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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00060801
• Other study ID #: BI 543.45
• Status: Terminated
• Phase: Phase 2
• First received: May 13, 2003
• Last updated: October 30, 2013
• Start date: May 2003

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 420
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• BIIL 283 BS (Amelubent)

Locations

Country	Name	City	State
United States	Children's Hospital Medical Center of Akron	Akron	Ohio
United States	Albany Medical College	Albany	New York
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Children's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Children's Memorial Hospital	Chicago	Illinois
United States	Children's Hospital Medical Center	Cincinnati	Ohio
United States	Rainbow Babies & Children's Hospital	Cleveland	Ohio
United States	Columbus Children's Hospital	Columbus	Ohio
United States	Children's Memorial Center of Dallas	Dallas	Texas
United States	University of Colorado	Denver	Colorado
United States	Texas Children's Hospital	Houston	Texas
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	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	University of Wisconsin Hospitals & Clinics	Madison	Wisconsin
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt Children's Hospital	Nashville	Tennessee
United States	Tulane University	New Orleans	Louisiana
United States	University of Nebraska	Omaha	Nebraska
United States	The Nemours Children's Clinic	Orlando	Florida
United States	Stanford University Medical Center	Palo Alto	California
United States	MCP Hospital	Philadelphia	Pennsylvania
United States	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Rochester	Rochester	New York
United States	Children's Hospital & Health Center	San Diego	California
United States	University of California at San Francisco	San Francisco	California
United States	Washington University-St. Louis Children's Hospital	St. Louis	Missouri
United States	Pediatric Pulmonary Associates, PA	St. Petersburg	Florida
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

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