The Effect of Single Dose Paracetamol on the Lower Airways of Asthmatic and Healthy Children
The Effect of Paracetamol on Lower Airway Obstruction in Asthmatic Versus Non Asthmatic Children
Asthma is a common inflammatory airway disease. Several researches have demonstrated a possible connection between asthma and exposure to paracetamol.
Our hypothesis is that even a single dose of paracetamol is sufficient to cause a measurable change in lung functions.
This trial aims to identify a possible effect of single dose paracetamol on lower airway function.
調査の概要
詳細な説明
Asthma is a common inflammatory airway disease and its prevalence is on the rise all around the world, Most significantly in children under 5 years.
Paracetamol is one of the most common drugs used with children at thus age groups and several studies have proved a causative connection between exposure to paracetamol and asthma prevalence as well as other allergic conditions.
The mechanism is presumably by reduction of glutathione level, resulting in oxidative burst and formation of reactive oxygen species (ROS).
In addition, paracetamol maybe directly cytotoxic to pneumocytes if given in overdose.
The goal of this research is to identify and quantify the effect of single dose of paracetamol on lung functions of asthmatic and healthy subjects.
The study group will include 40 children aged 7-16 years, who are known to have asthma and a control group of 20 healthy children.
The children will be randomized to receive a dose of paracetamol or placebo, and lung functions will be measured by both spirometry and Fraction of expired Nitric Oxide (FeNO) test.
Each child will receive both paracetamol and placebo, randomly in to consecutive tests, thus children will serve as their own control.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Tel Aviv、イスラエル
- 募集
- Tel Aviv Sourasky Medical Center
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副調査官：
- Assaf Tsivion, M.D
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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:
- age: 7-16 years
- research group: children who have been diagnosed as asthmatic according to the American thoracic society (ATS) criteria
- control group: children who are not known to have asthma
Exclusion Criteria:
- paracetamol sensitivity
- children with any kind of chronic disease (except asthma)
- children with non asthma related chronic lung disease
- acute asthma attack
- children on systemic steroids
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：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：トリプル
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：asthmatic subjects
Asthmatic children will be randomly exposed to paracetamol and placebo consecutively and their lung functions will be blindly compared.
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single dose of paracetamol 15mg/kg.
他の名前：
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他の：Healthy children
Children with no asthma as control group.
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single dose of paracetamol 15mg/kg.
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 |
時間枠 |
|---|---|
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A measurable change in lung functions in response to paracetamol exposure.
時間枠：1 year
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1 year
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協力者と研究者
捜査官
- 主任研究者：Ruth Soferman, M.D、TASMC
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。