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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* 27 12 11 1 51 
  Normal/Hyperplasia 106 18 12 1 137 
  Metaplasia 35 21 12 68 
  Mild dysplasia 62 32 40 134 
  Moderate dysplasia 7 11 
  Severe dysplasia 1 
  Total 238 84 79 403 
 Pulmicort Turbuhaler group       
  Not sampled 49 13 15 3 80 
  Normal/Hyperplasia 124 16 7 147 
  Metaplasia 34 15 56 
  Mild dysplasia 47 21 37 1§ 108 
  Moderate dysplasia 4 
  Severe dysplasia 2 
  Total 260 60 75 399 
Pathologic grades of bronchial biopsies at 6-month follow-up
Normal/HyperplasiaMetaplasiaDysplasiaTotal
MildModerateSevere
Pathologic grades of bronchial biopsies at baseline       
 Placebo group       
  Not sampled* 27 12 11 1 51 
  Normal/Hyperplasia 106 18 12 1 137 
  Metaplasia 35 21 12 68 
  Mild dysplasia 62 32 40 134 
  Moderate dysplasia 7 11 
  Severe dysplasia 1 
  Total 238 84 79 403 
 Pulmicort Turbuhaler group       
  Not sampled 49 13 15 3 80 
  Normal/Hyperplasia 124 16 7 147 
  Metaplasia 34 15 56 
  Mild dysplasia 47 21 37 1§ 108 
  Moderate dysplasia 4 
  Severe dysplasia 2 
  Total 260 60 75 399 
*

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).

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