Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma
2015年1月15日 更新者：Novartis Pharmaceuticals
A Multicenter, Randomized, Double-blind, Placebo-controlled, 12-week Treatment, Parallel-group Study to Assess the Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate (75 and 150 µg o.d.) in Patients With Persistent Asthma
To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.
調査の概要
研究の種類
介入
入学 (実際)
335
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Rotterdam、オランダ、3045 PM
- Novartis Investigative Site
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Sittard-Geleen、オランダ、6162 BG
- Novartis Investigative Site
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Ontario
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Brampton、Ontario、カナダ、L6T 0G1
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Downsview、Ontario、カナダ、M3N 2Z9
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Etobicoke、Ontario、カナダ、M9V 4B4
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Grimsby、Ontario、カナダ、L3M 1P3
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Hamilton、Ontario、カナダ、L8N 3Z5
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Newmarket、Ontario、カナダ、L3Y 5G8
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Toronto、Ontario、カナダ、M5T 3A9
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Woodstock、Ontario、カナダ、N4S 5P5
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Quebec
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Montreal、Quebec、カナダ、H4J 1C5
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Pointe-Claire、Quebec、カナダ、H9R 4S3
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St-Romuald、Quebec、カナダ、G6W 5M6
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Ste-Foy、Quebec、カナダ、G1W 4R4
- Novartis Investigative Site
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Dunajska Streda、スロバキア、929 01
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Komarno、スロバキア、945 01
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Kosice、スロバキア、040 01
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Liptovsky Hradok、スロバキア、033 01
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Liptovsky Mikulas、スロバキア、031 23
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Nove Zamky、スロバキア、940 01
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Rimavska Sobota、スロバキア、979 01
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Spisská Nová Ves、スロバキア、052 01
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Topolcany、スロバキア、955 01
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Vysne Hagy、スロバキア、5984
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Zvolen、スロバキア、960 01
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Slovak Republic
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Banska Bystrica、Slovak Republic、スロバキア、975 17
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Bardejov、Slovak Republic、スロバキア、085 01
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Slovak republic
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Levice、Slovak republic、スロバキア、934 01
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Bad Woerishofen、ドイツ、86825
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Bonn、ドイツ、53123
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Dortmund、ドイツ、44263
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Dresden、ドイツ、01307
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Frankfurt、ドイツ、60596
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Lübeck、ドイツ、23552
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Mainz、ドイツ、55131
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Muenchen、ドイツ、81677
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Wiesbaden、ドイツ、65187
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Wiesloch、ドイツ、69168
- Novartis Investigative Site
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Lovech、ブルガリア、5500
- Novartis Investigative Site
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Pleven、ブルガリア、5800
- Novartis Investigative Site
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Plovdiv、ブルガリア、4002
- Novartis Investigative Site
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Ruse、ブルガリア、7002
- Novartis Investigative Site
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Sofia、ブルガリア、1431
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Sofia、ブルガリア、1233
- Novartis Investigative Site
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Sofia、ブルガリア、1606
- Novartis Investigative Site
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Sofia、ブルガリア、1612
- Novartis Investigative Site
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Sofia、ブルガリア、1000
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Sofia、ブルガリア、1234
- Novartis Investigative Site
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Sofia、ブルガリア、1463
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Varna、ブルガリア、9000
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Varna、ブルガリア、9020
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Veliko Tarnovo、ブルガリア、5000
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Bialystok、ポーランド、15-461
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Bienkowka、ポーランド、34-212
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Bydgoszcz、ポーランド、85-046
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Gdansk、ポーランド、80-958
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Krakow、ポーランド、31-023
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Lodz、ポーランド、90-302
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Lodz、ポーランド、90-242
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Lublin、ポーランド、20-637
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Lublin、ポーランド、20-044
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Torun、ポーランド、87-100
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Wroclaw、ポーランド、50-088
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Znin、ポーランド、88-400
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Seoul、大韓民国、120-752
- Novartis Investigative Site
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Seoul、大韓民国、158-710
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Seoul、大韓民国、152-703
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Seoul、大韓民国、100-032
- Novartis Investigative Site
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Chungbuk
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Cheongju、Chungbuk、大韓民国、361 711
- Novartis Investigative Site
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Gangwon-Do
