Oxymetazoline Bridge Therapy With Intranasal Corticosteroids in Pediatric Allergic Rhinitis
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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:
- Intranasal corticosteroid monotherapy group (mometasone furoate for 4 weeks)
- 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.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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Izmir, Turquie (Türkiye), 35180
- Dr. Behcet Uz Pediatric Diseases and Surgery Training and Research Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intranasal Corticosteroid Monotherapy
Participants received mometasone furoate intranasal spray (100 mcg once daily) for 4 weeks.
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Mometasone furoate intranasal spray administered once daily for 4 weeks.
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Expérimental: 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.
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Mometasone furoate intranasal spray administered once daily for 4 weeks.
Oxymetazoline nasal spray administered twice daily for 5 days in addition to intranasal corticosteroid therapy.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Total Nasal Symptom Score (TNSS)
Délai: Baseline and Week 4
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Evaluation of the change in Total Nasal Symptom Score (TNSS) from baseline to Week 4 between treatment groups.
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Baseline and Week 4
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Peak Nasal Inspiratory Flow (PNIF)
Délai: Baseline and Week 4
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Change in objective nasal airflow measured by PNIF from baseline to Week 4.
|
Baseline and Week 4
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)
Délai: Baseline and Week 4
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Evaluation of change in disease-specific quality of life scores.
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Baseline and Week 4
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Change in Nasal Nitric Oxide Levels (nNO)
Délai: Baseline and Week 4
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Evaluation of change in nasal nitric oxide levels as a biomarker of nasal inflammation.
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Baseline and Week 4
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Medication Adherence Rating Scale (MARS)
Délai: Week 4
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Assessment of medication adherence using the Medication Adherence Rating Scale.
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Week 4
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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système immunitaire
- Maladies des voies respiratoires
- Troubles respiratoires
- Hypersensibilité respiratoire
- Hypersensibilité immédiate
- Hypersensibilité
- Maladies du nez
- Maladies oto-rhino-laryngologiques
- Insuffisance respiratoire
- Rhinite
- Obstruction des voies respiratoires
- Comportement
- Adhésion et conformité au traitement
- Comportement de santé
- L'observance du patient
- Acceptation des soins de santé par le patient
- Rhinite allergique
- Obstruction nasale
- Adhésion aux médicaments
- Composés hétérocycliques, 1 anneau
- Composés hétérocycliques
- Azoles
- Composés polycycliques
- Imidazoles
- Équipement et fournitures
- Prégnades
- Grossesse
- Stéroïdes
- Composés à anneau fusionné
- Grossissements
- Nébuleurs et vaporisateurs
- Furoate de mométasone
- Oxymétazoline
- Inhalateurs doseurs
Autres numéros d'identification d'étude
- GOA-135
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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