Table 2

Pathologic grades of bronchial biopsy samples at baseline and after 6 months of intervention: lesion-specific analysis

Pathologic grades of bronchial biopsies at 6-month follow-up
Normal/HyperplasiaMetaplasiaDysplasiaTotal
MildModerateSevere
Pathologic grades of bronchial biopsies at baseline
 Placebo group
  Not sampled*2712111051
  Normal/Hyperplasia106181210137
  Metaplasia3521120068
  Mild dysplasia62324000134
  Moderate dysplasia7130011
  Severe dysplasia101002
  Total238847920403
 Pulmicort Turbuhaler group
  Not sampled4913153080
  Normal/Hyperplasia12416700147
  Metaplasia347150056
  Mild dysplasia4721372108
  Moderate dysplasia410106
  Severe dysplasia200002
  Total260607561399
  • * Not sampled refers to additional biopsies taken at the 6-month follow-up bronchoscopy.

  • Biopsy samples that represent progressive disease. Sites of any grade at baseline could progress. New dysplastic lesions not sampled at baseline were considered as progressive disease because the enrollment criterion was the presence of bronchial dysplasia. Pulmicort Turbuhaler was 10% (40 of 399) and 9.2% (37 of 403) in the Pulmicort Turbuhaler and placebo groups, respectively (P = 0.76, two-sample test for equality of proportions with continuity correction).

  • Biopsy samples that represent a complete response during the intervention period. Only sites of dysplasia could regress to normal/hyperplasia. Complete response was 45.7% (53 of 116) and 47.6% (70 of 147) in the Pulmicort Turbuhaler and placebo groups, respectively (P = 0.85, two sample test for equality of proportions with continuity correction).