Oxymetazoline Bridge Therapy With Intranasal Corticosteroids in Pediatric Allergic Rhinitis

May 12, 2026 updated by: Necmi Can Yüksel, MD, Dr. Behcet Uz Children's Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Izmir, Turkey (Türkiye), 35180
        • Dr. Behcet Uz Pediatric Diseases and Surgery Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intranasal Corticosteroid Monotherapy
Participants received mometasone furoate intranasal spray (100 mcg once daily) for 4 weeks.
Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg
Mometasone furoate intranasal spray administered once daily for 4 weeks.
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.
Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg
Mometasone furoate intranasal spray administered once daily for 4 weeks.
Drug: Oxymetazoline 0.05% nasal solution
Oxymetazoline nasal spray administered twice daily for 5 days in addition to intranasal corticosteroid therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total Nasal Symptom Score (TNSS)
Time Frame: Baseline and Week 4
Evaluation of the change in Total Nasal Symptom Score (TNSS) from baseline to Week 4 between treatment groups.
Baseline and Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Peak Nasal Inspiratory Flow (PNIF)
Time Frame: Baseline and Week 4
Change in objective nasal airflow measured by PNIF from baseline to Week 4.
Baseline and Week 4

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)
Time Frame: Baseline and Week 4
Evaluation of change in disease-specific quality of life scores.
Baseline and Week 4
Change in Nasal Nitric Oxide Levels (nNO)
Time Frame: Baseline and Week 4
Evaluation of change in nasal nitric oxide levels as a biomarker of nasal inflammation.
Baseline and Week 4
Medication Adherence Rating Scale (MARS)
Time Frame: Week 4
Assessment of medication adherence using the Medication Adherence Rating Scale.
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Behcet Uz Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2025

Primary Completion (Actual)

January 15, 2026

Study Completion (Actual)

January 16, 2026

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 12, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOA-135

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be publicly shared due to institutional policies and protection of participant confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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