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

30. oktober 2013 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding

420

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Boehringer Ingelheim

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2003

Primær færdiggørelse (Faktiske)

1. juli 2004

Datoer for studieregistrering

Først indsendt

13. maj 2003

Først indsendt, der opfyldte QC-kriterier

13. maj 2003

Først opslået (Skøn)

14. maj 2003

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

31. oktober 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2013

Sidst verificeret

1. oktober 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BI 543.45

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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