Randomization and withdrawals: Fifty patients were randomized to one or other study treatment (Figure 1). Twenty-five patients received budesonide and 25 placebo. Two patients (one placebo, one budesonide) were found ineligible after randomization, one because of an abnormal chest radiograph and the other because of documented gastroesophageal reflux; they were withdrawn from the study before the end of the first week. Four other patients (three on budesonide) were withdrawn before the end of the second week of treatment, three due to an intercurrent viral infection (one placebo, two budesonide) and one who did not return. These six patients were excluded from the analysis.
Characteristics of inflammatory indices in sputum before treatment: Of the 44 patients who completed the study, 39 (89%) produced mucoid sputum after induction on at least one study visit. Thirty-two patients (73%) produced sputum before any inhaled steroid treatment. Twenty-three patients (52%) were able to produce sputum at each visit; their characteristics were the same as the remainder. The procedure of induction was safe as demonstrated by a trivial mean (95% CI) fall in the postbronchodilator FEV1 of 3.4% (2.8 to 4.0).