慢性閉塞性肺疾患患者における研究 (FUTURE)
Foster® 100/6 (ジプロピオン酸ベクロメタゾン 100 µg プラス フォルモテロール 6 µg/作動) の有効性と安全性を比較する 12 週間、多施設共同、多国籍、無作為化、二重盲検、二重ダミー、2 群並行群間試験、2パフ b.i.d.、Versus Seretide® 500/50 (フルチカゾン 500 µg プラス サルメテロール 50 µg/作動)、1 吸入 b.i.d.、慢性閉塞性肺疾患患者
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 3
連絡先と場所
研究場所
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Belfast、イギリス
- Belfast City Hospital
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London、イギリス
- Kings College Hospital
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Newcastle、イギリス
- Freeman Hospital
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Bologna、イタリア
- Ospedale Sant'Orsola-Malpighi
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Catania、イタリア
- A.O. Policlinico
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Monza、イタリア
- A.O. S. Gerardo
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Naples、イタリア
- Azienda Ospedaliera Monaldi
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Pisa、イタリア
- Universita di Pisa
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Roma、イタリア
- IRCCS San Raffaele La Pisana
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Rome、イタリア、00161
- Policlinico Umberto I - VIII Padiglione
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Barcelona、スペイン
- Hospital Del Mar
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Sabadell、スペイン
- Hospital Parc Tauli
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Vic、スペイン
- Hospital General Vic
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Humenné、スロバキア
- Neštátna ambulancia pneumológie a ftizeológie, Nemocničná
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Nové Zámky、スロバキア
- Diunea, sro. Ambulancia PaF
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Ostrov、スロバキア
- ALERGOIMUNO s.r.o
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Poprad、スロバキア
- Pľúcna ambulancia, Poliklinika ADUS
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Prešov、スロバキア
- PULMO, s.r.o
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Prievidza、スロバキア
- PNEUMO-MED, s.r.o
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Spišská Nová Ves、スロバキア
- Pľúcna ambulancia, Hrebenár s.r.o
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Trnava、スロバキア
- PNEUMO-CENTRUM, s.r.o, Poliklinika
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Aarhus、デンマーク
- Aarhus University Hospital
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Copenhagen、デンマーク
- Bispebjerg Hospital
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Copenhagen、デンマーク
- Dept. of Cardiology and Respiratory Medicine
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Gentofte Municipality、デンマーク
- Gentofte Hospital
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Odense、デンマーク
- Odense University Hospital
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Adana、トルコ（Türkiye）
- Çukurova Üniversitesi
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Antalya、トルコ（Türkiye）
- Akdeniz Universitesi
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Antalya、トルコ（Türkiye）
- Bilim Üniversitesi
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Bornova、トルコ（Türkiye）
- Ege Üniversitesi
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Bursa、トルコ（Türkiye）
- Uludağ Üniversitesi
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Gaziantep、トルコ（Türkiye）
- Gaziantep Üniversitesi
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Istanbul、トルコ（Türkiye）
- Fatih Üniversitesi
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Istanbul、トルコ（Türkiye）
- Marmara Üniversitesi
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Izmir、トルコ（Türkiye）
- Dokuz Eylul Universitesi
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Kayseri、トルコ（Türkiye）
- Erciyes Üniversitesi
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Berlin、ドイツ
- Praxis Dr. Jorg Kampschulte
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Leipzig、ドイツ
- Praxis Dr. Jörg Winkler
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Lübeck、ドイツ
- KLB Healthresearch
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Lübeck、ドイツ
- KLD Helthreseach
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Magdeburg、ドイツ
- SMO.MD GmbH Zentrum für Klinische Studien
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Saarbrücken、ドイツ
- Pneumologische Gemeinschaftspraxis Saarbrücken
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Wedel、ドイツ
- Fachinternistische Gemeinschafts
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Wiesloch、ドイツ
- Pneumologische Praxis Dr Redlich
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Wuppertal、ドイツ
- Gemeinschaftspraxis für Pneumologie
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Balassagyarmat、ハンガリー
- Dr. Kenessey Albert Kórház - Rendelőintézet
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Budapest、ハンガリー
- Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház
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Békés、ハンガリー
- Békés Megyei Képviselő-testület Pándy Kálmán Kórház
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Debrecen、ハンガリー
- Centrum-Tüdőgyógyászati Klinika
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Kecskemét、ハンガリー
- Bács-Kiskun Megeyi Önkormanyzat...
