Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2007-01-17
2008-07-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo - low dose
Twice daily (b.i.d.)
Placebo
Capsule
Placebo - high dose
Twice daily (b.i.d.)
Placebo
Capsule
BIBW2948 - low dose
Twice daily (b.i.d.)
BIBW 2948 BS
Capsule
BIBW2948 - high dose
Twice daily (b.i.d.)
BIBW 2948 BS
Capsule
Interventions
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BIBW 2948 BS
Capsule
Placebo
Capsule
Eligibility Criteria
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Inclusion Criteria
* ages between 40 and 70
Exclusion Criteria
* 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
40 Years
70 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1219.5.03 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1219.5.01 Boehringer Ingelheim Investigational Site
San Francisco, California, United States
1219.5.02 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
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
Hanover, , Germany
Countries
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References
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Woodruff PG, Wolff M, Hohlfeld JM, Krug N, Dransfield MT, Sutherland ER, Criner GJ, Kim V, Prasse A, Nivens MC, Tetzlaff K, Heilker R, Fahy JV. Safety and efficacy of an inhaled epidermal growth factor receptor inhibitor (BIBW 2948 BS) in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2010 Mar 1;181(5):438-45. doi: 10.1164/rccm.200909-1415OC. Epub 2009 Dec 10.
Related Links
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Related Info
Other Identifiers
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2006-001975-40
Identifier Type: -
Identifier Source: secondary_id
1219.5
Identifier Type: -
Identifier Source: org_study_id