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

Primary Purpose

Cystic Fibrosis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BIIL 283 BS (Amelubent)
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, BIIL 284, Boehringer Ingelheim

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Arizona
  • University of Arkansas for Medical Sciences
  • Children's Hospital of Los Angeles
  • Stanford University Medical Center
  • Children's Hospital & Health Center
  • University of California at San Francisco
  • University of Colorado
  • The Nemours Children's Clinic
  • Pediatric Pulmonary Associates, PA
  • Children's Memorial Hospital
  • Loyola University Medical Center
  • Riley Hospital
  • University of Iowa Hospitals and Clinics
  • University of Kentucky
  • Tulane University
  • Massachusetts General Hospital
  • Children's Hospital
  • University of Michigan Health System
  • University of Minnesota
  • Washington University-St. Louis Children's Hospital
  • University of Nebraska
  • Albany Medical College
  • University of Rochester
  • University of North Carolina
  • Children's Hospital Medical Center of Akron
  • Children's Hospital Medical Center
  • Rainbow Babies & Children's Hospital
  • Columbus Children's Hospital
  • MCP Hospital
  • St. Christopher's Hospital for Children
  • Children's Hospital of Pittsburgh
  • Vanderbilt Children's Hospital
  • Children's Memorial Center of Dallas
  • Texas Children's Hospital
  • University of Wisconsin Hospitals & Clinics

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 13, 2003
Last Updated
October 30, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00060801
Brief Title
Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult and Pediatric Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Study Start Date
May 2003 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis, BIIL 284, Boehringer Ingelheim

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
420 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BIIL 283 BS (Amelubent)
Primary Outcome Measure Information:
Title
Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) (percent predicted)
Time Frame
28 weeks
Title
Proportion of patients with at least one pulmonary exacerbation during the treatment period as per definition of Fuchs et al
Time Frame
28 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in post-bronchodilator forced vital capacity (FVC) percent predicted
Time Frame
28 weeks
Title
Change from baseline in post-bronchodilator mean forced expiratory flow during the middle half of the FVC (FEF25-75% ) percent predicted
Time Frame
28 weeks
Title
Change from baseline in post-bronchodilator maximal expiratory flow when 50% of FVC remains in lung (MEF50% )percent predicted
Time Frame
28 weeks
Title
Change from baseline in post-bronchodilator maximal expiratory flow when 25% of FVC remains in lung (MEF25%) percent predicted
Time Frame
28 weeks
Title
Change from baseline in post-bronchodilator inspiratory capacity (IC)
Time Frame
28 weeks
Title
Change from baseline in post-bronchodilator slow vital capacity (SVC)
Time Frame
28 weeks
Title
Change from baseline in pre-bronchodilator FEV1% predicted
Time Frame
week 12, 24 and 28
Title
Change from baseline in pre-bronchodilator FVC % predicted
Time Frame
week 12, 24 and 28
Title
Change from baseline in pre-bronchodilator FEF25-75% % predicted
Time Frame
week 12, 24 and 28
Title
Change from baseline in pre-bronchodilator MEF50% % predicted
Time Frame
week 12, 24 and 28
Title
Change from baseline in pre-bronchodilator MEF25%% predicted
Time Frame
week 12, 24 and 28
Title
Proportion of patients with at least one pulmonary exacerbation during the treatment period as described in Rosenfeld et al.
Time Frame
28 weeks
Title
Time to first pulmonary exacerbation
Time Frame
28 weeks
Title
Number of pulmonary exacerbations during the treatment period
Time Frame
28 weeks
Title
Proportion of patients with at least 1 hospitalisation for a pulmonary exacerbation during the treatment period
Time Frame
28 weeks
Title
Time to first hospitalisation for a pulmonary exacerbation
Time Frame
28 weeks
Title
Number of hospitalisations for a pulmonary exacerbation
Time Frame
28 weeks
Title
Number of days in hospital for a pulmonary exacerbation
Time Frame
28 weeks
Title
Proportion of patients with at least one pulmonary exacerbation requiring i.v. antibiotics during the treatment period
Time Frame
28 weeks
Title
Time to first course of i.v. antibiotics for a pulmonary exacerbation
Time Frame
28 weeks
Title
Number of pulmonary exacerbations requiring i.v. antibiotics during the treatment period
Time Frame
28 weeks
Title
Number of days of i.v. antibiotic use for pulmonary exacerbations during the treatment period
Time Frame
28 weeks
Title
Change from baseline in weight
Time Frame
28 weeks
Title
Change from baseline in height (in pediatrics)
Time Frame
28 weeks
Title
Change from baseline in weight for age percentiles
Time Frame
28 weeks
Title
Change from baseline in weight for age percentiles (in pediatrics)
Time Frame
28 weeks
Title
Change from baseline in weight expressed as % ideal body weight (IBW)
Time Frame
28 weeks
Title
Change from baseline in body mass index
Time Frame
28 weeks
Title
Change from baseline in BMI for age percentiles
Time Frame
28 weeks
Title
Change from baseline in blood levels of cytokines, chemokines and other inflammatory mediators
Time Frame
28 weeks
Title
Change in patient's health status as reported by patient
Time Frame
28 weeks
Title
Change in patient's health status as reported by physician
Time Frame
28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5073
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304-5786
Country
United States
Facility Name
Children's Hospital & Health Center
City
San Diego
State/Province
California
ZIP/Postal Code
92128-4284
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0106
Country
United States
Facility Name
University of Colorado
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
The Nemours Children's Clinic
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Pediatric Pulmonary Associates, PA
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153-3333
Country
United States
Facility Name
Riley Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5225
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0284
Country
United States
Facility Name
Tulane University
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0212
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University-St. Louis Children's Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-5190
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7220
Country
United States
Facility Name
Children's Hospital Medical Center of Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308-1062
Country
United States
Facility Name
Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Rainbow Babies & Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Columbus Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
45205
Country
United States
Facility Name
MCP Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19129
Country
United States
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt Children's Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2586
Country
United States
Facility Name
Children's Memorial Center of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Wisconsin Hospitals & Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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

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