Oxymetazoline Bridge Therapy With Intranasal Corticosteroids in Pediatric Allergic Rhinitis

NCT07593898 | Completed Phase 4 DMC

• 1 other identifier: GOA-135
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Persistent Allergic Rhinitis

Keywords

Allergic Rhinitis; Persistent Allergic Rhinitis; Children; Pediatric; Intranasal Corticosteroids; Oxymetazoline; Medication Adherence; PNIF; Nasal Nitric Oxide; Mometasone Furoate; Nasal Congestion; Bridge Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in Peak Nasal Inspiratory Flow (PNIF)

  Baseline and Week 4

Other Outcomes (3)

• Change in Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)

  Baseline and Week 4

• Change in Nasal Nitric Oxide Levels (nNO)

  Baseline and Week 4

• Medication Adherence Rating Scale (MARS)

  Week 4

Study Arms (2)

Intranasal Corticosteroid Monotherapy

EXPERIMENTAL

Participants received mometasone furoate intranasal spray (100 mcg once daily) for 4 weeks.

Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg

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.

Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg; Drug: Oxymetazoline 0.05% nasal solution

Interventions

Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg DRUG

Mometasone furoate intranasal spray administered once daily for 4 weeks.

Bridge Therapy (INS + Oxymetazoline); Intranasal Corticosteroid Monotherapy

Oxymetazoline 0.05% nasal solution DRUG

Oxymetazoline nasal spray administered twice daily for 5 days in addition to intranasal corticosteroid therapy.

Bridge Therapy (INS + Oxymetazoline)

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital: lead

Study Sites (1)

Dr. Behcet Uz Pediatric Diseases and Surgery Training and Research Hospital

Izmir, 35180, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 40675325 BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic; Medication Adherence; Nasal Obstruction

Interventions

Mometasone Furoate; Metered Dose Inhalers; Oxymetazoline

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Nebulizers and Vaporizers; Equipment and Supplies; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding was not feasible because the immediate vasoconstrictive effect of oxymetazoline is clinically perceptible.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist physician

Model Details: 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.

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 18, 2026
• Study Start: January 2, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 16, 2026
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)