慢性阻塞性肺疾病患者的研究 (FUTURE)
一项为期 12 周、多中心、多国、随机、双盲、双模拟、双臂平行组研究，比较 Foster® 100/6（双丙酸倍氯米松 100 µg 加福莫特罗 6 µg/启动）的功效和安全性，2粉扑 b.i.d.，对比 Seretide® 500/50（氟替卡松 500 µg 加沙美特罗 50 µg/致动），1 次吸入 b.i.d.，用于慢性阻塞性肺病患者
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Aarhus、丹麦
- Aarhus University Hospital
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Copenhagen、丹麦
- Bispebjerg Hospital
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Copenhagen、丹麦
- Dept. of Cardiology and Respiratory Medicine
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Gentofte Municipality、丹麦
- Gentofte Hospital
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Odense、丹麦
- Odense University Hospital
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Balassagyarmat、匈牙利
- Dr. Kenessey Albert Kórház - Rendelőintézet
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Budapest、匈牙利
- Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház
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Békés、匈牙利
- Békés Megyei Képviselő-testület Pándy Kálmán Kórház
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Debrecen、匈牙利
- Centrum-Tüdőgyógyászati Klinika
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Kecskemét、匈牙利
- Bács-Kiskun Megeyi Önkormanyzat...
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Mosonmagyaróvár、匈牙利
- Karolina Kórház és Rendelőintézet Tüdőgyógyászat
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Nyíregyháza、匈牙利
- Jósa András Hospital
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Nyíregyháza、匈牙利
- Békés Megyei Képviselő-testület Pándy Kálmán Kórház
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Szigetszentmiklös、匈牙利
- Chiesi Clinical Centre Szigetszentmiklös
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Adana、土耳其（türkiye）
- Çukurova Üniversitesi
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Antalya、土耳其（türkiye）
- Akdeniz Universitesi
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Antalya、土耳其（türkiye）
- Bilim Üniversitesi
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Bornova、土耳其（türkiye）
- Ege Üniversitesi
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Bursa、土耳其（türkiye）
- Uludağ Üniversitesi
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Gaziantep、土耳其（türkiye）
- Gaziantep Üniversitesi
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Istanbul、土耳其（türkiye）
- Fatih Üniversitesi
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Istanbul、土耳其（türkiye）
- Marmara Üniversitesi
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Izmir、土耳其（türkiye）
- Dokuz Eylul Universitesi
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Kayseri、土耳其（türkiye）
- Erciyes Üniversitesi
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Berlin、德国
- Praxis Dr. Jorg Kampschulte
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Leipzig、德国
- Praxis Dr. Jörg Winkler
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Lübeck、德国
- KLB Healthresearch
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Lübeck、德国
- KLD Helthreseach
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Magdeburg、德国
- SMO.MD GmbH Zentrum für Klinische Studien
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Saarbrücken、德国
- Pneumologische Gemeinschaftspraxis Saarbrücken
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Wedel、德国
- Fachinternistische Gemeinschafts
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Wiesloch、德国
- Pneumologische Praxis Dr Redlich
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Wuppertal、德国
- Gemeinschaftspraxis für Pneumologie
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Bologna、意大利
- Ospedale Sant'Orsola-Malpighi
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Catania、意大利
- A.O. Policlinico
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Monza、意大利
- A.O. S. Gerardo
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Naples、意大利
- Azienda Ospedaliera Monaldi
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Pisa、意大利
- Universita di Pisa
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Roma、意大利
- IRCCS San Raffaele La Pisana
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Rome、意大利、00161
- Policlinico Umberto I - VIII Padiglione
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Humenné、斯洛伐克
- Neštátna ambulancia pneumológie a ftizeológie, Nemocničná
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Nové Zámky、斯洛伐克
- Diunea, sro. Ambulancia PaF