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Wonju、Gangwon-Do、大韓民国、220-701
- Novartis Investigative Site
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Korea
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Seoul、Korea、大韓民国、110 744
- Novartis Investigative Site
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Fukuoka、日本、811-1394
- Novartis Investigative Site
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Gifu、日本、502-8558
- Novartis Investigative Site
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Fukuoka
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Yanagawa、Fukuoka、日本、832-0059
- Novartis Investigative Site
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Hokkaido
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Obihiro、Hokkaido、日本、080-0805
- Novartis Investigative Site
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Sapporo-city、Hokkaido、日本、060-0061
- Novartis Investigative Site
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Hyogo
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Himeji-city、Hyogo、日本、672-8064
- Novartis Investigative Site
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Hyogo-Ken
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Ako-shi、Hyogo-Ken、日本、678-0241
- Novartis Investigative Site
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Ibaraki
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Naka-gun、Ibaraki、日本、319-1113
- Novartis Investigative Site
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Kagawa
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Sakaide、Kagawa、日本、762-0031
- Novartis Investigative Site
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Kyoto-Fu
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Kyoto-shi、Kyoto-Fu、日本、615-8256
- Novartis Investigative Site
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Mie
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Tsu、Mie、日本、514-1101
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Oita
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Beppu、Oita、日本、874-0937
- Novartis Investigative Site
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Oita-Ken
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Oita-shi、Oita-Ken、日本、870-0021
- Novartis Investigative Site
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Osaka
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Kishiwada、Osaka、日本、596-8501
- Novartis Investigative Site
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Tokyo
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Chuo-ku、Tokyo、日本、103-0027
- Novartis Investigative Site
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Cyuo-ku、Tokyo、日本、104-8560
- Novartis Investigative Site
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Itabashi-ku、Tokyo、日本、173-8610
- Novartis Investigative Site
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Kiyose-city、Tokyo、日本、204-8585
- Novartis Investigative Site
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Setagaya-ku、Tokyo、日本、158-0097
- Novartis Investigative Site
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Tokyo-To
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Machida-shi、Tokyo-To、日本、194-0023
- Novartis Investigative Site
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Ota-ku、Tokyo-To、日本、144-0035
- Novartis Investigative Site
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Yamagata
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Yonezawa、Yamagata、日本、992-0045
- Novartis Investigative Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:
- Patients who are receiving ICS treatment in a stable regimen for ≥ 4 weeks
- Patients with a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% of predicted normal value
- Patients who demonstrate an increase of >= 12% and 200 mL in FEV1
- ACQ-5 score ≥ 1.5
Exclusion Criteria:
- Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
- Patients with chronic lung disease, including COPD, pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disease and cystic fibrosis.
- Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.
Other protocol-defined inclusion/exclusion criteria may apply
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ダブル
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：indacaterol acetate 75 µg
indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od |
indacaterol acetate 75 µg or indacaterol acetate 150 µg delivered via Concept 1 inhaler
via Twisthaler inhaler
|
|
実験的：indacaterol acetate 150 µg
indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od |
indacaterol acetate 75 µg or indacaterol acetate 150 µg delivered via Concept 1 inhaler
via Twisthaler inhaler
|
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プラセボコンパレーター：placebo
placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od |
via Twisthaler inhaler
placebo delivered via Concept 1 inhaler
|
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 |
|---|---|---|
|
Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)
時間枠：after 12 weeks (Day 85)
|
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards.
Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 12 weeks (Day 85)
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after 12 weeks (Day 85)
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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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Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)
時間枠：aftert 12 weeks (Day 85)
|
The Asthma Control Questionnaire (ACQ-5) is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze.
The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
A negative change in score indicates improvement in symptoms.
MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error.
Center is included as a random effect nested within region.
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aftert 12 weeks (Day 85)
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Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.
時間枠：Day 15, Day 29 and Day 57
|
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards.
Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 2 weeks (Day 15), 4 weeks (Day 29), and 8 weeks (Day 57) of treatment.
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Day 15, Day 29 and Day 57
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Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points
時間枠：Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
|
Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards.
