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COPD의 Tiotropium/Salmeterol 흡입 분말

2026년 6월 18일 업데이트: Boehringer Ingelheim

TioSal 콤보 요법과 단일 제제 요법(Spiriva HandiHaler 및 Salmeterol PE 캡슐)을 비교하는 1년 연구

이 연구의 주요 목적은 FEV1에 의해 결정된 기관지확장제 효능, BDI/TDI에 의해 결정된 호흡곤란에 대한 영향, SGRQ에 의해 결정된 건강 상태에 대한 영향 및 COPD 악화에 대한 영향을 평가하는 것입니다.

연구 개요

상태

종료됨

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

207

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 남아프리카
      • Bellville, 남아프리카
        • 1184.15.27051
      • Cape Town, 남아프리카
        • 1184.15.27052
      • Somerset West, 남아프리카
        • 1184.15.27053
  • 네덜란드
      • Breda, 네덜란드
        • 1184.15.31051 Boehringer Ingelheim Investigational Site
      • Utrecht, 네덜란드
        • 1184.15.31054 Boehringer Ingelheim Investigational Site
      • Zutphen, 네덜란드
        • 1184.15.31052 Boehringer Ingelheim Investigational Site
  • 대한민국
      • Jeonju, 대한민국
        • 1184.15.82051 Boehringer Ingelheim Investigational Site
      • Suwon, 대한민국
        • 1184.15.82052 Boehringer Ingelheim Investigational Site
      • Wŏnju, 대한민국
        • 1184.15.82053 Boehringer Ingelheim Investigational Site
  • 덴마크
      • Aalborg, 덴마크
        • 1184.15.45054 Boehringer Ingelheim Investigational Site
      • Kolding, 덴마크
        • 1184.15.45052 Boehringer Ingelheim Investigational Site
      • Odense C, 덴마크
        • 1184.15.45051 Boehringer Ingelheim Investigational Site
      • Silkeborg, 덴마크
        • 1184.15.45053 Boehringer Ingelheim Investigational Site
  • 독일
      • Aschaffenburg, 독일
        • 1184.15.49056 Boehringer Ingelheim Investigational Site
      • Frankfurt, 독일
        • 1184.15.49053 Boehringer Ingelheim Investigational Site
      • Gelnhausen, 독일
        • 1184.15.49057 Boehringer Ingelheim Investigational Site
      • Hanover, 독일
        • 1184.15.49052 Boehringer Ingelheim Investigational Site
      • Hanover, 독일
        • 1184.15.49058 Boehringer Ingelheim Investigational Site
  • 라트비아
      • Balvi, 라트비아
        • 1184.15.37154 Boehringer Ingelheim Investigational Site
      • Jelgava, 라트비아
        • 1184.15.37152 Boehringer Ingelheim Investigational Site
      • Tukums, 라트비아
        • 1184.15.37153 Boehringer Ingelheim Investigational Site
  • 리투아니아
      • Klaipėda, 리투아니아
        • 1184.15.37053 Boehringer Ingelheim Investigational Site
  • 미국
    • Alabama
      • Anniston, Alabama, 미국
        • 1184.15.01069 Boehringer Ingelheim Investigational Site
      • Mobile, Alabama, 미국
        • 1184.15.01071 Boehringer Ingelheim Investigational Site
    • Florida
      • Clearwater, Florida, 미국
        • 1184.15.01054 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, 미국
        • 1184.15.01063 Boehringer Ingelheim Investigational Site
      • Tampa, Florida, 미국
        • 1184.15.01064 Boehringer Ingelheim Investigational Site
    • Georgia
      • Savannah, Georgia, 미국
        • 1184.15.01065 Boehringer Ingelheim Investigational Site
    • Louisiana
      • New Orleans, Louisiana, 미국
        • 1184.15.01052 Boehringer Ingelheim Investigational Site
    • Missouri
      • St Louis, Missouri, 미국
        • 1184.15.01055 Boehringer Ingelheim Investigational Site
      • St Louis, Missouri, 미국
        • 1184.15.01058 Boehringer Ingelheim Investigational Site
      • St Louis, Missouri, 미국
