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To Evaluate the Effect of Inhaled Medication Together With Exercise and Activity Training on Exercise Capacity and Daily Activities in Patients With Chronic Lung Disease With Obstruction of Airways

2016년 11월 9일 업데이트: Boehringer Ingelheim

An Exploratory, 12 Week, Randomised, Partially Double-blinded, Placebo-controlled Parallel Group Trial to Explore the Effects of Once Daily Treatments of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination or Tiotropium (Both Delivered by Respimat® Inhaler), Supervised Exercise Training and Behavior Modification on Exercise Capacity and Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The primary objectives of the study are to explore the effect of treatment with orally inhaled tiotropium + olodaterol fixed dose combination with and without exercise training, and tiotropium comparing to placebo, on top of behavioural modification in improving exercise capacity in patients with COPD

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

304

단계

  • 3단계

연락처 및 위치

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

연구 장소

  • 뉴질랜드
      • Greenlane East Auckland NZ, 뉴질랜드
        • Boehringer Ingelheim Investigational Site
  • 덴마크
      • Kolding, 덴마크
        • Boehringer Ingelheim Investigational Site
      • København NV, 덴마크
        • Boehringer Ingelheim Investigational Site
      • Odense, 덴마크
        • Boehringer Ingelheim Investigational Site
  • 독일
      • Berlin, 독일
        • Boehringer Ingelheim Investigational Site
      • Bochum, 독일
        • Boehringer Ingelheim Investigational Site
      • Frankfurt, 독일
        • Boehringer Ingelheim Investigational Site
      • Großhansdorf, 독일
        • Boehringer Ingelheim Investigational Site
      • Heidelberg, 독일
        • Boehringer Ingelheim Investigational Site
      • Leverkusen, 독일
        • Boehringer Ingelheim Investigational Site
      • Solingen, 독일
        • Boehringer Ingelheim Investigational Site
      • Teuchern, 독일
        • Boehringer Ingelheim Investigational Site
      • Tübingen, 독일
        • Boehringer Ingelheim Investigational Site
  • 미국
    • California
      • San Diego, California, 미국
        • Boehringer Ingelheim Investigational Site
      • Torrance, California, 미국
        • Boehringer Ingelheim Investigational Site
    • Connecticut
      • Hartford, Connecticut, 미국
        • Boehringer Ingelheim Investigational Site
  • 벨기에
      • Genk, 벨기에
        • Boehringer Ingelheim Investigational Site
      • Hasselt, 벨기에
        • Boehringer Ingelheim Investigational Site
      • Leuven, 벨기에
        • Boehringer Ingelheim Investigational Site
  • 영국
      • Leicester, 영국
        • Boehringer Ingelheim Investigational Site
      • Norwich, 영국
        • Boehringer Ingelheim Investigational Site
      • Sheffield, 영국
        • Boehringer Ingelheim Investigational Site
  • 오스트리아
      • Salzburg, 오스트리아
        • Boehringer Ingelheim Investigational Site
  • 캐나다
    • Quebec
      • Montreal, Quebec, 캐나다
        • Boehringer Ingelheim Investigational Site
      • Ste-Foy, Quebec, 캐나다
        • Boehringer Ingelheim Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, 캐나다
        • Boehringer Ingelheim Investigational Site
  • 포르투갈
      • Coimbra, 포르투갈
        • Boehringer Ingelheim Investigational Site
      • Lisboa, 포르투갈
        • Boehringer Ingelheim Investigational Site
      • Porto, 포르투갈
        • Boehringer Ingelheim Investigational Site
  • 폴란드
      • Gdansk, 폴란드
        • Boehringer Ingelheim Investigational Site
      • Lodz, 폴란드
        • Boehringer Ingelheim Investigational Site
      • Starachowice, 폴란드
        • Boehringer Ingelheim Investigational Site
  • 호주
    • South Australia
      • Daw Park, South Australia, 호주
        • Boehringer Ingelheim Investigational Site
      • Glen Osmond, South Australia, 호주
        • 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 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion criteria:

  • All patients must sign an informed consent consistent with International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
  • All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a post-bronchodilator forced expiratory volume in one second >=30% and <80% of predicted normal; Global Initiative for Chronic Obstructive Lung Disease grade II - III, and a post-bronchodilator Tiffeneau index <70% at Visit 1.
  • Male or female patients, aged >=40 years and <=75 years.
  • Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.

Exclusion criteria:

  • Patients with a significant disease other than chronic obstructive pulmonary disease.
  • Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis.
  • Patients with a history of asthma.
  • A diagnosis of thyrotoxicosis.
  • A diagnosis of paroxysmal tachycardia (>100 beats per minute).
  • A history of myocardial infarction within 1 year of screening visit.
  • Unstable or life-threatening cardiac arrhythmia.
  • Hospitalized for heart failure within the past year.
  • Known active tuberculosis.
  • A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years.
  • A history of life-threatening pulmonary obstruction and patients with chronic respiratory failure.
  • A history of cystic fibrosis.
  • Clinically evident bronchiectasis.
  • A history of significant alcohol or drug abuse.
  • Any contraindications for exercise testing.
  • Patients who have undergone thoracotomy with pulmonary resection.
  • Patients being treated with any oral ß-adrenergics.
  • Patients being treated with oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
  • Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigators opinion will be unable to abstain from the use of oxygen therapy during clinic visits.
  • Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program.
  • Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris or claudication or morbid obesity.
  • Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit.
  • Patients with known hypersensitivity to ß-adrenergics drugs, anticholinergic drugs, benzalkonium chloride, disodium edentat, or any other component of the Respimat® inhalation solution delivery system.
  • Pregnant or nursing women.
  • Women of childbearing potential not using highly effective methods of birth control.
  • Patients who have previously been randomized in this study or are currently participating in another 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: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: placebo
patient will receive placebo once daily, 2 puffs in the morning
의약품: placebo to tiotropium + olodaterol
comparator
실험적: tiotropium + olodaterol high dose with BM
patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily, 2 puffs in the morning
의약품: tiotropium +olodaterol
olodaterol 5 mcg once daily fixed dose combination
활성 비교기: tiotropium
patient will receive tiotropium 5 mcg once daily, 2 puffs in the morning
의약품: tiotropium
tiotropium 5 mcg once daily fixed dose combination
실험적: tiotropium + olodaterol with exercise training and BM
patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily, 2 puffs in the morning
의약품: tiotropium+olodaterol
tiotropium 5 mcg once daily

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 8 Weeks
기간: Week 8
Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption (VO2 peak) after 8 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then an analysis of covariance (ANCOVA) was fitted to the log10-transformed data and the least square means (LSMean) and standard error (SE) were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean.
Week 8

2차 결과 측정

결과 측정
측정값 설명
기간
Average Daily Walking Time Measured by the Activity Monitor in the Week Prior to Week 12
기간: Week 12
Average daily walking time measured by the activity monitor in the week prior to Week 12.
Week 12
Average Daily Walking Intensity Measured by the Activity Monitor in the Week Prior to 12 Weeks of Treatment
기간: Week 12
Average daily walking intensity measured by the activity monitor in the week prior to 12 weeks of treatment. The Movement Intensity (MI) is derived from the acceleration signals. Since seismic sensors measure gravitational acceleration (g) in static situations, the acceleration signal is expressed relative to g (1g = 9.81m/s2). To calculate movement intensity (MI) the gravitational acceleration in static situations was removed and the rotation vector of the three accelerometer signals was calculated. The MI gives an indication of the power of movements.
Week 12
Perceived Difficulties as Evaluated With Functional Performance Inventory-Short Form (FPI-SF) Total Score at Week 12
기간: Week 12
Perceived difficulties as evaluated with FPI-SF. FPI-SF self-report questionnaire has 6 domains: Body care(5 items), Household maintenance(8 items), Physical exercise(5 items), Recreation(5 items), Spiritual activities(4 items) and Social interaction(5 items) with five possible answers on each item: Do with no difficulty - 3, Do with some difficulty - 2, Do with great difficulty - 1, don't do because of health reasons - 0, and don't do because choose not to - 0. Domain scores are expressed as mean values, with at least 6 non-missing items required for the household maintenance domain and at least 3 non-missing items for the other domains. Total score is the mean across the six domains. So total and domain scores range from 0 to 3, with higher scores indicating higher levels of functional activity within and across domains. Respondents engaged in many activities with no difficulty will score high on the FPI, while those who perform few activities with much difficulty will score low.
Week 12
Endurance Time During Endurance Shuttle Walk Test (ESWT) to Symptom Limitation After 12 Weeks
기간: Week 12
Endurance time during ESWT to symptom limitation at walking speed corresponding to 85% of maximum oxygen consumption (VO2 peak) after 12 weeks of pharmacological treatment and non-pharmacological intervention. The numerical value of endurance time in seconds was transformed in log10 scale to correct for skewness and then the ANCOVA was fitted to the log10-transformed data and the least square means and SE were obtained. To present the results in a way easier for interpretation, the least square mean from the ANCOVA fitted to the log10-transformed data were transformed back taking 10 to the power of the least square estimate to obtain the geometric mean and the corresponding SE was transformed using delta method to get the corresponding SE of the geometric mean.
Week 12
One Hour, Post-dose Forced Expiratory Volume in One Second (FEV1) After 8 Weeks of Treatment
기간: Week 8
One hour, Post-dose Forced Expiratory Volume in One Second (FEV1) after 8 weeks of treatment.
Week 8
One Hour, Post-dose Forced Vital Capacity (FVC) After 8 Weeks of Treatment
기간: Week 8
One hour, Post-dose Forced Vital Capacity (FVC) after 8 weeks of treatment.
Week 8
Resting Inspiratory Capacity (IC) Measured at 1.5 Hours Post Dose After 8 Weeks of Treatment
기간: Week 8
Resting inspiratory capacity (IC) measured at 1.5 hours post dose after 8 weeks of treatment.
Week 8

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

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.

일반 간행물

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

2014년 3월 1일

기본 완료 (실제)

2015년 8월 1일

연구 완료 (실제)

2015년 10월 1일

연구 등록 날짜

최초 제출

2014년 3월 7일

QC 기준을 충족하는 최초 제출

2014년 3월 7일

처음 게시됨 (추정)

2014년 3월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2017년 1월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 11월 9일

마지막으로 확인됨

2016년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 1237.16
  • 2013-002671-18 (EudraCT 번호: 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. .

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