FVC is measured on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at all time points
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Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
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Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
時間枠：Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
|
Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards.
|
Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
|
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Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
時間枠：Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
|
Forced Expiratory Flow (FEF 25-75%) was measured via spirometry conducted according to internationally accepted standards.
|
Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
|
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Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)
時間枠：Day 1, 2 Weeks, 12 Weeks
|
Forced Expiratory Volume in 1 second (FEV1)/Area Under the Curve(AUC) was measured via spirometry conducted according to internationally accepted standards.FEV1 AUC(5 min - 4 h), (5 min - 1 h) and (1 h - 4 h) are measured at Day 1, 2 Weeks (Day 14) and 12 Weeks (Day84) and defined as average of FEV1 at specified timepoints above.
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Day 1, 2 Weeks, 12 Weeks
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Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)
時間枠：Day 1, 2 weeks (Day 14), 12 weeks (Day 84)
|
Peak Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards.
Peak FEV1 is defined as the maximum FEV1 during the first 4 h post morning dosing at Day 1, 2Weeks and 12 Weeks.
|
Day 1, 2 weeks (Day 14), 12 weeks (Day 84)
|
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Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment
時間枠：after 4 weeks (Day 29) and after 8 weeks (Day 57)
|
The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze.
Each item is graded on a scale of 0-6 and the questions are equally weighted.
The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
|
after 4 weeks (Day 29) and after 8 weeks (Day 57)
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Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.
時間枠：baseline, 4weeks, 8 weeks and 12 weeks
|
PEFR is measured with portable spirometer by participants every morning and evening at home.
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baseline, 4weeks, 8 weeks and 12 weeks
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The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment
時間枠：12 weeks
|
Participants record the number of puffs of rescue medication taken in the previous 12 hours in the morning and nighttime.
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12 weeks
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Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment
時間枠：4 Weeks, 12 Weeks
|
The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma.
Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks.
The overall AQLQ score is the mean response to all 32 questions.
Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1.
Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.
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4 Weeks, 12 Weeks
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Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
時間枠：12 weeks
|
Duration of treatment until first asthma exacerbation by severity of exacerbation.
A severe asthma exacerbation is systemic corticosteroids (SCS) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma.
A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h).
Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
|
12 weeks
|
|
The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
時間枠：12 weeks
|
Annual incidence rate of asthma exacerbation by severity of exacerbation.
The number of asthma exacerbation is used to calculate annual incidence rate.
A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma.
A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h).
Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
Number of the asthma exacerbation will be analyzed by the negative binomial regression including treatment, history of asthma exacerbation in the 12 months prior to screening and region as factors and FEV1 prior to inhalation and FEV1 30 min post inhalation of salbutamol/albuterol (components of SABA reversibility) as covariates.
The estimates are obtained from the model and so we cannot specify a formula.
|
12 weeks
|
|
Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
時間枠：12 weeks
|
Duration of asthma exacerbations by severity of exacerbation.
A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma.
A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h).
Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
|
12 weeks
|
|
The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
時間枠：12 weeks
|
The percentage of patients with at least one asthma exacerbation by severity of exacerbation.
A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma.
A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h).
Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
|
12 weeks
|
|
Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period
時間枠：12 weeks
|
Time to permanent study discontinuation due to asthma exacerbation.
A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma.
A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h).
Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
|
12 weeks
|
|
The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period
時間枠：12 weeks
|
The percentage of patients who permanently discontinued study due to asthma exacerbation.
A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma.
A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h).
Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
|
12 weeks
|
|
Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period
時間枠：12 weeks
|
Total amounts (in doses) of systemic corticosteroids (SCS) used to treat asthma exacerbations.SCS includes Intramuscular (IM), Intravenous (IV) and Oral.
A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma.
A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h).
Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
|
12 weeks
|
|
Plasma Indacaterol Concentrations at Day 1 and Day 14
時間枠：Day 1 and Day 14
|
Maximum plasma concentration after drug administration (Cmax) was measured for indacaterol acetate 75 µg and indacaterol acetate 150 µg for Pharmacokinetic (PK) Subgroup
|
Day 1 and Day 14
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年8月1日
一次修了 (実際)
2013年7月1日
研究の完了 (実際)
2013年7月1日
試験登録日
最初に提出
2012年4月23日
QC基準を満たした最初の提出物
2012年5月29日
最初の投稿 (見積もり)
2012年6月1日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年1月27日
QC基準を満たした最後の更新が送信されました
2015年1月15日
最終確認日
2015年1月1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。