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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Taaislijmziekte

Interventie / Behandeling

Geneesmiddel: BIIL 283 BS (Amelubent)

Studietype

Ingrijpend

Inschrijving

420

Fase

Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

6 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Behandeling

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Boehringer Ingelheim

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2003

Primaire voltooiing (Werkelijk)

1 juli 2004

Studieregistratiedata

Eerst ingediend

13 mei 2003

Eerst ingediend dat voldeed aan de QC-criteria