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Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma

2015년 1월 15일 업데이트: Novartis Pharmaceuticals

A Multicenter, Randomized, Double-blind, Placebo-controlled, 12-week Treatment, Parallel-group Study to Assess the Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate (75 and 150 µg o.d.) in Patients With Persistent Asthma

To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.

연구 개요

연구 유형

중재적

등록 (실제)

335

단계

  • 2 단계

연락처 및 위치

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

연구 장소

      • Rotterdam, 네덜란드, 3045 PM
        • Novartis Investigative Site
      • Sittard-Geleen, 네덜란드, 6162 BG
        • Novartis Investigative Site
      • Seoul, 대한민국, 120-752
        • Novartis Investigative Site
      • Seoul, 대한민국, 158-710
        • Novartis Investigative Site
      • Seoul, 대한민국, 152-703
        • Novartis Investigative Site
      • Seoul, 대한민국, 100-032
        • Novartis Investigative Site
    • Chungbuk
      • Cheongju, Chungbuk, 대한민국, 361 711
        • Novartis Investigative Site
    • Gangwon-Do
      • Wonju, Gangwon-Do, 대한민국, 220-701
        • Novartis Investigative Site
    • Korea
      • Seoul, Korea, 대한민국, 110 744
        • Novartis Investigative Site
      • Bad Woerishofen, 독일, 86825
        • Novartis Investigative Site
      • Bonn, 독일, 53123
        • Novartis Investigative Site
      • Dortmund, 독일, 44263
        • Novartis Investigative Site
      • Dresden, 독일, 01307
        • Novartis Investigative Site
      • Frankfurt, 독일, 60596
        • Novartis Investigative Site
      • Lübeck, 독일, 23552
        • Novartis Investigative Site
      • Mainz, 독일, 55131
        • Novartis Investigative Site
      • Muenchen, 독일, 81677
        • Novartis Investigative Site
      • Wiesbaden, 독일, 65187
        • Novartis Investigative Site
      • Wiesloch, 독일, 69168
        • Novartis Investigative Site
      • Lovech, 불가리아, 5500
        • Novartis Investigative Site
      • Pleven, 불가리아, 5800
        • Novartis Investigative Site
      • Plovdiv, 불가리아, 4002
        • Novartis Investigative Site
      • Ruse, 불가리아, 7002
        • Novartis Investigative Site
      • Sofia, 불가리아, 1431
        • Novartis Investigative Site
      • Sofia, 불가리아, 1233
        • Novartis Investigative Site
      • Sofia, 불가리아, 1606
        • Novartis Investigative Site
      • Sofia, 불가리아, 1612
        • Novartis Investigative Site
      • Sofia, 불가리아, 1000
        • Novartis Investigative Site
      • Sofia, 불가리아, 1234
        • Novartis Investigative Site
      • Sofia, 불가리아, 1463
        • Novartis Investigative Site
      • Varna, 불가리아, 9000
        • Novartis Investigative Site
      • Varna, 불가리아, 9020
        • Novartis Investigative Site
      • Veliko Tarnovo, 불가리아, 5000
        • Novartis Investigative Site
      • Dunajska Streda, 슬로바키아, 929 01
        • Novartis Investigative Site
      • Komarno, 슬로바키아, 945 01
        • Novartis Investigative Site
      • Kosice, 슬로바키아, 040 01
        • Novartis Investigative Site
      • Liptovsky Hradok, 슬로바키아, 033 01
        • Novartis Investigative Site
      • Liptovsky Mikulas, 슬로바키아, 031 23
        • Novartis Investigative Site
      • Nove Zamky, 슬로바키아, 940 01
        • Novartis Investigative Site
      • Rimavska Sobota, 슬로바키아, 979 01
        • Novartis Investigative Site
      • Spisská Nová Ves, 슬로바키아, 052 01
        • Novartis Investigative Site
      • Topolcany, 슬로바키아, 955 01
        • Novartis Investigative Site
      • Vysne Hagy, 슬로바키아, 5984
        • Novartis Investigative Site
      • Zvolen, 슬로바키아, 960 01
        • Novartis Investigative Site
    • Slovak Republic
      • Banska Bystrica, Slovak Republic, 슬로바키아, 975 17
        • Novartis Investigative Site
      • Bardejov, Slovak Republic, 슬로바키아, 085 01
        • Novartis Investigative Site
    • Slovak republic
      • Levice, Slovak republic, 슬로바키아, 934 01
        • Novartis Investigative Site
      • Fukuoka, 일본, 811-1394
        • Novartis Investigative Site
      • Gifu, 일본, 502-8558
        • Novartis Investigative Site
    • Fukuoka
      • Yanagawa, Fukuoka, 일본, 832-0059
        • Novartis Investigative Site
    • Hokkaido
      • Obihiro, Hokkaido, 일본, 080-0805
        • Novartis Investigative Site
      • Sapporo-city, Hokkaido, 일본, 060-0061
        • Novartis Investigative Site
    • Hyogo
      • Himeji-city, Hyogo, 일본, 672-8064
        • Novartis Investigative Site
    • Hyogo-Ken
      • Ako-shi, Hyogo-Ken, 일본, 678-0241
        • Novartis Investigative Site
    • Ibaraki
      • Naka-gun, Ibaraki, 일본, 319-1113
        • Novartis Investigative Site
    • Kagawa
      • Sakaide, Kagawa, 일본, 762-0031
        • Novartis Investigative Site
    • Kyoto-Fu
      • Kyoto-shi, Kyoto-Fu, 일본, 615-8256
        • Novartis Investigative Site
    • Mie
      • Tsu, Mie, 일본, 514-1101
        • Novartis Investigative Site
    • Oita
      • Beppu, Oita, 일본, 874-0937
        • Novartis Investigative Site
    • Oita-Ken
      • Oita-shi, Oita-Ken, 일본, 870-0021
        • Novartis Investigative Site
    • Osaka
      • Kishiwada, Osaka, 일본, 596-8501
        • Novartis Investigative Site
    • Tokyo
      • Chuo-ku, Tokyo, 일본, 103-0027
        • Novartis Investigative Site
      • Cyuo-ku, Tokyo, 일본, 104-8560
        • Novartis Investigative Site
      • Itabashi-ku, Tokyo, 일본, 173-8610
        • Novartis Investigative Site
      • Kiyose-city, Tokyo, 일본, 204-8585
        • Novartis Investigative Site
      • Setagaya-ku, Tokyo, 일본, 158-0097
        • Novartis Investigative Site
    • Tokyo-To
      • Machida-shi, Tokyo-To, 일본, 194-0023
        • Novartis Investigative Site
      • Ota-ku, Tokyo-To, 일본, 144-0035
        • Novartis Investigative Site
    • Yamagata
      • Yonezawa, Yamagata, 일본, 992-0045
        • Novartis Investigative Site
    • Ontario
      • Brampton, Ontario, 캐나다, L6T 0G1
        • Novartis Investigative Site
      • Downsview, Ontario, 캐나다, M3N 2Z9
        • Novartis Investigative Site
      • Etobicoke, Ontario, 캐나다, M9V 4B4
        • Novartis Investigative Site
      • Grimsby, Ontario, 캐나다, L3M 1P3
        • Novartis Investigative Site
      • Hamilton, Ontario, 캐나다, L8N 3Z5
        • Novartis Investigative Site
      • Newmarket, Ontario, 캐나다, L3Y 5G8
        • Novartis Investigative Site
      • Toronto, Ontario, 캐나다, M5T 3A9
        • Novartis Investigative Site
      • Woodstock, Ontario, 캐나다, N4S 5P5
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, 캐나다, H4J 1C5
        • Novartis Investigative Site
      • Pointe-Claire, Quebec, 캐나다, H9R 4S3
        • Novartis Investigative Site
      • St-Romuald, Quebec, 캐나다, G6W 5M6
        • Novartis Investigative Site
      • Ste-Foy, Quebec, 캐나다, G1W 4R4
        • Novartis Investigative Site
      • Bialystok, 폴란드, 15-461
        • Novartis Investigative Site
      • Bienkowka, 폴란드, 34-212
        • Novartis Investigative Site
      • Bydgoszcz, 폴란드, 85-046
        • Novartis Investigative Site
      • Gdansk, 폴란드, 80-958
        • Novartis Investigative Site
      • Krakow, 폴란드, 31-023
        • Novartis Investigative Site
      • Lodz, 폴란드, 90-302
        • Novartis Investigative Site
      • Lodz, 폴란드, 90-242
        • Novartis Investigative Site
      • Lublin, 폴란드, 20-637
        • Novartis Investigative Site
      • Lublin, 폴란드, 20-044
        • Novartis Investigative Site
      • Torun, 폴란드, 87-100
        • Novartis Investigative Site
      • Wroclaw, 폴란드, 50-088
        • Novartis Investigative Site
      • Znin, 폴란드, 88-400
        • Novartis Investigative 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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:
  • Patients who are receiving ICS treatment in a stable regimen for ≥ 4 weeks
  • Patients with a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% of predicted normal value
  • Patients who demonstrate an increase of >= 12% and 200 mL in FEV1
  • ACQ-5 score ≥ 1.5

Exclusion Criteria:

  • Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
  • Patients with chronic lung disease, including COPD, pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disease and cystic fibrosis.
  • Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.

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: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: indacaterol acetate 75 µg

indacaterol acetate 75 µg od delivered via Concept 1 inhaler

Background therapy: mometasone furoate 200 mcg od

indacaterol acetate 75 µg or indacaterol acetate 150 µg delivered via Concept 1 inhaler
via Twisthaler inhaler
실험적: indacaterol acetate 150 µg

indacaterol acetate 150 µg od delivered via Concept 1 inhaler

Background therapy: mometasone furoate 200 mcg od

indacaterol acetate 75 µg or indacaterol acetate 150 µg delivered via Concept 1 inhaler
via Twisthaler inhaler
위약 비교기: placebo

placebo delivered via Concept 1 inhaler

Background therapy: mometasone furoate 200 mcg od

via Twisthaler inhaler
placebo delivered via Concept 1 inhaler

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)
기간: after 12 weeks (Day 85)
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 12 weeks (Day 85)
after 12 weeks (Day 85)

2차 결과 측정

결과 측정
측정값 설명
기간
Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)
기간: aftert 12 weeks (Day 85)
The Asthma Control Questionnaire (ACQ-5) is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.
aftert 12 weeks (Day 85)
Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.
기간: Day 15, Day 29 and Day 57
Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose after 2 weeks (Day 15), 4 weeks (Day 29), and 8 weeks (Day 57) of treatment.
Day 15, Day 29 and Day 57
Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points
기간: Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. FVC is measured on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at all time points
Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
기간: Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards.
Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
기간: Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
Forced Expiratory Flow (FEF 25-75%) was measured via spirometry conducted according to internationally accepted standards.
Day 1, Day 2, Day 14, Day 15, Day 84, Day 85
Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)
기간: Day 1, 2 Weeks, 12 Weeks
Forced Expiratory Volume in 1 second (FEV1)/Area Under the Curve(AUC) was measured via spirometry conducted according to internationally accepted standards.FEV1 AUC(5 min - 4 h), (5 min - 1 h) and (1 h - 4 h) are measured at Day 1, 2 Weeks (Day 14) and 12 Weeks (Day84) and defined as average of FEV1 at specified timepoints above.
Day 1, 2 Weeks, 12 Weeks
Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)
기간: Day 1, 2 weeks (Day 14), 12 weeks (Day 84)
Peak Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Peak FEV1 is defined as the maximum FEV1 during the first 4 h post morning dosing at Day 1, 2Weeks and 12 Weeks.
Day 1, 2 weeks (Day 14), 12 weeks (Day 84)
Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment
기간: after 4 weeks (Day 29) and after 8 weeks (Day 57)
The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze. Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).
after 4 weeks (Day 29) and after 8 weeks (Day 57)
Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.
기간: baseline, 4weeks, 8 weeks and 12 weeks
PEFR is measured with portable spirometer by participants every morning and evening at home.
baseline, 4weeks, 8 weeks and 12 weeks
The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment
기간: 12 weeks
Participants record the number of puffs of rescue medication taken in the previous 12 hours in the morning and nighttime.
12 weeks
Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment
기간: 4 Weeks, 12 Weeks
The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma. Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks. The overall AQLQ score is the mean response to all 32 questions. Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1. Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.
4 Weeks, 12 Weeks
Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
기간: 12 weeks
Duration of treatment until first asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is systemic corticosteroids (SCS) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
12 weeks
The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
기간: 12 weeks
Annual incidence rate of asthma exacerbation by severity of exacerbation. The number of asthma exacerbation is used to calculate annual incidence rate. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations. Number of the asthma exacerbation will be analyzed by the negative binomial regression including treatment, history of asthma exacerbation in the 12 months prior to screening and region as factors and FEV1 prior to inhalation and FEV1 30 min post inhalation of salbutamol/albuterol (components of SABA reversibility) as covariates. The estimates are obtained from the model and so we cannot specify a formula.
12 weeks
Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
기간: 12 weeks
Duration of asthma exacerbations by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
12 weeks
The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period
기간: 12 weeks
The percentage of patients with at least one asthma exacerbation by severity of exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
12 weeks
Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period
기간: 12 weeks
Time to permanent study discontinuation due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
12 weeks
The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period
기간: 12 weeks
The percentage of patients who permanently discontinued study due to asthma exacerbation. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
12 weeks
Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period
기간: 12 weeks
Total amounts (in doses) of systemic corticosteroids (SCS) used to treat asthma exacerbations.SCS includes Intramuscular (IM), Intravenous (IV) and Oral. A severe asthma exacerbation is SCS use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma. A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h). Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations.
12 weeks
Plasma Indacaterol Concentrations at Day 1 and Day 14
기간: Day 1 and Day 14
Maximum plasma concentration after drug administration (Cmax) was measured for indacaterol acetate 75 µg and indacaterol acetate 150 µg for Pharmacokinetic (PK) Subgroup
Day 1 and Day 14

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 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

2012년 8월 1일

기본 완료 (실제)

2013년 7월 1일

연구 완료 (실제)

2013년 7월 1일

연구 등록 날짜

최초 제출

2012년 4월 23일

QC 기준을 충족하는 최초 제출

2012년 5월 29일

처음 게시됨 (추정)

2012년 6월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 1월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 1월 15일

마지막으로 확인됨

2015년 1월 1일

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