A 12-Week Study in Adult Subjects With Asthma
A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Study to Replicate Efficacy of Nebulized Fluticasone Propionate (FP) in Adult Subjects With Partly Controlled and Uncontrolled Asthma
調査の概要
詳細な説明
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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South Carolina
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Rock Hill、South Carolina、アメリカ、29732
- CU Pharmaceutical Research
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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:
- A signed and dated written informed consent form prior to the conduct of any study procedures
- Males and females between ≥ 18 and ≤ 60 years old.
- Non-smoker for at least 1 year prior to Visit 1, with a smoking history of no more than 10 pack-years (e.g., 1 pack [20 cigarettes] per day for 10 years).
6.Ability to understand and comply with the protocol requirements (including completion of daily PEFR, PFT and ACQ), instructions and protocol-stated restrictions.
7.Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit. WOCBP include: any female who has experienced menarche and is not post-menopausal (defined as amenorrhea for at least 12 consecutive months), or has not undergone surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation). Women who are using acceptable contraceptive medications or devices to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) will be considered WOCBP.
WOCBP must agree to avoid becoming pregnant for the duration of the study by using adequate contraception at study entry and throughout the trial. Examples of adequate contraception include the following:
- Norplant
- Medroxyprogesterone acetate injection
- Oral contraception
- Double-barrier method (e.g., condom and spermicide)
Abstinence, with one of the above WOCBP will be advised to notify the Investigator of any changes in their pregnancy status or any change in contraceptive use.
8.Agreement by subject to abide by the study protocol and its restrictions.
Exclusion Criteria:
- Past or present disease, excluding asthma, which as judged by the investigator, may place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives These diseases include, but are not limited to cardiovascular disease, malignancy, gastrointestinal disease, hepatic disease, diabetes type I or uncontrolled diabetes, type II, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including, but not confined to chronic bronchitis, emphysema, bronchiectasis, COPD, eosinophilic bronchitis or pulmonary fibrosis).
- An upper or lower respiratory tract infection within 4 weeks of Visit 1 and prior to Visit 2
- A history of hypersensitivity to the study drug or its components, including albuterol as rescue medication.
- History of illegal drug or alcohol abuse within the past 5 years.
- Pregnant or lactating women.
- Use of > 8 inhalations per day of SABA on any two consecutive days from screening to randomization (Visits 1 and 2).
- Use of an investigational drug or device within 30 days prior to screening
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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実験的:プロピオン酸フルチカゾン (FP) - アーム 1
FP BID (1 日 2 回)
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FP Inhalation BID
他の名前:
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実験的:プロピオン酸フルチカゾン (FP) - アーム 2
FP入札
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FP Inhalation BID
他の名前:
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実験的:プロピオン酸フルチカゾン (FP) - アーム 3
FP入札
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FP Inhalation BID
他の名前:
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実験的:プロピオン酸フルチカゾン (FP) - アーム 4
FP入札
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FP Inhalation BID
他の名前:
|
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実験的:プロピオン酸フルチカゾン (FP) - アーム 5
FP入札
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FP Inhalation BID
他の名前:
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プラセボコンパレーター:Placebo - Arm 6
Placebo inhalation solution
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FP Inhalation BID
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 |
|---|---|
|
FEV1 (Forced Expiry Volume in 1 second)
時間枠:FEV1 at Week 12
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FEV1 at Week 12
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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ピーク呼気流量 (PEFR)
時間枠:12週目のPEFR
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12週目のPEFR
|
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:Imtiaz Chaudry、Dey
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
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。