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

Stopped early · Phase 2

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT00060801

Run by

Boehringer Ingelheim

People needed

420

Starts

2003-05-01

Last updated by the study team

2013-10-31

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Arizona — Tucson, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Children's Hospital of Los Angeles — Los Angeles, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Children's Hospital & Health Center — San Diego, California, United States
• University of California at San Francisco — San Francisco, California, United States
• University of Colorado — Denver, Colorado, United States
• The Nemours Children's Clinic — Orlando, Florida, United States
• Pediatric Pulmonary Associates, PA — St. Petersburg, Florida, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Riley Hospital — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kentucky — Lexington, Kentucky, United States
• Tulane University — New Orleans, Louisiana, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Children's Hospital — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University-St. Louis Children's Hospital — St Louis, Missouri, United States
• University of Nebraska — Omaha, Nebraska, United States
• Albany Medical College — Albany, New York, United States
• University of Rochester — Rochester, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Children's Hospital Medical Center of Akron — Akron, Ohio, United States

Full record on ClinicalTrials.gov

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