Study of MAP0010 in Asthmatic Children and Adolescents
A Randomized, Double Blind, Placebo Controlled, 3 Arm, Parallel Group, Phase 2 Study Investigating the Efficacy, Tolerability and Pharmacokinetics of MAP0010 in Asthmatic Children and Adolescents Over 6 Weeks
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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California
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San Diego、California、アメリカ
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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:
- Male or female asthmatic children/adolescents
- 1 to 18 years of age
- FEV1 greater than or equal to 50% predicted normal (where obtainable)
- Stable but symptomatic
- Diagnosis of asthma (per NIH criteria) at least 3 months before screening OR documented exacerbation or worsening of asthma or symptoms suggestive of asthma including nocturnal asthma, within 6 months of screening OR documented SAB use more than or at least once for symptom relief during the 4 days of run in with a total symptom score greater than or equal to 1 OR greater than or equal to 1 night disturbed due to asthma symptoms in previous month.
Exclusion Criteria:
- Any other significant childhood illness.
- Participated in any investigational clinical trial within the 30 days prior to screening.
- Use of any corticosteroid within 2 weeks of screening.
- Use of oral corticosteroid within 30 days of screening or prolonged use of oral corticosteroids within 12 weeks of screening.
- Use of inhaled long acting bronchodilators.
- Presumptive or documented history of upper or lower respiratory infection within 2 weeks before screening.
- Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
- History suggestive (or diagnosis) of other concomitant lung disease.
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：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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実験的：MAP0010 low dose
a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
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a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
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実験的：MAP0010 high dose
a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
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a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
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プラセボコンパレーター：Placebo
Placebo delivered by nebulization twice daily for 6 weeks
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Placebo delivered by nebulization twice daily for 6 weeks
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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 From Baseline in Daytime Composite Symptom Score
時間枠：baseline, week 6
|
The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Daily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 5 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms. |
baseline, week 6
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Change From Baseline in Nighttime Composite Symptom Score
時間枠：baseline, week 6
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The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Nightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 5 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms. |
baseline, week 6
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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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Change From Baseline in FEV1% Predicted
時間枠：baseline, week 6
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The forced expiratory volume in 1 second (FEV1) is the amount forced of air exhaled in 1 second.
The percent predicted is calculated for age, gender, and height.
Subjects had to perform at least 3 acceptable maneuvers into a spirometer.
An increase indicates an improvement (a greater volume of air expired).
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baseline, week 6
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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Medical Director、MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
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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