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NCT Number: NCT07593898

Oxymetazoline Bridge Therapy With Intranasal Corticosteroids in Pediatric Allergic Rhinitis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Mometasone furoate intranasal spray administered once daily for 4 weeks.

Oxymetazoline 0.05% nasal solution

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. Medication Adherence Rating Scale (MARS)

    Time frame: Week 4

    Assessment of medication adherence using the Medication Adherence Rating Scale.

Sponsors and collaborators

Lead sponsor

Dr. Behcet Uz Children's Hospital

Other

Registry information

Official study title

Short-Term Nasal Decongestant as Bridge Therapy Combined With Intranasal Corticosteroids in Children With Persistent Allergic Rhinitis: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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