- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01012765
Effect of Indacaterol on Inspiratory Capacity (IC)
2016년 2월 16일 업데이트: Novartis Pharmaceuticals
A Randomized, Double-blind, Placebo Controlled, Multicenter, 3-period Crossover Study to Compare the Effect of Indacaterol (150μg o.d.) on Inspiratory Capacity to Placebo in Patients With Moderate COPD, Using Open Label Tiotropium (18μg o.d.) as Active Control
This study is being conducted to assess the effect of indacaterol (150 μg o.d.) on inspiratory capacity (IC), using placebo and open label tiotropium (18 μg o.d.) as comparators in patients with moderate chronic obstructive pulmonary disease (COPD).
In particular, spirometric timepoints are included to elucidate the peak-IC in a period of approximately 4 hour post inhalation
연구 개요
연구 유형
중재적
등록 (실제)
173
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Aschaffenburg, 독일
- Novartis Investigative Site
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Berlin, 독일
- Novartis Investigative Site
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Dresden, 독일
- Novartis Investigative Site
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Erfurt, 독일
- Novartis Investigative Site
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Frankfurt am Main, 독일
- Novartis Investigative Site
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Fulda, 독일
- Novartis Investigative Site
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Geesthacht, 독일
- Novartis Investigative Site
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Großhansdorf, 독일
- Novartis Investigative Site
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Halle, 독일
- Novartis Investigative Site
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Hamburg, 독일
- Novartis Investigative Site
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Kiel, 독일
- Novartis Investigative Site
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Koblenz, 독일
- Novartis Investigative Site
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Leipzig, 독일
- Novartis Investigative Site
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Mannheim, 독일
- Novartis Investigative Site
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Marburg, 독일
- Novartis Investigative Site
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Neumünster, 독일
- Novartis Investigative Site
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Potsdam, 독일
- Novartis Investigative Site
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Rathenow, 독일
- Novartis Investigative Site
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Rüdersdorf, 독일
- Novartis Investigative Site
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Witten, 독일
- Novartis Investigator Site
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Zerbst, 독일
- Novartis Investigative Site
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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:
Co-operative outpatients with a diagnosis of COPD (moderate as classified by the GOLD Guidelines, 2008) and including:
- Smoking history of at least 10 pack years
- Post-bronchodilator FEV1 <80% and ≥50% of the predicted normal value (Visit 2).
- Post-bronchodilator FEV1/forced vital capacity (FVC) <70% (Visit 2).
Exclusion Criteria:
- Patients who received any corticosteroid (including inhaled) for 3 months prior to screening
Other protocol-defined inclusion/exclusion criteria may apply
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: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Indacaterol - placebo - tiotropium
In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received tiotropium 18µg once daily.
Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device.
There was a washout period of 13 days between each period.
Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued.
Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium 18µg o.d.
delivered via a proprietary inhalation device.
Placebo to indacaterol o.d.
delivered via SDDPI
|
실험적: Placebo - Tiotropium - Indacaterol
In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received tiotropium 18µg once daily; in treatment period 3, patients received indacaterol 150µg once daily.
Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device.
There was a washout period of 13 days between each period.
Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued.
Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium 18µg o.d.
delivered via a proprietary inhalation device.
Placebo to indacaterol o.d.
delivered via SDDPI
|
실험적: Tiotropium - indacaterol - placebo
In treatment period 1, patients received tiotropium 18µg once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received placebo to indacaterol once daily.
Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device.
There was a washout period of 13 days between each period.
Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued.
Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium 18µg o.d.
delivered via a proprietary inhalation device.
Placebo to indacaterol o.d.
delivered via SDDPI
|
실험적: Placebo - indacaterol - tiotropium
In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received tiotropium 18µg once daily.
Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device.
There was a washout period of 13 days between each period.
Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued.
Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium 18µg o.d.
delivered via a proprietary inhalation device.
Placebo to indacaterol o.d.
delivered via SDDPI
|
실험적: Indacaterol - tiotropium - placebo
In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received tiotropium 18µg once daily; in treatment period 3, patients received placebo to indacaterol once daily.
Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device.
There was a washout period of 13 days between each period.
Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued.
Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium 18µg o.d.
delivered via a proprietary inhalation device.
Placebo to indacaterol o.d.
delivered via SDDPI
|
실험적: Tiotropium - placebo - indacaterol
In treatment period 1, patients received tiotropium 18µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received indacaterol 150µg once daily.
Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device.
There was a washout period of 13 days between each period.
Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued.
Salbutamol rescue use was allowed during the treatment period as needed.
|
Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI)
Tiotropium 18µg o.d.
delivered via a proprietary inhalation device.
Placebo to indacaterol o.d.
delivered via SDDPI
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Peak Inspiratory Capacity (IC) After 21 Days of Treatment
기간: 21 days
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IC was measured with spirometry conducted according to internationally accepted standards.
Peak IC was defined as the maximum IC of the mean over the 3 values which were measured each at 30min, 2 hour, 3 hour and 4 hour post dose by body plethysmography.
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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21 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Trough IC After 20 Days of Treatment
기간: 20 days
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Trough IC was measured with spirometry conducted according to internationally accepted standards.
Trough IC was calculated as the mean of the three measurements of pre-dose body plethysmography (days 21, 55 and 89).
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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20 days
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Peak Residual Volume (RV) After 21 Days of Treatment
기간: 21 days
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Peak RV was measured with spirometry conducted according to internationally accepted standards.
Peak RV was calculated as the Total Lung Capacity minus the maximum of the three Inspiratory Vital Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89).
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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21 days
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Peak Total Lung Capacity (TLC) After 21 Days of Treatment
기간: 21 days
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TLC was measured with spirometry conducted according to internationally accepted standards.
Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89).
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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21 days
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Peak Residual Volume/Peak Total Lung Capacity (RV/TLC) Ratio After 21 Days of Treatment
기간: 21 days
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Peak RV/TLC ratio was measured with spirometry conducted according to internationally accepted standards.
Peak RV/TLC was defined as the peak RV/peak TLC.
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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21 days
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Peak Specific Airway Resistance (sRaw) After 21 Days of Treatment
기간: 21 days
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Peak sRaw was measured with spirometry conducted according to internationally accepted standards.
Peak sRaw was the mean of the three measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89).
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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21 days
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FEV1 30 Minutes Post-dose After 21 Days of Treatment
기간: 21 days
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FEV1 was measured with spirometry conducted according to internationally accepted standards.
FEV1 was measured 30 minutes post-dose.
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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21 days
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Trough Forced Expiratory Volume in 1 Second (FEV1) After 20 Days of Treatment
기간: 20 days
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FEV1 was measured with spirometry conducted according to internationally accepted standards.
FEV1 was measured pre-dose after 20 days of treatment.
Analysis of variance model was used with the factors: center, period, treatment, and patients within center.
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20 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
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 11월 1일
기본 완료 (실제)
2011년 1월 1일
연구 등록 날짜
최초 제출
2009년 11월 11일
QC 기준을 충족하는 최초 제출
2009년 11월 12일
처음 게시됨 (추정)
2009년 11월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 2월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 2월 16일
마지막으로 확인됨
2016년 2월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CQAB149BDE01
- EUDRACT No.: 2009-013686-26 (기타 식별자: EUDRACT)
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. .
Indacaterol에 대한 임상 시험
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Novartis Pharmaceuticals완전한
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Orion Corporation, Orion Pharma완전한
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Novartis Pharmaceuticals완전한
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Jiangsu HengRui Medicine Co., Ltd.모병
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Mundipharma Research Limited종료됨ACOS(고정 기류 방해 및 상승된 호산구)슬로바키아