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
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Izmir、トルコ（Türkiye）、35180
- Dr. Behcet Uz Pediatric Diseases and Surgery Training and Research Hospital
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Intranasal Corticosteroid Monotherapy
Participants received mometasone furoate intranasal spray (100 mcg once daily) for 4 weeks.
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Mometasone furoate intranasal spray administered once daily for 4 weeks.
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実験的：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Total Nasal Symptom Score (TNSS)
時間枠：Baseline and Week 4
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Evaluation of the change in Total Nasal Symptom Score (TNSS) from baseline to Week 4 between treatment groups.
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Baseline and Week 4
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Peak Nasal Inspiratory Flow (PNIF)
時間枠：Baseline and Week 4
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Change in objective nasal airflow measured by PNIF from baseline to Week 4.
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Baseline and Week 4
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)
時間枠：Baseline and Week 4
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Evaluation of change in disease-specific quality of life scores.
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Baseline and Week 4
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Change in Nasal Nitric Oxide Levels (nNO)
時間枠：Baseline and Week 4
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Evaluation of change in nasal nitric oxide levels as a biomarker of nasal inflammation.
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Baseline and Week 4
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Medication Adherence Rating Scale (MARS)
時間枠：Week 4
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Assessment of medication adherence using the Medication Adherence Rating Scale.
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Week 4
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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- GOA-135
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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