COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Effect of BIBW 2948 BS in COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00423137
Recruitment Status : Completed
First Posted : January 18, 2007
Last Update Posted : May 16, 2014
Information provided by:
Boehringer Ingelheim

Brief Summary:
Study of BIBW 2948 BS in Patients with COPD and Chronic Bronchitis

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Bronchitis, Chronic Drug: BIBW 2948 BS Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Effects of a 4-week Treatment of 15 and 30 mg b.i.d BIBW2948 BS (Inhalation Powder, Hard Capsule for HandiHaler®) on Epithelial Mucin Stores and the Safety and Efficacy in COPD Patients With Symptoms Associated With Chronic Bronchitis
Study Start Date : January 2007
Actual Primary Completion Date : July 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Volume of Mucin per surface area basal lamina [ Time Frame: 28 Day ]

Secondary Outcome Measures :
  1. Volume of mucin per volume of epithelium (Vv mu, ep) in endobronchial biopsies [ Time Frame: 28 Day ]
  2. Total and Differential Cell Counts in bronchoalveolar lavage [ Time Frame: 28 day ]
  3. Mucin gene, and Epidermal Growth Factor Receptor (EGFR) gene expression (RNA) in epithelial brushings [ Time Frame: 28 day ]
  4. EGFR internalization assay in epithelial brushings [ Time Frame: 28 day ]
  5. Goblet cell size and number in endobronchial biopsies [ Time Frame: 28 day ]
  6. Interleukin-8 (IL-8) levels in bronchoalveolar lavage [ Time Frame: 28 day ]
  7. Myeloperoxidase (MPO) levels in bronchoalveolar lavage [ Time Frame: 28 day ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • COPD smokers
  • ages between 40 and 70

Exclusion Criteria:

  • Significant other diseases
  • abnormal hematology
  • abnormal liver function
  • psychiatric disorders
  • pulmonary obstruction
  • asthma, allergic rhinitis
  • dependance on oxygen
  • patients with history of myocardial infarction
  • patients with history of cancer
  • women of child bearing potential
  • antiplatelet or anticoagulation therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00423137

Layout table for location information
United States, Alabama
1219.5.03 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
United States, California
1219.5.01 Boehringer Ingelheim Investigational Site
San Francisco, California, United States
United States, Colorado
1219.5.02 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
United States, Pennsylvania
1219.5.04 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1219.5.06 Boehringer Ingelheim Investigational Site
Freiburg/Breisgau, Germany
1219.5.05 Boehringer Ingelheim Investigational Site
Hannover, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim Identifier: NCT00423137    
Other Study ID Numbers: 1219.5
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Disease, Chronic Obstructive
Bronchitis, Chronic
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Infections