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Mosonmagyaróvár、ハンガリー
- Karolina Kórház és Rendelőintézet Tüdőgyógyászat
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Nyíregyháza、ハンガリー
- Jósa András Hospital
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Nyíregyháza、ハンガリー
- Békés Megyei Képviselő-testület Pándy Kálmán Kórház
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Szigetszentmiklös、ハンガリー
- Chiesi Clinical Centre Szigetszentmiklös
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Toulon、フランス
- Centre Hospitalier
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Gdansk、ポーランド
- NZOZ "Non Nocere"
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Koszalin、ポーランド
- Niepubliczny Zakład Opieki Zdrowotnej "PROFILAKTYKA"
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Krakow、ポーランド
- Szpital Uniwersytecki w Krakowie
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Krakow、ポーランド
- Szpital Specjalistyczny im Jana Pawła II
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Lodz、ポーランド
- Prywatny Gabinet Specjalistyczny
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Szczecin、ポーランド
- Samodzielny Publiczny Szpital Kliniczny
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Warsaw、ポーランド
- Chorób Płuc
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Warsaw、ポーランド
- Gabinet Lekarski SERIA IWONA GRZELEWSKA-RZYMOWSKA
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Warsaw、ポーランド
- Instytut Gruźlicy i Chorób Płuc. Zakład Diagnostyki i Leczenia Niewydolności Oddychania
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Warsaw、ポーランド
- Zakład Fizjopatologii Oddychania, Instytut Gruźlicy i Chorób Płuc
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Wroclaw、ポーランド
- DOBROSTAN - Gabinety Lekarskie
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Wroclaw、ポーランド
- NZOZ Lekarze Specjaliści J.Małolepszy i Partnerzy
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Zgierz、ポーランド
- Wojewódzki Szpital Specjalistyczny im. M. Curie-Skłodowskiej)
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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
説明
包含基準:
- -40歳以上の男性または女性の患者で、研究関連の手続きの開始前にインフォームドコンセントフォームに署名したか、法定代理人によって取得された書面によるインフォームドコンセントが一度適用されます。
COPDと診断された外来患者で、以下を含む：
- [(1 日あたりの喫煙本数) x (喫煙年数) / 20] で定義される 10 パック年以上の喫煙歴、現在および元喫煙者の両方が対象です。
- -過去2か月間の気管支拡張薬の使用 1.
- -気管支拡張薬投与後の FEV1 < 予測正常値の 60%。
- 気管支拡張薬投与後の FEV1/FVC < 0.7。
- 可逆性試験に対する 5% 以上の反応。
- -ベースライン呼吸困難指数（BDI）の焦点スコアが10以下（来院2でも満たされる）。
- -過去12か月（過去2か月を考慮しない）でCOPDの増悪が1回以下の病歴 1。
- pMDI および DPI (Accuhaler®、円形成形プラスチック吸入器) 吸入器を適切に使用するための協力的な態度と訓練を受ける能力。
主な除外基準:
- 臨床的に関連する呼吸器疾患。
- -COPD以外の喘息または呼吸器疾患の現在の診断。
- -研究者の判断による研究結果の実現可能性に影響を与える可能性のある重大または不安定な付随疾患を示す臨床的に重要な検査室および心電図の異常。
- -スクリーニングの2か月前および研究期間中にCOPD増悪を起こした患者。
- -慢性低酸素血症のために長期（毎日少なくとも12時間）の酸素療法を必要とする患者。
- 来院1の2か月前および慣らし期間中にデポコルチコステロイドで治療された患者。
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：Foster®
Participants received 2 puffs of Foster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose) administered via a pMDI twice daily (BID), resulting in a total daily dose of beclomethasone dipropionate 400 μg plus formoterol 24 μg, for a duration of 12 weeks.
To ensure blinding, participants received one inhalation of placebo matching Seretide® Accuhaler® via a inhaler BID, for a duration of 12 weeks.
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Administered via a pressurized metered-dose inhaler
他の名前：
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アクティブコンパレータ：Seretide® Accuhaler®
Participants received one inhalation of Seretide® Accuhaler® (fluticasone 500 μg plus salmeterol 50 μg/actuation) administered via inhaler, BID resulting in a total daily dose of fluticasone 1000 μg plus salmeterol 100 μg, for a duration of 12 weeks.
To ensure blinding, participants receieved two puffs of placebo matching Foster® via pMDI, BID for a duration of 12 weeks.
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Administered via a pressurized metered-dose inhaler
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Area Under the Curve (AUC) 0-30min Standardized by Time of Change From Pre-dose in Forced Expiratory Volume in One Second (FEV1) in the Morning of Day 1
時間枠：on Day 1 (V2)
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.
FEV1 was measured using spirometry, conducted at baseline and all clinical visits.
An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction.
Higher FEV1 values indicate better lung function.
Adjusted means were reported.
