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Cystic FibrosisPhase 2NCT00060801

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

A Phase 2 study testing BIIL 283 BS (Amelubent) in people with Cystic Fibrosis, run by Boehringer Ingelheim at 35 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 6 years and older
Conditions the study is for
Cystic Fibrosis
What is being tested?
BIIL 283 BS (Amelubent)
How many people
420 participants
Where
35 sitesUnited States
Study dates
May 2003to Jul 2004
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308-1062

  • Albany Medical College

    Albany, New York, 12208

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109-0212

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Children's Hospital

    Boston, Massachusetts, 02115

  • University of North Carolina

    Chapel Hill, North Carolina, 27599-7220

  • Children's Memorial Hospital

    Chicago, Illinois, 60614

  • Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3039

  • Rainbow Babies & Children's Hospital

    Cleveland, Ohio, 44106

  • Columbus Children's Hospital

    Columbus, Ohio, 45205

  • Children's Memorial Center of Dallas

    Dallas, Texas, 75235

  • University of Colorado

    Denver, Colorado, 80262

  • Texas Children's Hospital

    Houston, Texas, 77030

  • Riley Hospital

    Indianapolis, Indiana, 46202-5225

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Kentucky

    Lexington, Kentucky, 40536-0284

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Children's Hospital of Los Angeles

    Los Angeles, California, 90027

  • University of Wisconsin Hospitals & Clinics

    Madison, Wisconsin, 53792

  • Loyola University Medical Center

    Maywood, Illinois, 60153-3333

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt Children's Hospital

    Nashville, Tennessee, 37232-2586

  • Tulane University

    New Orleans, Louisiana, 70112

  • University of Nebraska

    Omaha, Nebraska, 68198-5190

  • The Nemours Children's Clinic

    Orlando, Florida, 32801

  • Stanford University Medical Center

    Palo Alto, California, 94304-5786

  • MCP Hospital

    Philadelphia, Pennsylvania, 19129

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • University of Rochester

    Rochester, New York, 14642

  • Children's Hospital & Health Center

    San Diego, California, 92128-4284

  • University of California at San Francisco

    San Francisco, California, 94143-0106

  • Washington University-St. Louis Children's Hospital

    St Louis, Missouri, 63110

  • Pediatric Pulmonary Associates, PA

    St. Petersburg, Florida, 33701

  • University of Arizona

    Tucson, Arizona, 85724-5073

Other trials in United States

About this study

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

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.

Conditions
Cystic Fibrosis
Being tested
BIIL 283 BS (Amelubent)
Keywords
Cystic Fibrosis, BIIL 284, Boehringer Ingelheim
Medical subject headings
Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BIIL 283 BS (Amelubent)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) (percent predicted)

    Measured: 28 weeks

  2. Proportion of patients with at least one pulmonary exacerbation during the treatment period as per definition of Fuchs et al

    Measured: 28 weeks

Secondary outcomes (32)

  1. Change from baseline in post-bronchodilator forced vital capacity (FVC) percent predicted

    Measured: 28 weeks

  2. Change from baseline in post-bronchodilator mean forced expiratory flow during the middle half of the FVC (FEF25-75% ) percent predicted

    Measured: 28 weeks

  3. Change from baseline in post-bronchodilator maximal expiratory flow when 50% of FVC remains in lung (MEF50% )percent predicted

    Measured: 28 weeks

  4. Change from baseline in post-bronchodilator maximal expiratory flow when 25% of FVC remains in lung (MEF25%) percent predicted

    Measured: 28 weeks

  5. Change from baseline in post-bronchodilator inspiratory capacity (IC)

    Measured: 28 weeks

  6. Change from baseline in post-bronchodilator slow vital capacity (SVC)

    Measured: 28 weeks

  7. Change from baseline in pre-bronchodilator FEV1% predicted

    Measured: week 12, 24 and 28

  8. Change from baseline in pre-bronchodilator FVC % predicted

    Measured: week 12, 24 and 28

  9. Change from baseline in pre-bronchodilator FEF25-75% % predicted

    Measured: week 12, 24 and 28

  10. Change from baseline in pre-bronchodilator MEF50% % predicted

    Measured: week 12, 24 and 28

  11. Change from baseline in pre-bronchodilator MEF25%% predicted

    Measured: week 12, 24 and 28

  12. Proportion of patients with at least one pulmonary exacerbation during the treatment period as described in Rosenfeld et al.

    Measured: 28 weeks

  13. Time to first pulmonary exacerbation

    Measured: 28 weeks

  14. Number of pulmonary exacerbations during the treatment period

    Measured: 28 weeks

  15. Proportion of patients with at least 1 hospitalisation for a pulmonary exacerbation during the treatment period

    Measured: 28 weeks

  16. Time to first hospitalisation for a pulmonary exacerbation

    Measured: 28 weeks

  17. Number of hospitalisations for a pulmonary exacerbation

    Measured: 28 weeks

  18. Number of days in hospital for a pulmonary exacerbation

    Measured: 28 weeks

  19. Proportion of patients with at least one pulmonary exacerbation requiring i.v. antibiotics during the treatment period

    Measured: 28 weeks

  20. Time to first course of i.v. antibiotics for a pulmonary exacerbation

    Measured: 28 weeks

  21. Number of pulmonary exacerbations requiring i.v. antibiotics during the treatment period

    Measured: 28 weeks

  22. Number of days of i.v. antibiotic use for pulmonary exacerbations during the treatment period

    Measured: 28 weeks

  23. Change from baseline in weight

    Measured: 28 weeks

  24. Change from baseline in height (in pediatrics)

    Measured: 28 weeks

  25. Change from baseline in weight for age percentiles

    Measured: 28 weeks

  26. Change from baseline in weight for age percentiles (in pediatrics)

    Measured: 28 weeks

  27. Change from baseline in weight expressed as % ideal body weight (IBW)

    Measured: 28 weeks

  28. Change from baseline in body mass index

    Measured: 28 weeks

  29. Change from baseline in BMI for age percentiles

    Measured: 28 weeks

  30. Change from baseline in blood levels of cytokines, chemokines and other inflammatory mediators

    Measured: 28 weeks

  31. Change in patient's health status as reported by patient

    Measured: 28 weeks

  32. Change in patient's health status as reported by physician

    Measured: 28 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2003 (estimated)
  2. Study startMay 2003
  3. Primary completionJul 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Enrolment
420 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00060801
Sponsor's protocol ID
BI 543.45
Status last verified
Oct 2013
First submitted
13 May 2003
Last updated
31 Oct 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BIIL 283 BS (Amelubent) in people with Cystic Fibrosis, run by Boehringer Ingelheim at 35 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in post-bronchodilator forced expiratory volume in one second (FEV1) (percent predicted) (time frame: 28 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00060801.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2013.

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