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Ostrov、斯洛伐克
- ALERGOIMUNO s.r.o
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Poprad、斯洛伐克
- Pľúcna ambulancia, Poliklinika ADUS
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Prešov、斯洛伐克
- PULMO, s.r.o
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Prievidza、斯洛伐克
- PNEUMO-MED, s.r.o
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Spišská Nová Ves、斯洛伐克
- Pľúcna ambulancia, Hrebenár s.r.o
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Trnava、斯洛伐克
- PNEUMO-CENTRUM, s.r.o, Poliklinika
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Toulon、法国
- Centre Hospitalier
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Gdansk、波兰
- NZOZ "Non Nocere"
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Koszalin、波兰
- Niepubliczny Zakład Opieki Zdrowotnej "PROFILAKTYKA"
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Krakow、波兰
- Szpital Uniwersytecki w Krakowie
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Krakow、波兰
- Szpital Specjalistyczny im Jana Pawła II
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Lodz、波兰
- Prywatny Gabinet Specjalistyczny
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Szczecin、波兰
- Samodzielny Publiczny Szpital Kliniczny
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Warsaw、波兰
- Chorób Płuc
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Warsaw、波兰
- Gabinet Lekarski SERIA IWONA GRZELEWSKA-RZYMOWSKA
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Warsaw、波兰
- Instytut Gruźlicy i Chorób Płuc. Zakład Diagnostyki i Leczenia Niewydolności Oddychania
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Warsaw、波兰
- Zakład Fizjopatologii Oddychania, Instytut Gruźlicy i Chorób Płuc
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Wroclaw、波兰
- DOBROSTAN - Gabinety Lekarskie
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Wroclaw、波兰
- NZOZ Lekarze Specjaliści J.Małolepszy i Partnerzy
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Zgierz、波兰
- Wojewódzki Szpital Specjalistyczny im. M. Curie-Skłodowskiej)
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Belfast、英国
- Belfast City Hospital
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London、英国
- Kings College Hospital
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Newcastle、英国
- Freeman Hospital
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Barcelona、西班牙
- Hospital Del Mar
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Sabadell、西班牙
- Hospital Parc Tauli
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Vic、西班牙
- Hospital General Vic
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准：
- 年龄≥ 40 岁的男性或女性患者，在开始任何研究相关程序之前签署了知情同意书或曾获得法定代表人的适用书面知情同意书。
诊断为 COPD 的门诊患者，包括：
- 至少 10 包年的吸烟史定义为 [（每天吸的香烟数）x（吸烟年数）/ 20]，当前和戒烟者均符合资格。
- 前 2 个月内使用支气管扩张剂就诊 1.
- 支气管扩张剂后 FEV1 < 预计正常值的 60%。
- 支气管扩张剂后 FEV1/FVC < 0.7。
- 对可逆性测试的响应≥ 5%。
- 基线呼吸困难指数 (BDI) 焦点评分小于或等于 10（也将在访问 2 时满足）。
- 在过去 12 个月（不考虑过去 2 个月）中有不超过一次 COPD 急性加重史 访问 1。
- 接受培训以正确使用 pMDI 和 DPI（Accuhaler®，圆形模压塑料吸入器）吸入器的合作态度和能力。
主要排除标准：
- 临床相关的呼吸系统疾病。
- 当前诊断为除 COPD 以外的哮喘或呼吸系统疾病。
- 临床上显着的实验室和心电图异常表明存在显着或不稳定的伴随疾病，根据研究者的判断，这可能会影响研究结果的可行性。
- 在筛选前 2 个月和研究期间出现 COPD 恶化的患者。
- 因慢性低氧血症需要长期（每天至少 12 小时）氧疗的患者。
- 在就诊 1 前的 2 个月和磨合期接受长效皮质类固醇治疗的患者。
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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
其他名称：
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有源比较器：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
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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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
大体时间：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
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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AUC 0-30min Standardized by Time of Change From Pre-dose in FEV1 in the Morning of Day 84
大体时间：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
大体时间：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
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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)
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Dave Singh, MD、The Medicine Evaluation Unit - Manchester, UK
- 首席研究员：Jorgen Vestbo, MD、Dept. of Cardiology and Respiratory Medicine - Copenhagen, Denmark
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CCD-0910-PR-0021
- 2009-014410-10 (EudraCT编号)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.