Effect of BIBW 2948 BS in COPD

Phase 2CompletedNCT00423137

Boehringer Ingelheim48 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pulmonary Disease, Chronic Obstructive Bronchitis, Chronic

Interventions

BIBW 2948 BSDRUG

Capsule

PlaceboDRUG

Capsule

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (6)

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

Outcomes

Primary Outcomes

Change From Baseline in Volume of Mucin Per Surface Area of Basal Lamina

Change from baseline in volume of mucin per surface area of basal lamina. Volume of mucin per surface area of basal lamina (vs mu,bala) was determined by stereologic quantification of Periodic Acid Schiff's (AB/PAS) reagent staining in endobronchial biopsies at visit 2 (baseline) and at the end of the 4-week period of randomized treatment (visit 5).

Time frame: At baseline (visit 2) and at visit 5.

Secondary Outcomes

Change From Baseline of Volume of Mucin Per Volume of Epithelium (Vv mu, ep) in Endobronchial Biopsies

Change from baseline of volume of mucin per volume of epithelium (Vv mu, ep) in endobronchial biopsies. The volume of mucin per volume of epithelium (Vv mu, ep), as measured by stereological quantification of AB/PAS staining in endobronchial biopsies was performed at baseline (visit 2) and at the end of the 4-week period of randomised treatment (visit 5).

Time frame: At baseline (visit 2) and at visit 5.

Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Differential (in %)

Change from baseline in bronchoalveolar lavage (BAL) cell differential (in %). Differential cell counts were performed on bronchoalveolar lavage samples obtained during visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).

Time frame: At baseline (visit 2) and at visit 5.

Change From Baseline in Bronchoalveolar Lavage (BAL) Cell Count

Change from baseline in bronchoalveolar lavage (BAL) cell count. Total cell counts were performed on bronchoalveolar lavage (BAL) samples obtained during visit 2 (baseline) and at the end of the 4-week period of randomised treatment.

Time frame: At baseline (visit 2) and at visit 5.

Change From Baseline in Log MUC2 Mucin Gene Expression (RNA) Obtained in Epithelial Brushings

Data from ClinicalTrials.gov

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1219.5.06 Boehringer Ingelheim Investigational Site

Freiburg/Breisgau, Germany

1219.5.05 Boehringer Ingelheim Investigational Site

Hanover, Germany

Change from baseline in log MUC2 Mucin gene expression (RNA) obtained in epithelial brushings. Gene expression levels of the gel-forming mucins (MUC2) were quantified using two-step real time polymerase chain reaction (PCR) from RNA extracted from the cells obtained from the epithelial brushings during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).

Time frame: At baseline (visit 2) and at visit 5.

Change From Baseline in Log Mucin Gene (MUC5AC) Expression Level Obtained in Epithelial Brushings

Change from baseline in log mucin gene (MUC5AC) expression level obtained in epithelial brushings. Gene expression levels of the gel-forming mucins (MUC5AC) were quantified using two-step real time polymerase chain reaction (PCR) from RNA extracted from the cells obtained from the epithelial brushings during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).

Time frame: At baseline (visit 2) and at visit 5.

Change From Baseline in Log Mucin Gene (MUC5B) Expression Level Obtained in Epithelial Brushings

Change from baseline in log mucin gene (MUC5B) expression level obtained in epithelial brushings. Gene expression levels of the gel-forming mucins (MUC5B) were quantified using two-step real time polymerase chain reaction (PCR) from RNA extracted from the cells obtained from the epithelial brushings during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).

Time frame: At baseline (visit 2) and at visit 5.

Change From Baseline in Log Mucin Gene (MUC8) Expression Level Obtained in Epithelial Brushings

Change from baseline in log mucin gene (MUC8) expression level obtained in epithelial brushings. Gene expression levels of the gel-forming mucins (MUC8) were quantified using two-step real time polymerase chain reaction (PCR) from RNA extracted from the cells obtained from the epithelial brushings during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).

Time frame: At baseline (visit 2) and at visit 5.