        • 1184.15.01062 Boehringer Ingelheim Investigational Site
    • New Jersey
      • Summit, New Jersey, 미국
        • 1184.15.01072 Boehringer Ingelheim Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, 미국
        • 1184.15.01053 Boehringer Ingelheim Investigational Site
    • New York
      • New York, New York, 미국
        • 1184.15.01070 Boehringer Ingelheim Investigational Site
    • North Carolina
      • Elizabeth City, North Carolina, 미국
        • 1184.15.01057 Boehringer Ingelheim Investigational Site
    • South Carolina
      • Charleston, South Carolina, 미국
        • 1184.15.01059 Boehringer Ingelheim Investigational Site
    • West Virginia
      • Morgantown, West Virginia, 미국
        • 1184.15.01051 Boehringer Ingelheim Investigational Site
  • 스웨덴
      • Boden, 스웨덴
        • 1184.15.46053 Boehringer Ingelheim Investigational Site
      • Stockholm, 스웨덴
        • 1184.15.46051 Boehringer Ingelheim Investigational Site
  • 슬로바키아
      • Bratislava, 슬로바키아
        • 1184.15.42153 Boehringer Ingelheim Investigational Site
      • Bratislava, 슬로바키아
        • 1184.15.42154 Boehringer Ingelheim Investigational Site
  • 에스토니아
      • Kohtla-Järve, 에스토니아
        • 1184.15.37252 Boehringer Ingelheim Investigational Site
      • Tallinn, 에스토니아
        • 1184.15.37251 Boehringer Ingelheim Investigational Site
  • 오스트리아
      • Gänserndorf, 오스트리아
        • 1184.15.43052 Boehringer Ingelheim Investigational Site
      • Vienna, 오스트리아
        • 1184.15.43053 Boehringer Ingelheim Investigational Site
  • 이탈리아
      • Florence, 이탈리아
        • 1184.15.39051 Boehringer Ingelheim Investigational Site
  • 캐나다
    • British Columbia
      • Vancouver, British Columbia, 캐나다
        • 1184.15.02057 Boehringer Ingelheim Investigational Site
      • Vancouver, British Columbia, 캐나다
        • 1184.15.02059 Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton, Ontario, 캐나다
        • 1184.15.02055 Boehringer Ingelheim Investigational Site
      • Ottawa, Ontario, 캐나다
        • 1184.15.02058 Boehringer Ingelheim Investigational Site
      • Scarborough Village, Ontario, 캐나다
        • 1184.15.02051 Boehringer Ingelheim Investigational Site
      • Toronto, Ontario, 캐나다
        • 1184.15.02053 Boehringer Ingelheim Investigational Site
    • Quebec
      • Longueuil, Quebec, 캐나다
        • 1184.15.02060 Boehringer Ingelheim Investigational Site
      • Montreal, Quebec, 캐나다
        • 1184.15.02056 Boehringer Ingelheim Investigational Site
  • 프랑스
      • Marseille, 프랑스
        • 1184.15.3350A Boehringer Ingelheim Investigational Site
      • Nantes, 프랑스
        • 1184.15.3351A Boehringer Ingelheim Investigational Site
      • Paris, 프랑스
        • 1184.15.3352A Boehringer Ingelheim Investigational Site
  • 핀란드
      • Oulu, 핀란드
        • 1184.15.35852 Boehringer Ingelheim Investigational Site
      • Tampere, 핀란드
        • 1184.15.35851 Boehringer Ingelheim Investigational Site
  • 헝가리
      • Deszk, 헝가리
        • 1184.15.36055 Boehringer Ingelheim Investigational Site
      • Szarvas, 헝가리
        • 1184.15.36054 Boehringer Ingelheim Investigational Site
      • Szeged, 헝가리
        • 1184.15.36052 Boehringer Ingelheim Investigational Site
      • Érd, 헝가리
        • 1184.15.36053 Boehringer Ingelheim Investigational Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

