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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07593898
Enrollment
76
Registered
2026-05-18
Start date
2025-01-02
Completion date
2026-01-16
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Detailed description

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.

Interventions

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.

Sponsors

Dr. Behcet Uz Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Blinding was not feasible because the immediate vasoconstrictive effect of oxymetazoline is clinically perceptible.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Change in Peak Nasal Inspiratory Flow (PNIF)Baseline and Week 4Change in objective nasal airflow measured by PNIF from baseline to Week 4.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026