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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 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering

420

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

6 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling

Hva måler studien?

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. mai 2003

Primær fullføring (Faktiske)

1. juli 2004

Datoer for studieregistrering

Først innsendt

13. mai 2003

Først innsendt som oppfylte QC-kriteriene

13. mai 2003

Først lagt ut (Anslag)

14. mai 2003

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

31. oktober 2013

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. oktober 2013

Sist bekreftet

1. oktober 2013

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • BI 543.45

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Abonnere