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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Corticosteroid Monotherapy | Experimental | Participants received mometasone furoate intranasal spray (100 mcg once daily) for 4 weeks. |
|
| Bridge Therapy (INS + Oxymetazoline) | Experimental | Participants received mometasone furoate intranasal spray for 4 weeks combined with oxymetazoline nasal spray during the first 5 days of treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg | Drug | Mometasone furoate intranasal spray administered once daily for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Nasal Symptom Score (TNSS) | Evaluation of the change in Total Nasal Symptom Score (TNSS) from baseline to Week 4 between treatment groups. | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Peak Nasal Inspiratory Flow (PNIF) | Change in objective nasal airflow measured by PNIF from baseline to Week 4. | Baseline and Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) | Evaluation of change in disease-specific quality of life scores. | Baseline and Week 4 |
| Change in Nasal Nitric Oxide Levels (nNO) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Behcet Uz Pediatric Diseases and Surgery Training and Research Hospital | Izmir | 35180 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40675325 | Background | Gil-Mata S, Vieira RJ, Borowiack E, Sadowska E, Bognanni A, Cardoso-Fernandes A, Ferreira-Cardoso H, Castro-Teles J, Soprani J, Pinheiro L, Marques-Cruz M, Campos-Lopes M, Lourenco-Silva N, Ferreira-da-Silva R, Bedbrook A, Litynska J, Cherrez-Ojeda I, Klimek L, Pfaar O, Fernandes RM, Fiocchi AG, Giovannini M, Larenas-Linnemann DE, Pham-Thi N, Papadopoulos NG, Roberts G, Valiulis A, Yepes-Nunez JJ, Zuberbier T, Fonseca JA, Schunemann HJ, Bousquet J, Sousa-Pinto B; ARIA 2024 Guideline Panel. Intranasal Treatments for Allergic Rhinitis in Preschool- and School-Age Children: Network Meta-Analysis. J Allergy Clin Immunol Pract. 2025 Oct;13(10):2826-2837. doi: 10.1016/j.jaip.2025.07.004. Epub 2025 Jul 15. |
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Individual participant data (IPD) will not be publicly shared due to institutional policies and protection of participant confidentiality.
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D055118 | Medication Adherence |
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| D036501 | Metered Dose Inhalers |
| D010109 | Oxymetazoline |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Participants were randomized into two parallel treatment groups. One group received intranasal corticosteroid monotherapy, while the second group received intranasal corticosteroid therapy combined with short-term oxymetazoline during the first 5 days of treatment.
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Blinding was not feasible because the immediate vasoconstrictive effect of oxymetazoline is clinically perceptible.
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| Oxymetazoline 0.05% nasal solution | Drug | Oxymetazoline nasal spray administered twice daily for 5 days in addition to intranasal corticosteroid therapy. |
|
Evaluation of change in nasal nitric oxide levels as a biomarker of nasal inflammation.
| Baseline and Week 4 |
| Medication Adherence Rating Scale (MARS) | Assessment of medication adherence using the Medication Adherence Rating Scale. | Week 4 |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D009330 | Nebulizers and Vaporizers |
| D004864 | Equipment and Supplies |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |