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Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult and Pediatric Patients

2013년 10월 30일 업데이트: Boehringer Ingelheim

A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult (75 mg, 150 mg) and Pediatric (75 mg) Cystic Fibrosis Patients

The purpose of this study is to determine the effect of 24 weeks of treatment with BIIL 284 BS compared with placebo on pulmonary function and incidence of pulmonary exacerbation in adult and pediatric cystic fibrosis patients.

연구 개요

상태

종료됨

정황

낭포성 섬유증

개입 / 치료

의약품: BIIL 283 BS (Amelubent)

연구 유형

중재적

등록

420

단계

2 단계

연락처 및 위치

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

연구 장소

미국
- Arizona
  - Tucson, Arizona, 미국, 85724-5073
    - University of Arizona
- Arkansas
  - Little Rock, Arkansas, 미국, 72205
    - University of Arkansas for Medical Sciences
- California
  - Los Angeles, California, 미국, 90027
    - Children's Hospital of Los Angeles
  - Palo Alto, California, 미국, 94304-5786
    - Stanford University Medical Center
  - San Diego, California, 미국, 92128-4284
    - Children's Hospital & Health Center
  - San Francisco, California, 미국, 94143-0106
    - University of California at San Francisco
- Colorado
  - Denver, Colorado, 미국, 80262
    - University of Colorado
- Florida
  - Orlando, Florida, 미국, 32801
    - The Nemours Children's Clinic
  - St. Petersburg, Florida, 미국, 33701
    - Pediatric Pulmonary Associates, PA
- Illinois
  - Chicago, Illinois, 미국, 60614
    - Children's Memorial Hospital
  - Maywood, Illinois, 미국, 60153-3333
    - Loyola University Medical Center
- Indiana
  - Indianapolis, Indiana, 미국, 46202-5225
    - Riley Hospital
- Iowa
  - Iowa City, Iowa, 미국, 52242
    - University of Iowa Hospitals and Clinics
- Kentucky
  - Lexington, Kentucky, 미국, 40536-0284
    - University of Kentucky
- Louisiana
  - New Orleans, Louisiana, 미국, 70112
    - Tulane University
- Massachusetts
  - Boston, Massachusetts, 미국, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, 미국, 02115
    - Children's Hospital
- Michigan
  - Ann Arbor, Michigan, 미국, 48109-0212
    - University of Michigan Health System
- Minnesota
  - Minneapolis, Minnesota, 미국, 55455
    - University of Minnesota
- Missouri
  - St. Louis, Missouri, 미국, 63110
    - Washington University-St. Louis Children's Hospital
- Nebraska
  - Omaha, Nebraska, 미국, 68198-5190
    - University of Nebraska
- New York
  - Albany, New York, 미국, 12208
    - Albany Medical College
  - Rochester, New York, 미국, 14642
    - University of Rochester
- North Carolina
  - Chapel Hill, North Carolina, 미국, 27599-7220
    - University of North Carolina
- Ohio
  - Akron, Ohio, 미국, 44308-1062
    - Children's Hospital Medical Center of Akron
  - Cincinnati, Ohio, 미국, 45229-3039
    - Children's Hospital Medical Center
  - Cleveland, Ohio, 미국, 44106
    - Rainbow Babies & Children's Hospital
  - Columbus, Ohio, 미국, 45205
    - Columbus Children's Hospital
- Pennsylvania
  - Philadelphia, Pennsylvania, 미국, 19134
    - St. Christopher's Hospital for Children
  - Philadelphia, Pennsylvania, 미국, 19129
    - MCP Hospital
  - Pittsburgh, Pennsylvania, 미국, 15213
    - Children's Hospital of Pittsburgh
- Tennessee
  - Nashville, Tennessee, 미국, 37232-2586
    - Vanderbilt Children's Hospital
- Texas
  - Dallas, Texas, 미국, 75235
    - Children's Memorial Center of Dallas
  - Houston, Texas, 미국, 77030
    - Texas Children's Hospital
- Wisconsin
  - Madison, Wisconsin, 미국, 53792
    - University of Wisconsin Hospitals & Clinics

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

6년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

INCLUSION CRITERIA:

Male or female patients >= 6 years pediatric 6-17 years inclusive; adult >= 18 years)
Body weight >= 20 kg (determined at Visit 1)
Confirmed diagnosis of CF
Able to perform acceptable spirometric maneuvers, according to American Thoracic Society standards .
FEV1 25-85% predicted
Clinically stable
The patient or the patient's legally acceptable representative must be able to give informed consent.
The patient must be able to swallow the BIIL 284 BS tablets whole.
Patients taking a chronic medication must be willing to continue this therapy for the entire duration of the study.

EXCLUSION CRITERIA:

Patients with a significant history of allergy/hypersensitivity (including medication allergy) which is deemed relevant to the trial as judged by the Investigator. "Relevance" in this context refers to any increased risk of hypersensitivity reaction to trial medication; there are no specific issues of concern currently identified with respect to use of BIIL 284 BS in allergic patients per se.
Patients who have participated in another study with an Investigational drug within one month or 6 half-lives (whichever is greater) preceding the screening visit.
Patients with known relevant substance abuse, including alcohol or drug abuse.
Female patients who are pregnant or lactating, including females who have a positive serum pregnancy test at screening (pregnancy tests will be performed for all females of child bearing potential).
Female patients of child bearing potential who are not using a medically approved form of contraception.
Patients who are unable to comply with food requirements prior to dosing.
Patients with documented persistent colonization with Burkholderia cepacia.
Patients chronically using oral corticosteroids or high-dose ibuprofen.
Patients with hemoglobin < 9.0 g/dL; platelets < 100x10 to the 9th power/L; SGOT (ALT) or SGPT (AST) > 2.5 times the upper limit of normal; creatinine > 1.5 times upper limit normal.
Clinically significant disease or medical condition other than Cystic Fibrosis or Cystic Fibrosis-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	기간
Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) (percent predicted) 기간: 28 weeks	28 weeks
Proportion of patients with at least one pulmonary exacerbation during the treatment period as per definition of Fuchs et al 기간: 28 weeks	28 weeks

2차 결과 측정

결과 측정	기간
Change from baseline in post-bronchodilator forced vital capacity (FVC) percent predicted 기간: 28 weeks	28 weeks
Change from baseline in post-bronchodilator mean forced expiratory flow during the middle half of the FVC (FEF25-75% ) percent predicted 기간: 28 weeks	28 weeks
Change from baseline in post-bronchodilator maximal expiratory flow when 50% of FVC remains in lung (MEF50% )percent predicted 기간: 28 weeks	28 weeks
Change from baseline in post-bronchodilator maximal expiratory flow when 25% of FVC remains in lung (MEF25%) percent predicted 기간: 28 weeks	28 weeks
Change from baseline in post-bronchodilator inspiratory capacity (IC) 기간: 28 weeks	28 weeks
Change from baseline in post-bronchodilator slow vital capacity (SVC) 기간: 28 weeks	28 weeks
Change from baseline in pre-bronchodilator FEV1% predicted 기간: week 12, 24 and 28	week 12, 24 and 28
Change from baseline in pre-bronchodilator FVC % predicted 기간: week 12, 24 and 28	week 12, 24 and 28
Change from baseline in pre-bronchodilator FEF25-75% % predicted 기간: week 12, 24 and 28	week 12, 24 and 28
Change from baseline in pre-bronchodilator MEF50% % predicted 기간: week 12, 24 and 28	week 12, 24 and 28
Change from baseline in pre-bronchodilator MEF25%% predicted 기간: week 12, 24 and 28	week 12, 24 and 28
Proportion of patients with at least one pulmonary exacerbation during the treatment period as described in Rosenfeld et al. 기간: 28 weeks	28 weeks
Time to first pulmonary exacerbation 기간: 28 weeks	28 weeks
Number of pulmonary exacerbations during the treatment period 기간: 28 weeks	28 weeks
Proportion of patients with at least 1 hospitalisation for a pulmonary exacerbation during the treatment period 기간: 28 weeks	28 weeks
Time to first hospitalisation for a pulmonary exacerbation 기간: 28 weeks	28 weeks
Number of hospitalisations for a pulmonary exacerbation 기간: 28 weeks	28 weeks
Number of days in hospital for a pulmonary exacerbation 기간: 28 weeks	28 weeks
Proportion of patients with at least one pulmonary exacerbation requiring i.v. antibiotics during the treatment period 기간: 28 weeks	28 weeks
Time to first course of i.v. antibiotics for a pulmonary exacerbation 기간: 28 weeks	28 weeks
Number of pulmonary exacerbations requiring i.v. antibiotics during the treatment period 기간: 28 weeks	28 weeks
Number of days of i.v. antibiotic use for pulmonary exacerbations during the treatment period 기간: 28 weeks	28 weeks
Change from baseline in weight 기간: 28 weeks	28 weeks
Change from baseline in height (in pediatrics) 기간: 28 weeks	28 weeks
Change from baseline in weight for age percentiles 기간: 28 weeks	28 weeks
Change from baseline in weight for age percentiles (in pediatrics) 기간: 28 weeks	28 weeks
Change from baseline in weight expressed as % ideal body weight (IBW) 기간: 28 weeks	28 weeks
Change from baseline in body mass index 기간: 28 weeks	28 weeks
Change from baseline in BMI for age percentiles 기간: 28 weeks	28 weeks
Change from baseline in blood levels of cytokines, chemokines and other inflammatory mediators 기간: 28 weeks	28 weeks
Change in patient's health status as reported by patient 기간: 28 weeks	28 weeks
Change in patient's health status as reported by physician 기간: 28 weeks	28 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Boehringer Ingelheim

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

2003년 5월 1일

기본 완료 (실제)

2004년 7월 1일

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2003년 5월 13일

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