Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

30. Oktober 2013 aktualisiert von: 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.

Studienübersicht

Status

Beendet

Bedingungen

Mukoviszidose

Intervention / Behandlung

Arzneimittel: BIIL 283 BS (Amelubent)

Studientyp

Interventionell

Einschreibung

420

Phase

Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

6 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Hauptzweck: Behandlung

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Boehringer Ingelheim

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Mai 2003

Primärer Abschluss (Tatsächlich)

1. Juli 2004

Studienanmeldedaten

Zuerst eingereicht

13. Mai 2003

Zuerst eingereicht, das die QC-Kriterien erfüllt hat