Change From Baseline in Epidermal Growth Factor Receptor (EGRF) Internalization Assay in Epithelial Brushings - Cells With Bright Spots With Marker

Change in percentage of cells with bright spots with marker. The degree of EGFR internalization (and hence activation) was measured using antibody or ligand labeling techniques in epithelial brushing samples obtained during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5). Measurements visit 2 are used to standardize measurements at visit 5, and the standardized visit 5 value is calculated in percent (%) control as (visit5/visit2\*100).

Time frame: At baseline (visit 2) and at visit 5.

Change From Baseline in Epidermal Growth Factor Receptor (EGRF) Internalization Assay in Epithelial Brushings - EGRF Spots at Nucleus

Change in number of EGRF spots at nucleus. The degree of EGFR internalization (and hence activation) was measured using antibody or ligand labeling techniques in epithelial brushing samples obtained during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5). Measurements visit 2 are used to standardize measurements at visit 5, and the standardized visit 5 value is calculated in percent (%) control as (visit5/visit2\*100).

Time frame: At baseline (visit 2) and at visit 5.

Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - EGRF Spots With Marker

Change in number of EGRF spots with marker per cell. The degree of EGFR internalization (and hence activation) was measured using antibody or ligand labeling techniques in epithelial brushing samples obtained during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5). Measurements visit 2 are used to standardize measurements at visit 5, and the standardized visit 5 value is calculated in percent (%) control as (visit5/visit2\*100).

Time frame: At baseline (visit 2) and at visit 5.

Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - Total Area Bright Spots With Marker

Change in total area bright spots with marker. The degree of EGFR internalization (and hence activation) was measured using antibody or ligand labeling techniques in epithelial brushing samples obtained during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5). Measurements visit 2 are used to standardize measurements at visit 5, and the standardized visit 5 value is calculated in percent (%) control as (visit5/visit2\*100).

Time frame: At baseline (visit 2) and at visit 5.

Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - EGFR Spots

Change in number of EGFR spots per cell. The degree of EGFR internalization (and hence activation) was measured using antibody or ligand labeling techniques in epithelial brushing samples obtained during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5). Measurements visit 2 are used to standardize measurements at visit 5, and the standardized visit 5 value is calculated in % control as (visit5/visit2\*100).

Time frame: At baseline (visit 2) and at visit 5.

Change From Baseline in Epidermal Growth Factor Receptor (EGFR) Internalization Assay in Epithelial Brushings - EGFR Spots at Nucleus With Marker

Change in number of EGFR spots at nucleus per cell with marker. The degree of EGFR internalization (and hence activation) was measured using antibody or ligand labeling techniques in epithelial brushing samples obtained during the endobronchial biopsy at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5). Measurements visit 2 are used to standardize measurements at visit 5, and the standardized visit 5 value is calculated in % control as (visit5/visit2\*100).

Time frame: At baseline (visit 2) and at visit 5.

Change From Baseline in Number of Goblet Cells Per Surface Area of Basel Lamina

Change from baseline in number of goblet cells per surface area of basel lamina, using endobronchial biopsies, taken at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).

Time frame: At baseline (visit 2) and at visit 5.

Change From Baseline in Number of Goblet Cells Per Volume of Epithelium

Change from baseline in number of goblet cells per volume of epithelium, using endobronchial biopsies, taken at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).

Time frame: At baseline (visit 2) and visit 5.

Change From Baseline in Goblet Cell Volume

Change from baseline in goblet cell volume, using endobronchial biopsies, taken at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).

Time frame: At baseline (visit 2) and visit 5.

Change From Baseline of Interleukin-8 (IL-8) Levels in Bronchoalveolar Lavage

Change from baseline of Interleukin-8 (IL-8) levels in bronchoalveolar lavage. IL-8 levels, were measured by enzyme linked immunosorbent assay in bronchoalveolar lavage samples at visit 2 (baseline) and at the end of the 4-week period of treatment (visit 5).

Time frame: At baseline (visit 2) and at visit 5.

Change From Baseline in Myeloperoxidase (MPO) Levels in Bronchoalveolar Lavage

Change from baseline in Myeloperoxidase (MPO) levels in bronchoalveolar lavage. Myeloperoxidase (MPO) activity levels were measured by enzyme linked immunosorbent or radioimmunoassay assay in bronchoalveolar lavage samples at visit 2 (baseline) and at the end of the 4-week period of randomised treatment (visit 5).

Time frame: At baseline (visit 2) and at visit 5.