Assessment were implemented at pre-dose, and 5, 15 and 30 minutes post inhalation
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on Day 1 (V2)
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Transition Dyspnoea Index (TDI) Score at Day 84
時間枠：Day 84 (V5)
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TDI has three domains as follows:
The TDI score ranges from -3 (major deterioration) to +3 (major improvement) for each domain. The sum of all domains yields the TDI focal score of -9 (major deterioration) to +9 (major improvement). Adjusted means were reported. |
Day 84 (V5)
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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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AUC 0-30min Standardized by Time of Change From Pre-dose in FEV1 in the Morning of Day 84
時間枠：on Day 84 (V5)
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.
FEV1 was measured using spirometry, conducted at baseline and all clinical visits.
An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction.
Higher FEV1 values indicate better lung function.
Adjusted means were reported.
Assessments were implemented pre-dose, 5, 15 and 30 minutes post inhalation.
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on Day 84 (V5)
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AUC 0-30min Standardized by Time of Change From Baseline in FEV1 After Drug Inhalation in the Morning of Day 84
時間枠：on Day 84 (V5)
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.
FEV1 was measured using spirometry, conducted at baseline and all clinical visits.
An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction.
Higher FEV1 values indicate better lung function.
Adjusted means were reported.
Assessments were implemented at baseline and 5,15 and 30 minutes post inhalation.
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on Day 84 (V5)
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Change From Baseline (CFB) in Pre-dose Morning FEV1
時間枠：Weeks 4, 8 and 12
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.
FEV1 was measured using spirometry, conducted at baseline and all clinical visits.
An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction.
Higher FEV1 values indicate better lung function.
Adjusted means were reported.
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Weeks 4, 8 and 12
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Change From Baseline in Pre-dose Morning Forced Vital Capacity (FVC)
時間枠：Weeks 4, 8 and 12
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FVC is is a measure of lung function and is defined as the amount of air that can be forcefully exhaled from lungs after taking the deepest breath possible, FVC was measured using spirometry at baseline and all clinical visits.
Higher values indicate improved lung capacity and reduced airway obstruction.
Adjusted means were reported.
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Weeks 4, 8 and 12
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Change From Pre-dose in Morning FEV1 at 5, 15 and 30 Min After Drug Intake
時間枠：5, 15, 30 Min post inhalation at Weeks 0 (V2) and 12 (Day 84, V5)
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.
FEV1 was measured using spirometry, conducted at baseline and all clinical visits.
An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction.
Higher FEV1 values indicate better lung function.
Adjusted means were reported.
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5, 15, 30 Min post inhalation at Weeks 0 (V2) and 12 (Day 84, V5)
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Change From Baseline in Morning FEV1 at 5, 15 and 30 Min After Drug Intake
時間枠：at 5, 15 and 30 mins post inhalation at Week 12 (Day 84, V5)
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FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.
FEV1 was measured using spirometry, conducted at baseline and all clinical visits.
An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction.
Higher FEV1 values indicate better lung function.
Adjusted means were reported.
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at 5, 15 and 30 mins post inhalation at Week 12 (Day 84, V5)
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Change From Pre-dose in Morning FVC at 5, 15 and 30 Min After Drug Intake
時間枠：at 5, 15 and 30 min post inhalation Week 0 (V2) & Week 12 Day 84, (V5)
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FVC is is a measure of lung function and is defined as the amount of air that can be forcefully exhaled from lungs after taking the deepest breath possible, FVC was measured using spirometry at baseline and all clinical visits.
Higher values indicate improved lung capacity and reduced airway obstruction.
Adjusted means were reported.
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at 5, 15 and 30 min post inhalation Week 0 (V2) & Week 12 Day 84, (V5)
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Change From Baseline to Each Two-Week Period in COPD Symptom Scores
時間枠：Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
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COPD symptom scores consists of following 6 items recorded by the participants in diary.
Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst). Baseline COPD symptom score has been calculated as the mean of the COPD symptom scores recorded in the run-in period. Each item or total scores were averaged over each 2 week period. Average COPD symptom score in each two-week period has been calculated as the mean of the item or total score recorded in each two-week period. Adjusted means were reported. |
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
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Change From Baseline to Each Two-Week Period in Percentage of COPD Symptom-Free Days
時間枠：Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
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COPD symptom scores consists of following 6 items recorded by the participants in diary.
Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst). A COPD symptom-free day is a day with total COPD symptom scores = 0. Baseline % of COPD symptom-free days is calculated as the % ratio between the number of COPD symptom-free days and the number of days with data recorded in the run-in period)*100. Reported values (in form of adjusted means) reflect a percentage (%). % of COPD symptom-free days in each two-week period is calculated as % (ratio between the number of COPD symptom-free days and the number of days with data recorded in the two-week period)*100. |
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
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Change From Baseline to Entire Treatment Period in Percentage of COPD Symptom-Free Days
時間枠：Baseline, Weeks 1 through 12
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COPD symptom scores consists of following 6 items recorded by the participants in diary.
Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst). A COPD symptom-free day is a day with total COPD symptom scores = 0. Reported values (in form of adjusted means) reflect a percentage (%). Baseline % of COPD symptom-free days is calculated as (% ratio between the number of COPD symptom-free days and the number of days with data recorded in the run-in period)*100. % of COPD symptom-free days in each two-week period is calculated as (% ratio between the number of COPD symptom-free days and the number of days with data recorded in the two-week period)*100. |
Baseline, Weeks 1 through 12
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Change From Baseline to Each Two-Week Period in Average Use of Rescue Salbutamol Consumption
時間枠：Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
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Number of rescue salbutamol puffs per day were recorded in the diary.
Baseline use of rescue medication has been calculated as the mean number of puffs per day in the run-in period.
Average use of rescue medication in each two-week period has been calculated as the mean number of puffs per day in each two week period.
Adjusted means were reported.
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Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
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Change From Baseline to Each Two-Week Period in Percentage of Rescue Salbutamol-Free Days
時間枠：Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
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A rescue medication-free day is a day with number of puffs of rescue medication = 0. Reported values (in form of adjusted means) reflect a percentage (%). Baseline percentage (%) of rescue medication-free days is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the run-in period)*100. % of rescue medication-free days in each two-week period is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the two-week period)*100. |
Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12
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Change From Baseline to Entire Treatment Period in Percentage of Rescue Salbutamol-Free Days
時間枠：at week 12 (V5)
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A rescue medication-free day is a day with number of puffs of rescue medication = 0. Reported values (in form of adjusted means) reflect a percentage (%). Baseline % of rescue medication-free days is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the run-in period)*100. % of rescue medication-free days in the entire treatment period is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the entire treatment period)*100. |
at week 12 (V5)
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Change From Baseline in the St George's Respiratory Questionnaire (SGRQ) Component and Total Scores
時間枠：at Week 12 (V5)
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SGRQ is a 76-item questionnaire developed to measure health in chronic airflow limitation and designed to be self-completed by the participant. It consists of 76-items across three domains:
Each domain score ranges from 0 to 100 with higher scores indicating the worst health status. Total score was obtained by combining the weighted scores from each domain and ranging from 0 (better health) to 100 (Worst health). |
at Week 12 (V5)
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Change From Baseline in Pre-dose and in Post-dose Distance Walked (6 Minute Walking Test - 6MWT)
時間枠：Week 12 (V5), pre-dose and post-dose
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The 6MWT was carried out following standardized procedures, according to ATS guidelines.
The test was performed indoors, along a long, flat, straight, 30m-long corridor, and one well-trained researcher supervised the test.
Prior to start walking, patients were explained that the aim of the test was to walk from end to end along the corridor and to cover as much distance as possible in the period of 6 minutes.
The patients sit at rest for at least 10 minutes before the test start.
The longer distance covered, the better the outcome.
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Week 12 (V5), pre-dose and post-dose
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Change From Pre-dose in Post-dose Distance Walked (6MWT)
時間枠：on Week 0 (Day 1, V2) and Week 12 (V5, Day 84)
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The 6MWT was carried out following standardized procedures, according to ATS guidelines.
The test was performed indoors, along a long, flat, straight, 30m-long corridor, and one well-trained researcher supervised the test.
Prior to start walking, patients were explained that the aim of the test was to walk from end to end along the corridor and to cover as much distance as possible in the period of 6 minutes.
The patients sit at rest for at least 10 minutes before the test start.
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on Week 0 (Day 1, V2) and Week 12 (V5, Day 84)
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Number of Participants With COPD Exacerbations From Week 0 Through Week 12
時間枠：Week 12
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A COPD exacerbation is defined as "a sustained worsening of the participants condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and requires unscheduled medical intervention [leading to prescriptions of systemic corticosteroids (at least 3 days)] and/or antibiotics (at least 5 days), or need for a visit to an emergency department or hospitalization) in a participant with underlying COPD".
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Week 12
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
時間枠：From first dose of study drug until end of the treatment (up to 84 days)
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AE=An untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine. Serious AE= An adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. ADR=A response to a medicinal product which is harmful and unintended. Response in this context means that a causal relationship between the medicinal product and an adverse event is at least a reasonable possibility Serious ADR=An adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. Severe AE= "Severe" refers to the intensity of an AE; the event itself may be of relatively minor medical significance but intense. |
From first dose of study drug until end of the treatment (up to 84 days)
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協力者と研究者
捜査官
- 主任研究者：Dave Singh, MD、The Medicine Evaluation Unit - Manchester, UK
- 主任研究者：Jorgen Vestbo, MD、Dept. of Cardiology and Respiratory Medicine - Copenhagen, Denmark
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
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 (推定)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CCD-0910-PR-0021
- 2009-014410-10 (EudraCT番号)
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。