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Effect of BIBW 2948 BS in COPD

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00423137
First received: January 17, 2007
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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


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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Volume of Mucin per surface area basal lamina [ Time Frame: 28 Day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Volume of mucin per volume of epithelium (Vv mu, ep) in endobronchial biopsies [ Time Frame: 28 Day ] [ Designated as safety issue: No ]
  • Total and Differential Cell Counts in bronchoalveolar lavage [ Time Frame: 28 day ] [ Designated as safety issue: No ]
  • Mucin gene, and Epidermal Growth Factor Receptor (EGFR) gene expression (RNA) in epithelial brushings [ Time Frame: 28 day ] [ Designated as safety issue: No ]
  • EGFR internalization assay in epithelial brushings [ Time Frame: 28 day ] [ Designated as safety issue: No ]
  • Goblet cell size and number in endobronchial biopsies [ Time Frame: 28 day ] [ Designated as safety issue: No ]
  • Interleukin-8 (IL-8) levels in bronchoalveolar lavage [ Time Frame: 28 day ] [ Designated as safety issue: No ]
  • Myeloperoxidase (MPO) levels in bronchoalveolar lavage [ Time Frame: 28 day ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: January 2007
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423137

Locations
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
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00423137     History of Changes
Other Study ID Numbers: 1219.5, 2006-001975-40
Study First Received: January 17, 2007
Last Updated: April 30, 2014
Health Authority: Germany: BfArM Bundesinstitut fuer Arzneimittel und Medizinprodukte
United States: Food and Drug Administration

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Disease Attributes
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 20, 2014