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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Izmir, Turquía (Türkiye), 35180
- Dr. Behcet Uz Pediatric Diseases and Surgery Training and Research Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Total Nasal Symptom Score (TNSS)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Peak Nasal Inspiratory Flow (PNIF)
Periodo de tiempo: Baseline and Week 4
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Change in objective nasal airflow measured by PNIF from baseline to Week 4.
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Baseline and Week 4
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema inmunológico
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Hipersensibilidad Respiratoria
- Hipersensibilidad, Inmediata
- Hipersensibilidad
- Enfermedades de la nariz
- Enfermedades Otorrinolaringológicas
- Insuficiencia respiratoria
- Rinitis
- Obstrucción de la vía aerea
- Comportamiento
- Adherencia y Cumplimiento del Tratamiento
- Comportamiento de salud
- Cumplimiento del paciente
- Aceptación del paciente de la atención médica
- Rinitis Alérgica
- Obstrucción nasal
- Adherencia a la medicación
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Azoles
- Compuestos policíclicos
- Imidazoles
- Equipos y suministros
- Espierra
- Embarazos
- Esteroides
- Compuestos de anillo fusionado
- Madreadiediols
- Nebulizadores y vaporizadores
- Furoato de mometasona
- Oximetazolina
- Inhaladores de dosis medida
Otros números de identificación del estudio
- GOA-135
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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