만성 폐쇄성 폐질환 환자에 대한 연구 (FUTURE)
Foster® 100/6(Beclomethasone Dipropionate 100µg Plus Formoterol 6µg/작동)의 효능과 안전성을 비교한 12주, 다기관, 다국적, 무작위, 이중 맹검, 이중 더미, 2군 병렬 그룹 연구, 2 만성폐쇄성폐질환 환자의 퍼프 b.i.d., Seretide® 500/50(플루티카손 500µg + 살메테롤 50µg/작동), 1회 흡입 b.i.d.
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Aarhus, 덴마크
- Aarhus University Hospital
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Copenhagen, 덴마크
- Bispebjerg Hospital
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Copenhagen, 덴마크
- Dept. of Cardiology and Respiratory Medicine
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Gentofte Municipality, 덴마크
- Gentofte Hospital
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Odense, 덴마크
- Odense University Hospital
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Berlin, 독일
- Praxis Dr. Jorg Kampschulte
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Leipzig, 독일
- Praxis Dr. Jörg Winkler
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Lübeck, 독일
- KLB Healthresearch
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Lübeck, 독일
- KLD Helthreseach
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Magdeburg, 독일
- SMO.MD GmbH Zentrum für Klinische Studien
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Saarbrücken, 독일
- Pneumologische Gemeinschaftspraxis Saarbrücken
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Wedel, 독일
- Fachinternistische Gemeinschafts
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Wiesloch, 독일
- Pneumologische Praxis Dr Redlich
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Wuppertal, 독일
- Gemeinschaftspraxis für Pneumologie
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Barcelona, 스페인
- Hospital Del Mar
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Sabadell, 스페인
- Hospital Parc Tauli
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Vic, 스페인
- Hospital General Vic
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Humenné, 슬로바키아
- Neštátna ambulancia pneumológie a ftizeológie, Nemocničná
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Nové Zámky, 슬로바키아
- Diunea, sro. Ambulancia PaF
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Ostrov, 슬로바키아
- ALERGOIMUNO s.r.o
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Poprad, 슬로바키아
- Pľúcna ambulancia, Poliklinika ADUS
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Prešov, 슬로바키아
- PULMO, s.r.o
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Prievidza, 슬로바키아
- PNEUMO-MED, s.r.o
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Spišská Nová Ves, 슬로바키아
- Pľúcna ambulancia, Hrebenár s.r.o
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Trnava, 슬로바키아
- PNEUMO-CENTRUM, s.r.o, Poliklinika
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Belfast, 영국
- Belfast City Hospital
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London, 영국
- Kings College Hospital
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Newcastle, 영국
- Freeman Hospital
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Bologna, 이탈리아
- Ospedale Sant'Orsola-Malpighi
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Catania, 이탈리아
- A.O. Policlinico
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Monza, 이탈리아
- A.O. S. Gerardo
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Naples, 이탈리아
- Azienda Ospedaliera Monaldi
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Pisa, 이탈리아
- Universita di Pisa
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Roma, 이탈리아
- IRCCS San Raffaele La Pisana
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Rome, 이탈리아, 00161
- Policlinico Umberto I - VIII Padiglione
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Adana, 터키 (Türkiye)
- Çukurova Üniversitesi
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Antalya, 터키 (Türkiye)
- Akdeniz Universitesi
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Antalya, 터키 (Türkiye)
- Bilim Üniversitesi
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Bornova, 터키 (Türkiye)
- Ege Üniversitesi
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Bursa, 터키 (Türkiye)
- Uludağ Üniversitesi
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Gaziantep, 터키 (Türkiye)
- Gaziantep Üniversitesi
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Istanbul, 터키 (Türkiye)
- Fatih Üniversitesi
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Istanbul, 터키 (Türkiye)
- Marmara Üniversitesi
