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).

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.

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

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).

Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.

Oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.

Total of all reporting groups

All patients on BIBW2948 treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks. And oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.

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).

The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.

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).

The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.

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.

The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.

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).

The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.

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).

The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.

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).

The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.

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).

The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.

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).

The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.

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).

The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.

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).

The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.

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).

The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.

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).

The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.

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).

The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.

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).

The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.

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).

The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.

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).

The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.

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).

The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.

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).

The treated set (TS), included all treated patients. Only patients with non-missing outcome measures were included. Results are reported by pooled treatment groups (i.e. pooled group of placebo vs. pooled group of BIBW-treated patients), as defined in the statistical analysis plan.

Oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.

All patients on Placebo Treatment. Oral inhalation of two 7.5 milligram (mg) capsules of placebo for HandiHaler® (15 mg in total) twice daily (b.i.d). And Oral inhalation of four 7.5 milligram (mg) capsules of placebo for HandiHaler® (30 mg in total) twice daily (b.i.d).

Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.

Oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d) over a treatment period of 4 weeks.

All patients on BIBW2948 Treatment. Oral inhalation of two 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (15 mg in total) twice daily (b.i.d). And Oral inhalation of four 7.5 milligram (mg) capsules of BIBW2948 for HandiHaler® (30 mg in total) twice daily (b.i.d).

All patients in the study combined. (Placebo + BIBW2948)