40년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

기본:

COPD의 진단 기관지확장제 후 FEV1<80% 예측 및 FEV1/FVC<70% 예측

제외 기준:

기본:

COPD 이후 중요한 다른 질병 최근 MI 지난 1년 동안 중재 또는 약물 요법의 변경이 필요한 모든 불안정하거나 생명을 위협하는 심장 부정맥 지난 1년 동안 심부전으로 입원 천식 병력

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: FDC tiotropium / salmeterol (T+S_PE)
One fixed dose combination (FDC) capsule of inhalation powder containing 7.5 micrograms Tiotropium and 25 micrograms of salmeterol were administered orally once daily in the morning from blue HandiHaler® device for treatment duration of 24 weeks (+24 week extension). One capsule of inhalation powder of placebo was administered twice daily in the morning from the grey HandiHaler® device, and in the evening from blue HandiHaler® device. The morning and evening dose of study medication had to be taken at approximately the same time, the evening dose had to be taken approximately 12 hours after the morning dose. All medications were self-administered by patients.
의약품: Tiotropium/Salmeterol
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene (PE) Capsule
활성 비교기: tiotropium (Tio18GEL)
One dose gelatine capsule of inhalation powder containing 18 micrograms tiotropium was administered orally once daily in the morning from the grey HandiHaler® device for treatment duration of 24 weeks (+24 week extension). One capsule of inhalation powder of placebo was administered twice daily in the morning and evening from the blue HandiHaler® device. The morning and evening dose of study medication had to be taken at approximately the same time, the evening dose had to be taken approximately 12 hours after the morning dose. All medications were self-administered by patients.
의약품: 티오트로피움
티오트로피움 흡입 분말, 경질 젤라틴 캡슐(Spiriva®)
활성 비교기: salmeterol (Salm25PE)
One dose polyethylene capsule of inhalation powder containing 25 micrograms salmeterol was administered orally twice daily in the morning and evening from the blue HandiHaler® device for treatment duration of 24 weeks (+24 week extension). One capsule of inhalation powder of placebo was administered once daily in the morning from the grey HandiHaler® device. The morning and evening dose of study medication had to be taken at approximately the same time, the evening dose had to be taken approximately 12 hours after the morning dose. All medications were self-administered by patients.
의약품: 살메테롤
살메테롤 흡입 분말, 경질 PE 캡슐
활성 비교기: FDC tiotropium / salmeterol + salmeterol (T+S_PE / S25PE)
One fixed dose combination (FDC) capsule of inhalation powder containing 7.5 micrograms tiotropium and 25 micrograms salmeterol was administered orally once daily in the morning from the blue HandiHaler® device and one dose of inhalation powder containing 25 micrograms salmeterol was administered once daily in the evening from the blue HandiHaler® device for treatment duration of 24 weeks (+24 week extension). One capsule of inhalation powder of placebo was administered once daily in the morning from the grey HandiHaler® device. The morning and evening dose of study medication had to be taken at approximately the same time, the evening dose had to be taken approximately 12 hours after the morning dose. All medications were self-administered by patients.
의약품: 살메테롤
살메테롤 흡입 분말, 경질 PE 캡슐
의약품: Tiotropium/Salmeterol
Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene (PE) Capsule
위약 비교기: Placebo
One capsule of inhalation powder of placebo was administered daily in the morning from the blue and grey HandiHaler® device and in the evening from the blue HandiHaler® device for treatment duration of 12 weeks (Patients randomized into the placebo group will be re-assigned at random to one of the four active treatments (T+S_PE, Tio18GEL, Salm25PE, T+S_PE/S25PE) for the remaining 36 weeks of the 48-week study period.). The morning and evening dose of study medication had to be taken at approximately the same time, the evening dose had to be taken approximately 12 hours after the morning dose. All medications were self-administered by patients.
의약품: 위약
위약 흡입 분말, 경질 PE 캡슐 / 경질 젤라틴 캡슐

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at the End of the 12-week Treatment Period
기간: At baseline and week 12

Change from baseline in trough Forced Expiratory Volume in one second (FEV1) at the end of the 12-week treatment period is presented.

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. It is measured by a spirometer.

Trough FEV1 is defined as the pre-dose FEV1 measured in the clinic at the -10 minutes time point just prior to inhalation of the morning dose of randomised treatment.

Trough FEV1 response is defined as the change from baseline: Trough FEV1 response = Trough FEV1 - FEV1 (Baseline)
At baseline and week 12
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at the End of the 24-week Treatment Period
기간: At baseline and week 24

Change from baseline in trough Forced Expiratory Volume in one second (FEV1) at the end of the 24-week treatment period is presented.

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second.

Trough FEV1 is defined as the pre-dose FEV1 measured in the clinic at the -10 min time point just prior to inhalation of the morning dose of randomised treatment.
At baseline and week 24
Forced Expiratory Volume in One Second (FEV1) Area Under the Concentration-time Curve From 0 to 8h (AUC0-8h) Response at the End of the 12-week Treatment Period
기간: At baseline and at week 12: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.

Forced Expiratory Volume in one second (FEV1) area under the concentration-time curve from 0 to 8 hours (AUC0-8h) response at the end of the 12-week treatment period is presented.

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The FEV1 AUC0-8h is defined as the area under the FEV1 curve (AUC) normalized for time. It was calculated as area under the curve from zero time to 8 h using the trapezoidal rule divided by the corresponding duration (i.e. 8 h) to give the results in litres. The trough FEV1 was assigned to zero time. Trough FEV1 at baseline is defined as the pre-dose FEV1 measured in the clinic at the -10 minutes time point just prior to inhalation of the first morning dose of randomised treatment at the randomisation visit.

Response = FEV1 AUC0-8h at week 12 - trough FEV1 at baseline.
At baseline and at week 12: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Forced Expiratory Volume in One Second (FEV1) Area Under the Concentration-time Curve From 0 to 8h (AUC0-8h) Response at the End of the 24-week Treatment Period
기간: At baseline and at week 24: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.

Forced Expiratory Volume in one second (FEV1) area under the concentration-time curve from 0 to 8h (AUC0-8h) response at the end of the 24-week treatment period is presented.

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The FEV1 AUC0-8h is defined as the area under the FEV1 curve (AUC) normalized for time. It was calculated as area under the curve from zero time to 8 h using the trapezoidal rule divided by the corresponding duration (i.e. 8 h) to give the results in litres. The trough FEV1 was assigned to zero time. Trough FEV1 at baseline is defined as the pre-dose FEV1 measured in the clinic at the -10 minutes time point just prior to inhalation of the first morning dose of randomised treatment at the randomisation visit.

Response = FEV1 AUC0-8h at week 24 - trough FEV1 at baseline.
At baseline and at week 24: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Mahler Transition Dyspnoea Index (TDI) Focal Score at the End of the 12-week Treatment Period
기간: At the end of week 12

The Mahler Dyspnoea questionnaire is an instrument which measures change from baseline state in the severity of breathlessness (shortness of breath). It is based on the criteria of the various grades for change in functional impairment (any activities started or stopped?), change in magnitude of task (What activities cause breathlessness now?) and change in magnitude of effort (Need to pause while performing activities?), which causes breathlessness, each ranging from grade -3 (major deterioration) to +3 (major improvement).

The Transition Dyspnoea Index (TDI) focal score was calculated as the sum of these three components of the TDI, i.e. change in Functional Impairment, in Magnitude of Task and in Magnitude of Effort. Consequently, TDI ranges from -9 to +9 with a higher score indicating improvement.
At the end of week 12
Mahler Transition Dyspnoea Index (TDI) Focal Score at the End of the 24-week Treatment Period
기간: At the end of week 24

The Mahler Dyspnoea questionnaire is an instrument which measures the severity of breathlessness (shortness of breath) change from the baseline state. It is based on the criteria of the various grades for change in functional impairment (any activities started or stopped?), change in magnitude of task (What activities cause breathlessness now?) and change in magnitude of effort (Need to pause while performing activities?), which causes breathlessness, each ranging from grade -3 (major deterioration) to +3 (major improvement).

The Transition Dyspnoea Index (TDI) focal score was calculated as the sum of these three components of the TDI, i.e. change in Functional Impairment, in Magnitude of Task and in Magnitude of Effort. Consequently, TDI ranges from -9 to +9 with a higher score indicating improvement.
At the end of week 24
St George Respiratory Questionnaire (SGRQ) Total Score at the End of the 24-week Treatment Period (Based Upon Pooled Data From 48-week Sister Studies 1184.14 and 1184.15)
기간: At the end of week 24

The St George Respiratory Questionnaire (SGRQ) is designed as a supervised self-administered questionnaire that determines the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.

The evaluation SGRQ was planned to be based upon pooled data from 48-week sister studies 1184.14 and 1184.15.
At the end of week 24
Time to First Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Within 48 Weeks
기간: Up to 12 weeks
Time from start of treatment to first moderate to severe chronic obstructive pulmonary disease (COPD) exacerbation within 48 weeks is presented.
Up to 12 weeks
Number of Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Within 48 Weeks
기간: Up to 12 weeks.
Number of patients with moderate to severe chronic obstructive pulmonary disease (COPD) exacerbations within 48 weeks is presented.
Up to 12 weeks.

2차 결과 측정

결과 측정
측정값 설명
기간
Forced Expiratory Volume in One Second (FEV1) Area Under the Concentration-time Curve From 0 to 8h (AUC0-8h) Response After 4, 36 and 48 Weeks Treatment Period
기간: At baseline and at week 4: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.

Forced Expiratory Volume in one second (FEV1) area under the concentration-time curve from 0 to 8h (AUC0-8h) response after 4, 36 and 48 weeks treatment period is presented.

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The FEV1 AUC0-8h is defined as the area under the FEV1 curve (AUC) normalized for time. It was calculated as area under the curve from zero time to 8 h using the trapezoidal rule divided by the corresponding duration (i.e. 8 h) to give the results in litres. The trough FEV1 was assigned to zero time. Trough FEV1 at baseline is defined as the pre-dose FEV1 measured in the clinic at the -10 minutes time point just prior to inhalation of the first morning dose of randomised treatment at the randomisation visit.

Response = FEV1 AUC0-8h at week 4, 36 or 48 - trough FEV1 at baseline.
At baseline and at week 4: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) After 4, 36 and 48 Weeks Treatment Period
기간: At baseline and week 4.

Change from baseline in trough Forced Expiratory Volume in one second (FEV1) after 4, 36 and 48 weeks treatment period is presented.

FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. It is measured by a spirometer.

Trough FEV1 is defined as the pre-dose FEV1 measured in the clinic at the -10 minutes time point just prior to inhalation of the morning dose of randomised treatment.

Trough FEV1 response is defined as the change from baseline: Trough FEV1 response = Trough FEV1 - FEV1 (Baseline)
At baseline and week 4.
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) at Week 4, 12, 18, 24, 36 and 48
기간: At baseline and at week 4 and 12: within 3h after inhalation of the morning dose of randomised treatment.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Peak FEV1 is defined as the highest FEV1 reading observed within 3 hours after inhalation of the morning dose of randomised treatment. Peak FEV1 response is defined as the change from baseline: Peak FEV1 response = Peak FEV1 - FEV1 (Baseline)
At baseline and at week 4 and 12: within 3h after inhalation of the morning dose of randomised treatment.
The Forced Vital Capacity (FVC) Area Under the Concentration-time Curve From 0 to 8h (AUC0-8h) Response After 4, 12, 24, 36 and 48 Weeks Treatment Period
기간: At baseline and at week 4 and 12: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Forced Vital Capacity (FVC) is the volume of air (measured in milliliter) which can be forcibly exhaled from the lungs after taking the deepest breath possible. The FVC AUC0-8h is defined as the area under the FVC curve (AUC) normalized for time. It was calculated as area under the curve from zero time to 8 h using the trapezoidal rule divided by the corresponding duration (i.e. 8 h) to give the results in litres. The trough FVC was assigned to zero time. Trough FVC at baseline is defined as the pre-dose FVC measured in the clinic at the -10 minutes time point just prior to inhalation of the first morning dose of randomised treatment at the randomisation visit. Response = FVC AUC0-8h at week 4, 12, 24, 36 or 48 - trough FVC at baseline.
At baseline and at week 4 and 12: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Change From Baseline in Trough Forced Vital Capacity (FVC) After 4, 12, 24, 36 and 48 Weeks Treatment Period
기간: At baseline and week 4 and 12.
Forced Vital Capacity (FVC) is the volume of air (measured in millilitres) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC is defined as the pre-dose FVC measured in the clinic at the -10 minutes time point just prior to inhalation of the morning dose of randomised treatment. Trough FVC response is defined as the change from baseline: Trough FVC response = Trough FVC - FVC (Baseline)
At baseline and week 4 and 12.
Change From Baseline in Peak Forced Vital Capacity (FVC) at Week 4, 12, 18, 24, 36 and 48
기간: At baseline and at week 4 and 12: within 3 hours after inhalation of the morning dose of randomised treatment.
Forced Vital Capacity (FVC) is the volume of air (measured in millilitres) which can be forcibly exhaled from the lungs after taking the deepest breath possible. Peak FVC is defined as the highest FVC reading observed within 3 hours after inhalation of the morning dose of randomised treatment. Peak FVC response is defined as the change from baseline: Peak FVC response = Peak FVC - FVC (Baseline)
At baseline and at week 4 and 12: within 3 hours after inhalation of the morning dose of randomised treatment.
Forced Expiratory Volume in One Second (FEV1) at Clinic Visits at the Individual Times on Week 4
기간: At week 4: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Forced Expiratory Volume in one second (FEV1) at clinic visits at the individual times on week 4 is presented. FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. It is measured by a spirometer.
At week 4: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Forced Expiratory Volume in One Second (FEV1) at Clinic Visits at the Individual Times on Week 12
기간: At week 12: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Forced Expiratory Volume in one second (FEV1) at clinic visits at the individual times on week 12 is presented. FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. It is measured by a spirometer.
At week 12: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Forced Vital Capacity (FVC) at Clinic Visits at the Individual Times on Week 4
기간: At week 4: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Forced Vital Capacity (FVC) at clinic visits at the individual times on week 4 is presented. Forced Vital Capacity (FVC) is the volume of air (measured in millilitres) which can be forcibly exhaled from the lungs after taking the deepest breath possible.
At week 4: 10 minutes (min) prior to inhalation, and 30min, 60min, 2hours (hrs), 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Forced Vital Capacity (FVC) at Clinic Visits at the Individual Times on Week 12
기간: At week 12, at 10 min prior and 0 hours (hrs), 30 minutes (min), 1hrs, 2hrs, 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Forced Vital Capacity (FVC) at clinic visits at the individual times on week 12 is presented. Forced Vital Capacity (FVC) is the volume of air (measured in millilitres) which can be forcibly exhaled from the lungs after taking the deepest breath possible.
At week 12, at 10 min prior and 0 hours (hrs), 30 minutes (min), 1hrs, 2hrs, 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Peak Expiratory Flow (PEF) Rate at Clinic Visits at the Individual Times on Week 4
기간: At week 4, at 0 hours (hrs), 30 minutes (min), 1hrs, 2hrs, 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.

Peak expiratory flow (PEF) rate at clinic visits at the individual times on week 4 is presented. Patients received an electronic diary. Peak expiratory flows (PEFs) were determined individually at home and reported by the patient. PEF measurements was performed 10 minutes prior to the first dose of study medication, and at 30, 60 minutes, 2, 3, 4, 6 and 8 hours after inhalation of the first dose of randomised treatment. The measurements scheduled at 30 and 60 minutes after inhalation were obtained within ± 5 minutes of the specified time-points. Measurements scheduled at 2-8 hours after inhalation were obtained within ± 10 minutes of the specified time-points.

