이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Efficacy and Safety of Indacaterol Plus Tiotropium Versus Tiotropium Alone in Patients With Chronic Obstructive Pulmonary Disease (INTRUST1)

2011년 7월 22일 업데이트: Novartis Pharmaceuticals

A Randomized, Double-blind, Controlled, Parallel-group, 12-week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease

This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

1134

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 과테말라
      • Guatemala, 과테말라
        • Novartis Investigative Site
      • Guatemala City, 과테말라
        • Novartis Investigative Site
  • 남아프리카
      • Amanzimtoti, 남아프리카
        • Novartis Investigator Site
      • Cape Town, 남아프리카
        • Novartis Investigator Site
      • Johannesburg, 남아프리카
        • Novartis Investigator Site
      • Midrand, 남아프리카
        • Novartis Investigator Site
      • Umkomaas, 남아프리카
        • Novartis Investigator Site
  • 덴마크
      • Copenhagen, 덴마크
        • Novartis Investigator Site
      • Fredericia, 덴마크
        • Novartis Investigator Site
      • Silkeborg, 덴마크
        • Novartis Investigator Site
      • Soeborg, 덴마크
        • Novartis Investigator Site
      • Vejle, 덴마크
        • Novartis Investigator Site
  • 독일
      • Berlin, 독일
        • Novartis Investigator Site
      • Cottbus, 독일
        • Novartis Investigator Site
      • Donaustauf, 독일
        • Novartis Investigator Site
      • Dortmund, 독일
        • Novartis Investigator Site
      • Erfurt, 독일
        • Novartis Investigator Site
      • Frankfurt, 독일
        • Novartis Investigator Site
      • Gelnhausen, 독일
        • Novartis Investigator Site
      • Grosshansdorf, 독일
        • Novartis Investigator Site
      • Hannover, 독일
        • Novartis Investigator Site
      • Heidelberg, 독일
        • Novartis Investigator Site
      • Leipzig, 독일
        • Novartis Investigator Site
      • Mainz, 독일
        • Novartis Investigator Site
      • Neu-Ulm, 독일
        • Novartis Investigator Site
      • Neuss, 독일
        • Novartis Investigator Site
      • Potsdam, 독일
        • Novartis Investigator Site
      • Rostock, 독일
        • Novartis Investigator Site
      • Schwabach, 독일
        • Novartis Investigator Site
      • Schwetzingen, 독일
        • Novartis Investigator Site
      • Straussberg, 독일
        • Novartis Investigator Site
      • Wiesbaden, 독일
        • Novartis Investigative Site
      • Wuppertal, 독일
        • Novartis Investigator Site
  • 멕시코
      • Guadalajara, 멕시코
        • Novartis Investigative Site
      • Mexico City, 멕시코
        • Novartis Investigator Site
      • Monterrey, 멕시코
        • Novartis Investigative Site
      • Zapopan, 멕시코
        • Novartis Investigative Site
  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 32509
        • Novartis Investigator Site
      • Mobile, Alabama, 미국, 36608
        • Novartis Investigator Site
    • Arizona
      • Scottsdale, Arizona, 미국, 85258
        • Novartis Investigative Site
      • Tucson, Arizona, 미국, 85723
        • Novartis Investigative Site
      • Tucson, Arizona, 미국, 85712
        • Novartis Investigative Site
    • Arkansas
      • Pine Bluff, Arkansas, 미국, 71603
        • Novartis Investigator Site
    • California
      • Fountain Valley, California, 미국, 92708
        • Novartis Investigator Site
      • Long Beach, California, 미국, 90822
        • Novartis Investigator Site
      • Los Angeles, California, 미국, 90095
        • Novartis Investigative Site
      • National City, California, 미국, 91950
        • Novartis Investigator Site
      • Palmdale, California, 미국, 93551
        • Novartis Investigator Site
      • Stockton, California, 미국, 95207
        • Novartis Investigative Site
      • Temecula, California, 미국, 92591
        • Novartis Investigator Site
    • Connecticut
      • Hartford, Connecticut, 미국, 06105-1208
        • Novartis Investigative Site
    • Florida
      • Clearwater, Florida, 미국, 33756
        • Novartis Investigative Site
      • Ft. Walton Beach, Florida, 미국, 32547
        • Novartis Investigator Site
      • Miami, Florida, 미국, 33136
        • Novartis Investigative Site
      • Miami, Florida, 미국, 331577
        • Novartis Investigative Site
      • Naranja, Florida, 미국, 33032
        • Novartis Investigative Site
      • Pensacola, Florida, 미국, 32514
        • Novartis Investigator Site
      • Sarasota, Florida, 미국, 34233
        • Novartis Investigator Site
    • Georgia
      • Atlanta, Georgia, 미국, 30342
        • Novartis Investigative Site
      • Conyers, Georgia, 미국, 30094
        • Novartis Investigator Site
    • Illinois
      • Normal, Illinois, 미국, 61761
        • Novartis Investigative Site
    • Iowa
      • Iowa City, Iowa, 미국, 52240
        • Novartis Investigative Site
    • Kansas
      • Kansas City, Kansas, 미국, 66160
        • Novartis Investigative Site
      • Lenexa, Kansas, 미국, 66215
        • Novartis Investigative Site
      • Topeka, Kansas, 미국, 66606
        • Novartis Investigative Site
    • Louisiana
      • Lafayette, Louisiana, 미국, 70503
        • Novartis Investigator Site
      • Metaire, Louisiana, 미국, 70002
        • Novartis Investigator Site
      • New Orleans, Louisiana, 미국, 70119
        • Novartis Investigator Site
      • Slidell, Louisiana, 미국, 70458
        • Novartis Investigator Site
    • Maryland
      • Columbia, Maryland, 미국, 21044
        • Novartis Investigator Site
    • Massachusetts
      • Brockton, Massachusetts, 미국, 02301
        • Novartis Investigator Site
    • Michigan
      • Clarkston, Michigan, 미국, 48346
        • Novartis Investigator Site
      • Detroit, Michigan, 미국, 48202
        • Novartis Investigator Site
    • Missouri
      • St Charles, Missouri, 미국, 63301
        • Novartis Investigative Site
    • Montana
      • Missoula, Montana, 미국, 59808
        • Novartis Investigator Site
    • Nebraska
      • Boys Town, Nebraska, 미국, 68010
        • Novartis Investigator Site
      • Omaha, Nebraska, 미국, 68114
        • Novartis Investigative Site
      • Omaha, Nebraska, 미국, 68134
        • Novartis Investigative Site
    • Nevada
      • Las Vegas, Nevada, 미국, 89119
        • Novartis Investigative Site
    • New Hampshire
      • Lebanon, New Hampshire, 미국, 03756
        • Novartis Investigator Site
    • New Jersey
      • Asbury Park, New Jersey, 미국, 07712
        • Novartis Investigator Site
    • New York
      • Rochester, New York, 미국, 14618
        • Novartis Investigative Site
    • North Carolina
      • Mooresville, North Carolina, 미국, 28117
        • Novartis Investigator Site
      • Winston-Salem, North Carolina, 미국, 27103
        • Novartis Investigative Site
    • Oklahoma
      • Tulsa, Oklahoma, 미국, 74135-2920
        • Novartis Investigator Site
    • Oregon
      • Medford, Oregon, 미국, 97504
        • Novartis Investigative Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, 미국, 18020
        • Novartis Investigator Site
    • Rhode Island
      • Cumberland, Rhode Island, 미국, 02864
        • Novartis Investigative Site
    • South Carolina
      • Greenville, South Carolina, 미국, 29615
        • Novartis Investigator Site
      • Spartanburg, South Carolina, 미국, 29303
        • Novartis Investigative Site
    • Tennessee
      • Knoxville, Tennessee, 미국, 37919
        • Novartis Investigator Site
    • Texas
      • El Paso, Texas, 미국, 79903
        • Novartis Investigator Site
      • Houston, Texas, 미국, 77024
        • Novartis Investigative Site
      • Houston, Texas, 미국, 77079
        • Novartis Investigative Site
      • New Braunfels, Texas, 미국, 78130-6113
        • Novartis Investigative Center
    • Virginia
      • Newport News, Virginia, 미국, 23606
        • Novartis Investigator Site
      • Richmond, Virginia, 미국, 23225
        • Novartis Investigative Site
      • Richmond, Virginia, 미국, 23249
        • Novartis Investigator Site
  • 스페인
      • Alicante, 스페인
        • Novartis Investigative Site
      • Barcelona, 스페인
        • Novartis Investigator Site
      • Begonte, 스페인
        • Novartis Investigator Site
      • Cadiz, 스페인
        • Novartis Investigator Site
      • Granollers, 스페인
        • Novartis Investigator Site
      • Jaén, 스페인
        • Novartis Investigative Site
      • La Coruna, 스페인
        • Novartis Investigator Site
      • Leon, 스페인
        • Novartis Investigator Site
      • Madrid, 스페인
        • Novartis Investigator Site
      • Pamplona, 스페인
        • Novartis Investigator Site
      • Torrelavega, 스페인
        • Novartis Investigator Site
      • Valencia, 스페인
        • Novartis Investigator Site
      • Vigo, 스페인
        • Novartis Investigator Site
  • 아르헨티나
      • Buenos Aires, 아르헨티나
        • Novartis Investigative Site
      • Cordoba, 아르헨티나
        • Novartis Investigative Site
      • Corrientes, 아르헨티나
        • Novartis Investigative Site
      • Mendoza, 아르헨티나
        • Novartis Investigative Site
      • Rosario, 아르헨티나
        • Novartis Investigative Site
  • 칠면조
      • Antalya, 칠면조
        • Novartis Investigator Site
      • Canakkale, 칠면조
        • Novartis Investigator Site
      • Isparta, 칠면조
        • Novartis Investigator Site
      • Istanbul, 칠면조
        • Novartis Investigator Site
      • Kartal, 칠면조
        • Novartis Investigator Site
      • Kayseri, 칠면조
        • Novartis Investigator Site
      • Kozlu / Zonguldak, 칠면조
        • Novartis Investigator Site
      • Malatya, 칠면조
        • Novartis Investigator Site
      • Manisa, 칠면조
        • Novartis Investigator Site
      • Mecidiyekoy/Istanbul, 칠면조
        • Novartis Investigator Site
      • Yenisehir/Izmir, 칠면조
        • Novartis Investigator Site
  • 콜롬비아
      • Barranquilla, 콜롬비아
        • Novartis Investigative Site
      • Bogota, 콜롬비아
        • Novartis Investigative Site
      • Bogota, 콜롬비아
        • Novartis Investigator Site
      • Medellin, 콜롬비아
        • Novartis Investigative Site
  • 필리핀 제도
      • Manila, 필리핀 제도
        • Novartis Investigator Site
  • 호주
      • Box Hill, 호주
        • Novartis Investigator Site
      • Clayton, 호주
        • Novartis Investigator Site
      • Garran, 호주
        • Novartis Investigator Site
      • Glebe, 호주
        • Novartis Investigator Site
      • Kogarah, 호주
        • Novartis Investigator Site
      • Nedlands, 호주
        • Novartis Investigator 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

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) and:

    1. Smoking history of at least 10 pack-years
    2. Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30% of the predicted normal value
    3. Post-bronchodilator FEV1/FVC (force vital capacity) < 70%

Exclusion Criteria:

  • Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening or during the run-in period
  • Patients who have had a respiratory tract infection within 6 weeks prior to screening or during the run-in period
  • Patients with a body mass index less than 15 or more than 40 kg/m^2
  • Patients with concomitant pulmonary disease
  • Patients with a history of asthma
  • Patients with diabetes Type I or uncontrolled diabetes Type II
  • Any patient with lung cancer or a history of lung cancer
  • Patients with a history of certain cardiovascular comorbid conditions

Other protocol-defined inclusion/exclusion criteria applied to the study.

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: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Indacaterol 150 μg and tiotropium 18 μg
Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
의약품: Indacaterol 150 μg
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
의약품: Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).
활성 비교기: Tiotropium 18 μg
Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
의약품: Tiotropium 18 μg
Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).
의약품: Placebo to indacaterol
Placebo to indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12)
기간: From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84)

2차 결과 측정

결과 측정
측정값 설명
기간
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)
기간: 24 hours post-dose at the end of treatment (Week 12 + 1 day, Day 85)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study (Week 12 + 1 day, Day 85). The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
24 hours post-dose at the end of treatment (Week 12 + 1 day, Day 85)
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1
기간: From 5 minutes to 8 hours post-dose on Day 1
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
From 5 minutes to 8 hours post-dose on Day 1
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2
기간: 24 hours post-dose on Day 2
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
24 hours post-dose on Day 2
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1
기간: From 5 minutes to 4 hours post-dose on Day 1
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
From 5 minutes to 4 hours post-dose on Day 1
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)
기간: From 5 minutes to 4 hours post-dose at the end of treatment (Week 12)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of treatment (Week 12). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
From 5 minutes to 4 hours post-dose at the end of treatment (Week 12)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Novartis Pharmaceuticals

간행물 및 유용한 링크

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

일반 간행물

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

2009년 3월 1일

기본 완료 (실제)

2010년 3월 1일

연구 완료 (실제)

2010년 3월 1일

연구 등록 날짜

최초 제출

2009년 2월 15일

QC 기준을 충족하는 최초 제출

2009년 2월 15일

처음 게시됨 (추정)

2009년 2월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2011년 8월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2011년 7월 22일

마지막으로 확인됨

2011년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CQAB149B2341

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