Effect of Addition of Single Dose of Oral Montelukast to Standard Treatment in Acute Asthma in Preschool Children.
Phase 4 Study of Single Dose of Oral Montelukast When Adding to Standard Treatment in Acute Moderate to Severe Wheezing in Preschool Children.
調査の概要
詳細な説明
Systemic corticosteroids and short acting beta-2 agonists are the mainstay treatment of acute asthma, however, little data exists regarding use of leukotriene antagonists in acute asthma. A few studies in adults have shown that oral montelukast also improved pulmonary function when being added to the standard treatment. But in school-age children this clinical benefit could not be demonstrated by adding montelukast to the standard treatment of acute asthma in emergency room. Moreover in preschool children there are no studies on this topic.
The investigators hypothesized that addition of single dose of oral montelukast to standard therapy in acute moderate to severe wheezing may provide additional benefit in the meaning of improvement of pulmonary score and/or proportion of discharge from emergency department in preschool-age children.
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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Keçiören
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Ankara、Keçiören、七面鳥、06290
- Kecioren Education and Training Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- 6 months to 6 years of age
- With at least three episodes of wheezing in the previous 12 months
- Who presented to the ED with a moderate to severe wheezing episode (defined as a Pulmonary Index Score [PIS] of 7 to 13
Exclusion Criteria:
- Patients who were receiving more than 400 mcg of inhaled budesonide or equivalent per day
- Who had any change in their dose of ICSs in the past 2 months
- Who had taken systemic corticosteroid within 1 months
- Patients who have concurrent pneumonia, croup or suspected foreign body aspiration, a history of cystic fibrosis, bronchopulmonary dysplasia, bronchiolitis obliterans, congenital heart disease, liver or renal disease,sickle cell anemia or immune deficiency were excluded.
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：4倍
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：1-Montelukast
Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.
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Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.
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プラセボコンパレーター：2- Placebo
Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.
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Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.
他の名前：
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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 |
|---|---|---|
|
Difference of pulmonary index score from baseline to 120 minutes.
時間枠：0 to 120 minutes
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İmprovment of pulmonary index score from 0 to 120 minutes was compared bwtween the montelukast and placebo groups.
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0 to 120 minutes
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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 |
|---|---|---|
|
Proportion of discharge from emergency department.
時間枠：120, 180 and 240. minutes
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Proportion of subjects who were discharged from emergency department at 120,180 and 240.
minutes were compared between the montelukast and placebo groups.
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120, 180 and 240. minutes
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協力者と研究者
捜査官
- スタディディレクター：CEM H RAZİ, M.D.、Kecioren Education and Training Hospital
- 主任研究者：ELİF YAĞLI ÇOLAKOĞLU, M.D.、Kecioren Education and Training Hospital
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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