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Izmir, 터키 (Türkiye)
- Dokuz Eylul Universitesi
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Kayseri, 터키 (Türkiye)
- Erciyes Üniversitesi
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Gdansk, 폴란드
- NZOZ "Non Nocere"
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Koszalin, 폴란드
- Niepubliczny Zakład Opieki Zdrowotnej "PROFILAKTYKA"
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Krakow, 폴란드
- Szpital Uniwersytecki w Krakowie
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Krakow, 폴란드
- Szpital Specjalistyczny im Jana Pawła II
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Lodz, 폴란드
- Prywatny Gabinet Specjalistyczny
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Szczecin, 폴란드
- Samodzielny Publiczny Szpital Kliniczny
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Warsaw, 폴란드
- Chorób Płuc
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Warsaw, 폴란드
- Gabinet Lekarski SERIA IWONA GRZELEWSKA-RZYMOWSKA
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Warsaw, 폴란드
- Instytut Gruźlicy i Chorób Płuc. Zakład Diagnostyki i Leczenia Niewydolności Oddychania
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Warsaw, 폴란드
- Zakład Fizjopatologii Oddychania, Instytut Gruźlicy i Chorób Płuc
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Wroclaw, 폴란드
- DOBROSTAN - Gabinety Lekarskie
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Wroclaw, 폴란드
- NZOZ Lekarze Specjaliści J.Małolepszy i Partnerzy
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Zgierz, 폴란드
- Wojewódzki Szpital Specjalistyczny im. M. Curie-Skłodowskiej)
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Toulon, 프랑스
- Centre Hospitalier
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Balassagyarmat, 헝가리
- Dr. Kenessey Albert Kórház - Rendelőintézet
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Budapest, 헝가리
- Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház
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Békés, 헝가리
- Békés Megyei Képviselő-testület Pándy Kálmán Kórház
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Debrecen, 헝가리
- Centrum-Tüdőgyógyászati Klinika
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Kecskemét, 헝가리
- Bács-Kiskun Megeyi Önkormanyzat...
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Mosonmagyaróvár, 헝가리
- Karolina Kórház és Rendelőintézet Tüdőgyógyászat
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Nyíregyháza, 헝가리
- Jósa András Hospital
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Nyíregyháza, 헝가리
- Békés Megyei Képviselő-testület Pándy Kálmán Kórház
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Szigetszentmiklös, 헝가리
- Chiesi Clinical Centre Szigetszentmiklös
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
포함 기준:
- 연구 관련 절차를 시작하기 전에 사전 동의서에 서명했거나 법적 대리인이 얻은 해당 서면 동의서에 서명한 40세 이상의 남성 또는 여성 환자.
COPD 진단을 받고 다음을 포함하는 외래 환자:
- [(하루에 피운 담배 수) x (흡연 연수) / 20]으로 정의되는 최소 10갑년의 흡연력, 현재 및 이전 흡연자 모두 자격이 있습니다.
- 지난 2개월 동안 기관지확장제를 사용하여 방문 1.
- 기관지확장제 후 FEV1 < 예측된 정상 값의 60%.
- 기관지확장제 후 FEV1/FVC < 0.7.
- 가역성 테스트에 대한 ≥ 5% 반응.
- 기준선 호흡곤란 지수(BDI) 초점 점수가 10 이하(방문 2에서도 충족됨).
- 지난 12개월 동안(지난 2개월을 고려하지 않고) 1번 이상의 COPD 악화 이력이 없는 경우 1을 방문하십시오.
- pMDI 및 DPI(Accuhaler®, 원형 성형 플라스틱 흡입기) 흡입기의 적절한 사용에 대한 훈련을 받는 협조적인 태도 및 능력.
주요 배제 기준:
- 임상적으로 관련된 호흡기 장애.
- COPD 이외의 천식 또는 호흡기 장애의 현재 진단.
- 조사자의 판단에 따라 연구 결과의 타당성에 영향을 미칠 수 있는 중요하거나 불안정한 동반 질병을 나타내는 임상적으로 중요한 검사실 및 ECG 이상.
- 스크리닝 전 2개월 및 연구 기간 동안 COPD 악화가 있는 환자.
- 만성 저산소증에 대해 장기간(매일 12시간 이상) 산소 요법이 필요한 환자.
- 1차 방문 전 2개월 동안 및 도입 기간 동안 데포 코르티코스테로이드로 치료받은 환자.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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
다른 이름들:
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활성 비교기: 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
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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AUC 0-30min Standardized by Time of Change From Pre-dose in FEV1 in the Morning of Day 84
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Dave Singh, MD, The Medicine Evaluation Unit - Manchester, UK
- 수석 연구원: Jorgen Vestbo, MD, Dept. of Cardiology and Respiratory Medicine - Copenhagen, Denmark
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CCD-0910-PR-0021
- 2009-014410-10 (EudraCT 번호)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .