitric Oxide (nNO), and Medication Adherence Rating Scale (MARS) scores were evaluated.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Allergic rhinitis is one of the most common chronic inflammatory diseases in childhood and significantly affects sleep quality, school performance, daily functioning, and quality of life. Intranasal corticosteroids (INS) are recommended as first-line therapy because of their strong anti-inflammatory effects. However, the onset of symptom relief may take several days or weeks, especially in patients with severe nasal congestion. This delayed onset may negatively affect treatment adherence and early treatment satisfaction.

Short-term use of topical nasal decongestants may provide rapid nasal patency and facilitate delivery of intranasal corticosteroids into the nasal cavity. This study investigates whether short-term oxymetazoline therapy added to the initiation of INS treatment can function as a "bridge therapy" in children with persistent allergic rhinitis.

This prospective randomized controlled study enrolled children aged 4-18 years diagnosed with moderate-to-severe persistent allergic rhinitis according to ARIA guidelines. Participants were randomized into two parallel treatment groups:

  1. Intranasal corticosteroid monotherapy group (mometasone furoate for 4 weeks)
  2. Combination therapy group (mometasone furoate for 4 weeks plus oxymetazoline during the first 5 days)

Clinical symptom severity was assessed using Total Nasal Symptom Score (TNSS). Objective nasal airflow was evaluated with Peak Nasal Inspiratory Flow (PNIF). Nasal inflammation was assessed using Nasal Nitric Oxide (nNO). Disease-specific quality of life was measured using the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), and treatment adherence was evaluated using the Medication Adherence Rating Scale (MARS).

The primary objective of the study is to determine whether bridge therapy improves symptom control compared with intranasal corticosteroid monotherapy. Secondary objectives include evaluating effects on nasal airflow, quality of life, nasal inflammation, and medication adherence.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

76

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
      • Izmir, Tyrkiet (Türkiye), 35180
        • Dr. Behcet Uz Pediatric Diseases and Surgery Training and Research Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Children aged 4 to 18 years
  • Diagnosis of moderate-to-severe persistent allergic rhinitis according to ARIA guidelines
  • Ability to comply with study procedures
  • Written informed consent obtained from parents or legal guardians

Exclusion Criteria:

  • Mechanical nasal obstruction (nasal polyposis, severe septal deviation, or adenoid hypertrophy)
  • Acute upper respiratory tract infection within the previous 2 weeks
  • Active smoking or significant passive smoke exposure
  • Current use of allergic rhinitis medications
  • Use of intranasal corticosteroids within the previous 3 months
  • Inability to comply with study procedures

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intranasal Corticosteroid Monotherapy
Participants received mometasone furoate intranasal spray (100 mcg once daily) for 4 weeks.
Medicin: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg
Mometasone furoate intranasal spray administered once daily for 4 weeks.
Eksperimentel: Bridge Therapy (INS + Oxymetazoline)
Participants received mometasone furoate intranasal spray for 4 weeks combined with oxymetazoline nasal spray during the first 5 days of treatment.
Medicin: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg
Mometasone furoate intranasal spray administered once daily for 4 weeks.
Medicin: Oxymetazoline 0.05% nasal solution
Oxymetazoline nasal spray administered twice daily for 5 days in addition to intranasal corticosteroid therapy.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Total Nasal Symptom Score (TNSS)
Tidsramme: Baseline and Week 4
Evaluation of the change in Total Nasal Symptom Score (TNSS) from baseline to Week 4 between treatment groups.
Baseline and Week 4

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Peak Nasal Inspiratory Flow (PNIF)
Tidsramme: Baseline and Week 4
Change in objective nasal airflow measured by PNIF from baseline to Week 4.
Baseline and Week 4

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)
Tidsramme: Baseline and Week 4
Evaluation of change in disease-specific quality of life scores.
Baseline and Week 4
Change in Nasal Nitric Oxide Levels (nNO)
Tidsramme: Baseline and Week 4
Evaluation of change in nasal nitric oxide levels as a biomarker of nasal inflammation.
Baseline and Week 4
Medication Adherence Rating Scale (MARS)
Tidsramme: Week 4
Assessment of medication adherence using the Medication Adherence Rating Scale.
Week 4

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dr. Behcet Uz Children's Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. januar 2025

Primær færdiggørelse (Faktiske)

15. januar 2026

Studieafslutning (Faktiske)

16. januar 2026

Datoer for studieregistrering

Først indsendt

12. maj 2026

Først indsendt, der opfyldte QC-kriterier

12. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GOA-135

Plan for individuelle deltagerdata (IPD)

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INGEN

IPD-planbeskrivelse

Individual participant data (IPD) will not be publicly shared due to institutional policies and protection of participant confidentiality.

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