PEF is defined as a person's maximum speed of expiration after a full inspiration.
At week 4, at 0 hours (hrs), 30 minutes (min), 1hrs, 2hrs, 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Peak Expiratory Flow (PEF) Rate at Clinic Visits at the Individual Times on Week 12
기간: At week 12, at 0 hours (hrs), 30 minutes (min), 1hrs, 2hrs, 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Peak expiratory flow (PEF) rate at clinic visits at the individual times on week 12 is presented. Patients received an electronic diary. Peak expiratory flows (PEFs) were determined individually at home and reported by the patient. PEF measurements will be performed 10 minutes prior to the first dose of study medication, and at 30, 60 minutes, 2, 3, 4, 6 and 8 hours after inhalation of the first dose of randomised treatment. The measurements scheduled at 30 and 60 minutes after inhalation will be obtained within ± 5 minutes of the specified time-points.Measurements scheduled at 2-8 hours after inhalation will be obtained within ± 10 minutes of the specified time-points.
At week 12, at 0 hours (hrs), 30 minutes (min), 1hrs, 2hrs, 3hrs, 4hrs, 6hrs and 8hrs after inhalation of the morning drug dose.
Weekly Mean Morning Pre-dose Peak Expiratory Flows (PEFs)
기간: At week 1 to 14, each morning between 7 a.m. and 10 a.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication.
Weekly mean morning pre-dose peak expiratory flows (PEFs) is presented. Patients received an electronic diary. Peak expiratory flows (PEFs) were determined individually at home and reported by the patient. The pulmonary function test was obtained by spirometry. The best of three efforts was defined as the highest PEF. Patients did not take their morning study medications prior to each morning PEF measurement.
At week 1 to 14, each morning between 7 a.m. and 10 a.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication.
Weekly Mean Evening Pre-dose Peak Expiratory Flows (PEFs)
기간: At week 1 to 14, each evening between 7 p.m. and 10 p.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication.
Weekly mean evening pre-dose peak expiratory flows (PEFs) is presented. Patients received an electronic diary. Peak expiratory flows (PEFs) were determined individually at home and reported by the patient. The pulmonary function test was obtained by spirometry. The best of three efforts was defined as the highest PEF. Patients did not take their evening study medications prior to each evening PEF measurement.
At week 1 to 14, each evening between 7 p.m. and 10 p.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication.
Peak Expiratory Flow (PEF) Determined by Spirometry at Week 4, 12, 18, 24, 36 and 48
기간: At week 4 and 12: 10 minutes prior to the first dose of study medication, and at 30, 60 minutes, 2, 3, 4, 6 and 8 hours after inhalation of the first dose of randomised treatment.

Peak expiratory flow (PEF) are determined by spirometry at clinic visits (week 4, 12, 18, 24, 36 and 48) is presented.

Spirometry will begin between 07:00 and 10:00 a.m. PEF measurements will be performed 10 minutes prior to the first dose of study medication, and at 30, 60 minutes, 2, 3, 4, 6 and 8 hours after inhalation of the first dose of randomised treatment. The measurements scheduled at 30 and 60 minutes after inhalation will be obtained within ± 5 minutes of the specified time-points.Measurements scheduled at 2-8 hours after inhalation will be obtained within ± 10 minutes of the specified time-points.
At week 4 and 12: 10 minutes prior to the first dose of study medication, and at 30, 60 minutes, 2, 3, 4, 6 and 8 hours after inhalation of the first dose of randomised treatment.
Weekly Mean Morning Pre-dose Forced Expiratory Volume in One Second (FEV1)
기간: At week 1 to 14, each morning between 7 a.m. and 10 a.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication.
Weekly mean morning pre-dose Forced expiratory volume in one second (FEV1) is presented. 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 measurements are performed individually at home and reported by the patient. It is measured by a spirometer. The best of three efforts was defined as the highest FEV1. Patients did not take their morning study medications prior to each morning FEV1 measurement.
At week 1 to 14, each morning between 7 a.m. and 10 a.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication.
Weekly Mean Evening Pre-dose Forced Expiratory Volume in One Second (FEV1)
기간: At week 1 to 14, each evening between 7 p.m. and 10 p.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication.
Weekly mean evening pre-dose Forced expiratory volume in one second (FEV1) is presented. 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 measurements are performed individually at home and reported by the patient. It is measured by a spirometer. The best of three efforts was defined as the highest FEV1. Patients did not take their evening study medications prior to each evening FEV1 measurement.
At week 1 to 14, each evening between 7 p.m. and 10 p.m. (± 30 minutes (min)) at -10 min (± 3 min) prior to the administration of the study medication.
Weekly Mean Number Per Day (24 Hours Period) of Puffs of As-needed Salbutamol/Albuterol Metered Dose Inhaler (MDI)
기간: Weekly up to week 14: per day (24 hours period)

Weekly mean number per day of puffs of as-needed salbutamol/albuterol metered dose inhaler (MDI) is presented.

Patients inhaled puffs of rescue medication of 100 micrograms (μg) salbutamol/albuterol metered dose inhaler (MDI).
Weekly up to week 14: per day (24 hours period)
Weekly Mean Number at Daytime of Puffs of As-needed Salbutamol/Albuterol Metered Dose Inhaler (MDI)
기간: Weekly up to week 14: at daytime (from morning dose till evening dose of study medication)

Weekly mean number at daytime of puffs of as-needed salbutamol/albuterol metered dose inhaler (MDI) is presented.

Patients inhaled puffs of rescue medication of 100 micrograms (μg) salbutamol/albuterol metered dose inhaler (MDI).
Weekly up to week 14: at daytime (from morning dose till evening dose of study medication)
Weekly Mean Number at Nighttime of Puffs of As-needed Salbutamol/Albuterol Metered Dose Inhaler (MDI)
기간: Weekly up to week 14: at nighttime (from evening dose till morning dose of study medication)
Weekly mean number at nighttime of puffs of as-needed salbutamol/albuterol metered dose inhaler (MDI) is presented. Patients inhaled puffs of rescue medication of 100 micrograms (μg) salbutamol/albuterol metered dose inhaler (MDI).
Weekly up to week 14: at nighttime (from evening dose till morning dose of study medication)
Weekly Mean Number of Chronic Obstructive Pulmonary Disease (COPD)-Related Nighttime Awakenings
기간: Per week, up to 14 weeks
Weekly mean number of chronic obstructive pulmonary disease (COPD)-related nighttime awakenings is presented.
Per week, up to 14 weeks
Mahler Transition Dyspnoea Index (TDI) Focal Score Collected After 4, 36 and 48 Weeks Treatment Period
기간: At week 4.

The Mahler Dyspnoea questionnaire is an instrument which measures change from baseline state in the severity of breathlessness (shortness of breath). It is based on the criteria of the various grades for change in functional impairment (any activities started or stopped?), change in magnitude of task (What activities cause breathlessness now?) and change in magnitude of effort (Need to pause while performing activities?), which causes breathlessness, each ranging from grade -3 (major deterioration) to +3 (major improvement).

The Transition Dyspnoea Index (TDI) focal score was calculated as the sum of these three components of the TDI, i.e. change in Functional Impairment, in Magnitude of Task and in Magnitude of Effort. Consequently, TDI ranges from -9 to +9 with a higher score indicating improvement.
At week 4.
Mahler Transition Dyspnoea Index (TDI) Domain Score - Functional Impairment Collected After 4, 12, 24, 36 and 48 Weeks Treatment Period
기간: At the end of week 4 and 12.
The Mahler Dyspnoea questionnaire is an instrument which measures change from baseline state in the severity of breathlessness (shortness of breath). It is based on the criteria of the various grades for change in functional impairment (any activities started or stopped?), change in magnitude of task (What activities cause breathlessness now?) and change in magnitude of effort (Need to pause while performing activities?), which causes breathlessness, each ranging from grade -3 (major deterioration) to +3 (major improvement).
At the end of week 4 and 12.
Mahler Transition Dyspnoea Index (TDI) Domain Score - Magnitude of Task Collected After 4, 12, 24, 36 and 48 Weeks Treatment Period
기간: At the end of week 4 and 12.
The Mahler Dyspnoea questionnaire is an instrument which measures the severity of breathlessness (shortness of breath) change from the baseline state. The Mahler Transition Dyspnoea Index (TDI) domain score - magnitude of task is based on the criteria of change in magnitude of task (What activities cause breathlessness now?) which causes breathlessness, ranging from grade -3 (major deterioration) to +3 (major improvement).
At the end of week 4 and 12.
Mahler Transition Dyspnoea Index (TDI) Domain Score - Magnitude of Effort Collected After 4, 12, 24, 36 and 48 Weeks Treatment Period
기간: At the end of week 4 and 12.
The Mahler Dyspnoea questionnaire is an instrument which measures the severity of breathlessness (shortness of breath) change from the baseline state. The Mahler Transition Dyspnoea Index (TDI) domain score - magnitude of effort is based on the criteria of change in magnitude of effort (Need to pause while performing activities?) which causes breathlessness, ranging from grade -3 (major deterioration) to +3 (major improvement).
At the end of week 4 and 12.
St George Respiratory Questionnaire (SGRQ) Total Score Collected at 4, 12, 36 and 48 Weeks
기간: At week 4 and 12.
The St George Respiratory Questionnaire (SGRQ) is designed as a supervised self-administered questionnaire that determines the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
At week 4 and 12.
St George Respiratory Questionnaire (SGRQ) Impact Domain Score Collected at 4, 12, 36 and 48 Weeks
기간: At week 4 and 12.
The St George Respiratory Questionnaire (SGRQ) is designed as a supervised self-administered questionnaire that determines the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. The impact domain score is a part of the SGRQ that measures the impact of disease on daily life. Scores range from 0 to 100, with higher scores indicating more limitations.
At week 4 and 12.
St George Respiratory Questionnaire (SGRQ) Activity Domain Score Collected at 4, 12, 36 and 48 Weeks
기간: At week 4 and 12.
The St George Respiratory Questionnaire (SGRQ) is designed as a supervised self-administered questionnaire that determines the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. The activity domain score is a part of the SGRQ that measures the activity of the patient. Scores range from 0 to 100, with higher scores indicating more limitations.
At week 4 and 12.
St George Respiratory Questionnaire (SGRQ) Symptoms Domain Score Collected at 4, 12, 36 and 48 Weeks
기간: At week 4 and 12.
The St George Respiratory Questionnaire (SGRQ) is designed as a supervised self-administered questionnaire that determines the impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. The symptoms domain score is a part of the SGRQ that measures the symptoms of the patient. Scores range from 0 to 100, with higher scores indicating more limitations.
At week 4 and 12.
Number of Patients With Adverse Events Within the 48-week Treatment Period
기간: From randomisation till end of treatment, up to 12 weeks.

