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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.
 
ClinicalTrials.gov Identifier: NCT00423137
Recruitment Status : Completed
First Posted : January 18, 2007
Last Update Posted : May 16, 2014
Sponsor:
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

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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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00423137


Locations
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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
Germany
1219.5.06 Boehringer Ingelheim Investigational Site
Freiburg/Breisgau, Germany
1219.5.05 Boehringer Ingelheim Investigational Site
Hannover, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00423137    
Other Study ID Numbers: 1219.5
2006-001975-40
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: May 16, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Bronchitis
Bronchitis, Chronic
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Infections