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

This study has been terminated.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00060801
First received: May 13, 2003
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Drug: BIIL 283 BS (Amelubent)
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) (percent predicted) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with at least one pulmonary exacerbation during the treatment period as per definition of Fuchs et al [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in post-bronchodilator forced vital capacity (FVC) percent predicted [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in post-bronchodilator maximal expiratory flow when 50% of FVC remains in lung (MEF50% )percent predicted [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in post-bronchodilator maximal expiratory flow when 25% of FVC remains in lung (MEF25%) percent predicted [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in post-bronchodilator inspiratory capacity (IC) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in post-bronchodilator slow vital capacity (SVC) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in pre-bronchodilator FEV1% predicted [ Time Frame: week 12, 24 and 28 ] [ Designated as safety issue: No ]
  • Change from baseline in pre-bronchodilator FVC % predicted [ Time Frame: week 12, 24 and 28 ] [ Designated as safety issue: No ]
  • Change from baseline in pre-bronchodilator FEF25-75% % predicted [ Time Frame: week 12, 24 and 28 ] [ Designated as safety issue: No ]
  • Change from baseline in pre-bronchodilator MEF50% % predicted [ Time Frame: week 12, 24 and 28 ] [ Designated as safety issue: No ]
  • Change from baseline in pre-bronchodilator MEF25%% predicted [ Time Frame: week 12, 24 and 28 ] [ Designated as safety issue: No ]
  • Proportion of patients with at least one pulmonary exacerbation during the treatment period as described in Rosenfeld et al. [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Time to first pulmonary exacerbation [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Number of pulmonary exacerbations during the treatment period [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with at least 1 hospitalisation for a pulmonary exacerbation during the treatment period [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Time to first hospitalisation for a pulmonary exacerbation [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Number of hospitalisations for a pulmonary exacerbation [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Number of days in hospital for a pulmonary exacerbation [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with at least one pulmonary exacerbation requiring i.v. antibiotics during the treatment period [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Time to first course of i.v. antibiotics for a pulmonary exacerbation [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Number of pulmonary exacerbations requiring i.v. antibiotics during the treatment period [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Number of days of i.v. antibiotic use for pulmonary exacerbations during the treatment period [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in weight [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in height (in pediatrics) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in weight for age percentiles [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in weight for age percentiles (in pediatrics) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in weight expressed as % ideal body weight (IBW) [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in body mass index [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in BMI for age percentiles [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in blood levels of cytokines, chemokines and other inflammatory mediators [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Change in patient's health status as reported by patient [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
  • Change in patient's health status as reported by physician [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 420
Study Start Date: May 2003
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060801

  Show 35 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00060801     History of Changes
Other Study ID Numbers: BI 543.45
Study First Received: May 13, 2003
Last Updated: October 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Boehringer Ingelheim:
Cystic Fibrosis
BIIL 284
Boehringer Ingelheim

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014