A Comparative Study on the Efficacy of Different Stepping-down Therapy for Childhood Asthma
2021年6月29日 更新者：Xijing Hospital
This study is a 24-week, randomized, parallel group comparative effectiveness study to evaluate the risk of stepping down therapy for patients with well-controlled asthma treated with combination Inhaled corticosteroids (ICS) and Leukotriene receptor antagonist（LTRA).
調査の概要
詳細な説明
Asthma guidelines recommend stepping down therapy once asthma is controlled for at least 3 months.
Leukotriene receptor antagonist（LTRA).
For children with mild persistent asthma, ICS twice a day combined with LTRA can be used for treatment, but there is no consensus on how to reduce drugs in patients with asthma that is well controlled (reducing the dose of ICS or stopping montelukast).
We propose a 24-week, randomized, parallel group comparative effectiveness study comparing three approaches in patients with asthma well-controlled for at least three months on combination ICS and LTRA: Halve the dose of ICS firstly and then stop ICS with montelukast only, stop montelukast firstly and then halve the dose of ICS, and halve the dose of ICS firstly and then stop montelukast.
Our goal is to compare the rate of treatment failure and determine the optimal treatment strategy.
Additional goals include assessing risk factors for step-down failure.
研究の種類
介入
入学 (予想される)
90
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Shanxi
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Xi'an、Shanxi、中国、710032
- Department of Pediatrics, Xijing Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
4年～14年 (子)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- age 4-14 years
- patients had mild to moderate persistent asthma. Patients have treated with low-dose inhaled corticosteroids (equivalent to Fluticasone propionate inhaled aerosol 250 ug/ day) combined with Leukotriene receptor antagonist (Montelulast) at least 6 months of and had no symptoms of asthma for nearly 3 months under well asthma control(Asthma Control Test (ACT) score more than or equal to 20).
- patients did not suffer from other acute or chronic diseases that may affect their growth and development
Exclusion Criteria:
- patients with severe persistent asthma or mild persistent asthma failed to be well controlled by low-dose ICS after starting treatment
- suffer from other diseases: Congenital heart disease, chronic infectious disease, protracted diarrhea, congenital airway disease, congenital vascular ring malformation, congenital immune deficiency, tracheal foreign body, bronchial lymph node tuberculosis and gastroesophageal reflux etc.
- patients with poor compliance stop medication or fail to take medication on time.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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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アクティブコンパレータ：Stop Fluticasone propionate Inhaled Aerosol Firstly
Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped Fluticasone propionate Inhaled Aerosol and continuation of montelukast once a day
|
The study consists of two stages and include three groups.
Three groups include: Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped Fluticasone propionate Inhaled Aerosol and continuation of montelukast once a day; Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug once a day; Stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug twice daily, and then Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day.
The scheme of every group is divided into two stages.
Only those whose asthma are well controlled at the end of the first phase will be allowed to proceed to the next phase.
|
|
アクティブコンパレータ：Stop Montelukast Secondly
Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug once a day
|
The study consists of two stages and include three groups.
Three groups include: Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped Fluticasone propionate Inhaled Aerosol and continuation of montelukast once a day; Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug once a day; Stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug twice daily, and then Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day.
The scheme of every group is divided into two stages.
Only those whose asthma are well controlled at the end of the first phase will be allowed to proceed to the next phase.
|
|
アクティブコンパレータ：Stop Montelukast Firstly
stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug twice daily, and then Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day
|
The study consists of two stages and include three groups.
Three groups include: Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped Fluticasone propionate Inhaled Aerosol and continuation of montelukast once a day; Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug once a day; Stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug twice daily, and then Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day.
The scheme of every group is divided into two stages.
Only those whose asthma are well controlled at the end of the first phase will be allowed to proceed to the next phase.
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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 |
|---|---|---|
|
Asthma Control Test (ACT) score
時間枠：Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
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Change in participant's Asthma Control Test (ACT) score
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Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
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Number of Participants Who Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
時間枠：Baseline (Week 0) to Week 12
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Participants Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
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Baseline (Week 0) to Week 12
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Number of Participants Who Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
時間枠：Baseline (Week 0) to Week 24
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Participants Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
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Baseline (Week 0) to Week 24
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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 |
|---|---|---|
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Fractional exhaled Nitric Oxide, FeNO
時間枠：Baseline, 12 weeks and 24 weeks
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Change in participant's Fractional exhaled Nitric Oxide
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Baseline, 12 weeks and 24 weeks
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Forced expiratory volume in one second in predicted（FEV1%pred）
時間枠：Baseline, 12 weeks and 24 weeks
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Change in participant's Forced expiratory volume in one second in predicted
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Baseline, 12 weeks and 24 weeks
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Forced vital capacity in predicted(FVC%pred)
時間枠：Baseline, 12 weeks and 24 weeks
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Change in participant's Forced vital capacity in predicted
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Baseline, 12 weeks and 24 weeks
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Maximal mid expiratory flow in predicted(MMEF%pred)
時間枠：Baseline, 12 weeks and 24 weeks
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Change in participant's Maximal mid expiratory flow in predicted
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Baseline, 12 weeks and 24 weeks
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Peak expiratory flow (PEF)
時間枠：Baseline, 12 weeks and 24 weeks
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Change in participant's Peak expiratory flow
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Baseline, 12 weeks and 24 weeks
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2021年8月1日
一次修了 (予想される)
2022年8月1日
研究の完了 (予想される)
2022年8月1日
試験登録日
最初に提出
2021年6月11日
QC基準を満たした最初の提出物
2021年6月29日
最初の投稿 (実際)
2021年7月8日
学習記録の更新
投稿された最後の更新 (実際)
2021年7月8日
QC基準を満たした最後の更新が送信されました
2021年6月29日
最終確認日
2020年9月1日
詳しくは
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