Clinical trial NCT00423137: Effect of BIBW 2948 BS in COPD
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Bronchitis, Chronic
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2007-01-18
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Volume of Mucin Per Surface Area of Basal Lamina
timeFrame: At baseline (visit 2) and at visit 5.
Secondary outcomes:
measure: Change From Baseline of Volume of Mucin Per Volume of Epithelium (Vv mu, ep) in Endobronchial Biopsies
timeFrame: At baseline (visit 2) and at visit 5.
measure: Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Differential (in %)
timeFrame: At baseline (visit 2) and at visit 5.
measure: Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Count
timeFrame: At baseline (visit 2) and at visit 5.
measure: Change From Baseline in Log MUC2 Mucin Gene Expression (RNA) Obtained in Epithelial Brushings
timeFrame: At baseline (visit 2) and at visit 5.
measure: Change From Baseline in Log Mucin Gene (MUC5AC) Expression Level Obtained in Epithelial Brushings
timeFrame: At baseline (visit 2) and at visit 5.
measure: Change From Baseline in Log Mucin Gene (MUC5B) Expression Level Obtained in Epithelial Brushings
timeFrame: At baseline (visit 2) and at visit 5.
measure: Change From Baseline in Log Mucin Gene (MUC8) Expression Level Obtained in Epithelial Brushings
timeFrame: At baseline (visit 2) and at visit 5.
measure: Change From Baseline in Epidermal Growth Factor Receptor (EGRF) Internalization Assay in Epithelial Brushings - Cells With Bright Spots With Marker
timeFrame: At baseline (visit 2) and at visit 5.
measure: Change From Baseline in Epidermal Growth Factor Receptor (EGRF) Internalization Assay in Epithelial Brushings - EGRF Spots at Nucleus
timeFrame: At baseline (visit 2) and at visit 5.
measure: Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - EGRF Spots With Marker
timeFrame: At baseline (visit 2) and at visit 5.
measure: Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - Total Area Bright Spots With Marker
timeFrame: At baseline (visit 2) and at visit 5.
measure: Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - EGFR Spots
timeFrame: At baseline (visit 2) and at visit 5.
measure: Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - EGFR Spots at Nucleus With Marker
timeFrame: At baseline (visit 2) and at visit 5.
measure: Change From Baseline in Number of Goblet Cells Per Surface Area of Basel Lamina
timeFrame: At baseline (visit 2) and at visit 5.
measure: Change From Baseline in Number of Goblet Cells Per Volume of Epithelium
timeFrame: At baseline (visit 2) and visit 5.
measure: Change From Baseline in Goblet Cell Volume
timeFrame: At baseline (visit 2) and visit 5.
measure: Change From Baseline of Interleukin-8 (IL-8) Levels in Bronchoalveolar Lavage
timeFrame: At baseline (visit 2) and at visit 5.
measure: Change From Baseline in Myeloperoxidase (MPO) Levels in Bronchoalveolar Lavage
timeFrame: At baseline (visit 2) and at visit 5.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 1219.5.03 Boehringer Ingelheim Investigational Site
state: Alabama
city: San Francisco
country: United States
facility: 1219.5.01 Boehringer Ingelheim Investigational Site
state: California
city: Denver
country: United States
facility: 1219.5.02 Boehringer Ingelheim Investigational Site
state: Colorado
city: Philadelphia
country: United States
facility: 1219.5.04 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Freiburg/Breisgau
country: Germany
facility: 1219.5.06 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1219.5.05 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.