Treatment of Persistent Wheezing in Infants and Children
Respiratory Function in Infants With Persistent Wheezing
調査の概要
詳細な説明
Asthma prevalence has steadily increased in the United States since the early 1980s, with infants and young children showing the largest increase. Some young children experience wheezing, but it is not known if this is related specifically to asthma. Wheezing may be caused by a respiratory syncytial virus, maternal smoking, a family history of asthma, or allergies. In addition, some infants who experience wheezing may have small or dysfunctional airways and may not respond well to commonly prescribed anti-inflammatory medications. Because of the many causes of wheezing, in order to prescribe the most effective treatment, it is necessary to thoroughly assess lung function, allergic sensitization, and airway inflammation. The purpose of this study is to examine the causes of moderate to severe wheezing in infants and assess the infants' response to inhaled corticosteroid therapy. The study will also assess new and safer ways to measure lung function and airway inflammation.
This study will enroll infants with moderate to severe persistent wheezing. At study entry, participants will undergo lung function testing, which will include a spirometry test, measures of lung volumes, and assessment of bronchodilator responsiveness. Exhaled breath condensate and blood will be collected, and skin-prick testing will be performed to test for allergies. Participants will then be randomly assigned to receive either fluticasone, an inhaled steroid, or placebo for one month. At the end of the month, lung function testing will be performed and exhaled breath and serum measures will be collected to assess airway inflammation. Participants will attend a follow-up evaluation at age 5 years. During the evaluation, lung function, exhaled breath condensate, and serum markers of inflammation will be measured again, and skin-prick testing will also be performed again.
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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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan
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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:
- Moderate to severe persistent wheezing, as defined by the National Asthma Education and Prevention Program Expert Panel Report 2
- No signs of upper or lower respiratory tract infection for at least two weeks prior to study entry
Exclusion Criteria:
- Received therapy with inhaled corticosteroids in the month prior to study entry
- History of seizures or other neurologic disorders
- Hypoxemia requiring supplemental oxygen to maintain oxygen saturation above 90%
- Sepsis
- Underwent a tracheostomy
- Heart disease
- Suspected or documented pulmonary hypertension
- Currently undergoing assisted ventilation
- Born at less than 36 weeks gestation
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:診断
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
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 |
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Change in FEF75 levels
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Change in RV/TLC ratio
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Loss of bronchodilator responsiveness (measured at the end of the one month treatment period and follow-up evaluation when participant is 5 years of age)
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二次結果の測定
結果測定 |
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Change in asthma symptom scores (measured at the end of the one month treatment period and follow-up evaluation when participant is 5 years of age)
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協力者と研究者
捜査官
- 主任研究者:Amy G. Filbrun, MD、University of Michigan
研究記録日
主要日程の研究
研究開始
一次修了
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
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。