Number of patients with adverse events within the 48-week treatment period is presented.

A patient may be counted in more than one seriousness criterion.
From randomisation till end of treatment, up to 12 weeks.
Number of Patients With Marked Changes in Vital Signs (Decrease) by Clinic Visit
기간: At baseline, week 4 and week 12.

Number of patients with marked changes in vital signs (decrease) by clinic visit is presented.

Vital signs: pulse rate and blood pressure (BP) (after five minutes rest in seated position) recorded pre-dose on each pulmonary function test day and in conjunction with spirometry for the first 3 hours post-dosing.

Systolic BP Decrease: Below 100 mmHg if not at that level at baseline and a decrease of greater than 10 mmHg below baseline.

Diastolic BP Decrease: Below 60 mmHg if not at that level at baseline and a decrease of greater than 10 mmHg below baseline.

Pulse rate Decrease: Below 60 bpm if not at that level at baseline and a decrease of greater than 10 bpm below baseline.
At baseline, week 4 and week 12.
Number of Patients With Marked Changes in Vital Signs (Increase) by Clinic Visit
기간: At baseline, week 4 and week 12.

Number of patients with marked changes in vital signs (increase) by clinic visit is presented.

Vital signs: pulse rate and blood pressure 8BP) (after five minutes rest in seated position) recorded pre-dose on each pulmonary function test-day and in conjunction with spirometry for the first 3 hours post-dosing.

Systolic BP Increase : An increase of 25 mmHg or more above baseline. Diastolic BP Increase: Above 90 mmHg and an increase of greater than 10 mmHg above baseline.

Pulse rate Increase : Greater than 100 bpm if not at that level at baseline and an increase greater than 10 % above baseline.
At baseline, week 4 and week 12.
Number of Patients With Abnormal Haematology at the End of the 12-week Treatment Period
기간: At the end of the 12-week treatment period.
Number of patients with abnormal haematology at the end of the 12-week treatment period is presented.
At the end of the 12-week treatment period.
Number of Patients With Abnormal Blood Chemistry at the End of the 12-week Treatment Period
기간: At the end of the 12-week treatment period.
Number of patients with abnormal blood chemistry at the end of the 12-week treatment period is presented.
At the end of the 12-week treatment period.
Number of Patients With Abnormal Urinalysis at the End of the 12-week Treatment Period
기간: At the end of the 12-week treatment period.
Number of patients with abnormal urinalysis at the end of the 12-week treatment period is presented.
At the end of the 12-week treatment period.
Vital Status of Randomised Patients
기간: Up to 48 weeks.
Vital status of randomised patients is presented.
Up to 48 weeks.
Number of Days in Hospital Within the 48-week Treatment Period
기간: Up to 12 weeks.
Number of days in hospital within the 48-week treatment period is presented.
Up to 12 weeks.
Number of Unscheduled Health Care Provider Visits Within the 48-week Treatment Period
기간: Up to 12 weeks.
Number of unscheduled health care provider visits within the 48-week treatment period is presented.
Up to 12 weeks.
Number of Emergency Room Visits Within the 48-week Treatment Period
기간: Up to 12 weeks.
Number of emergency room visits within the 48-week treatment period is presented.
Up to 12 weeks.
Number of Days in Intensive Care Unit Within the 48-week Treatment Period
기간: Up to 12 weeks.
Number of days in intensive care unit within the 48-week treatment period is presented.
Up to 12 weeks.
Number of Patients Receiving Concomitant Medication
기간: Up to 12 weeks.
Number of patients receiving concomitant medication is presented. Concomitant medication was observed for rerandomized placebo patients during placebo treatment and on-treatment periods.
Up to 12 weeks.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Boehringer Ingelheim

수사관

  • 연구 의자: Boehringer Ingelheim, Boehringer Ingelheim

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2008년 4월 15일

기본 완료 (실제)

2008년 11월 21일

연구 완료 (실제)

2008년 11월 21일

연구 등록 날짜

최초 제출

2008년 4월 17일

QC 기준을 충족하는 최초 제출

2008년 4월 28일

처음 게시됨 (추정된)

2008년 4월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 18일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 1184.15
  • 2007-005107-17 (EudraCT 번호: EudraCT)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD 공유 기간

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD 공유 액세스 기준

For study documents - upon signing of a 'Document Sharing Agreement'.

For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

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. .

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