A randomized controlled trial on office spirometry in asthma and COPD in standard general practice: data from spirometry in Asthma and COPD: a comparative evaluation Italian study.

STUDY OBJECTIVES: To evaluate whether office spirometry by general practitioners (GPs) is feasible and may improve the diagnosis of asthma and COPD. METHODS: A prospective, randomized, comparative trial was planned involving 57 Italian pulmonology centers and 570 GPs who had to enroll consecutive subjects aged 18 to 65 years with symptoms of asthma or COPD without a previous diagnosis. Patients were randomized 1:1 into two groups with an interactive voice responding system: conventional evaluation alone vs conventional evaluation and spirometry. Office spirometry was performed by GPs who were trained by reference specialists using a portable electronic spirometer (Spirobank Office; MIR; Rome, Italy). Diagnosis was confirmed by the reference specialist center in blind fashion. RESULTS: Seventy-four GPs complied to the trial. Of 333 patients enrolled, 136 nonrandom violators completed the protocol. Per-protocol analysis showed a concordant diagnosis between GPs and specialists in 78.6% of cases in the conventional evaluation-plus-spirometry group vs 69.2% in the conventional evaluation group (p = 0.35). In the intention-to-treat analysis, the respective percentages of concordant diagnosis were 57.9 and 56.7 (p = 0.87). CONCLUSIONS: Office spirometry by GPs is feasible, but frequent protocol violation and inadequate sample size did not allow us to prove a significant advantage of office spirometry in improving the diagnosis of asthma and COPD in standard general practice as organized at present in Italy, thus reinforcing the need for close cooperation between GPs and specialists in respiratory medicine.

The antiinflammatory activity of budesonide on human airway epithelial cells is lasting after removal of the drug from cultures.

Because of its ability to conjugate extensively with fatty acids within lung cells, it has been suggested that budesonide (Bud) may have a prolonged pharmacologic activity, related to retention of the drug in airway tissues. Using human bronchial epithelial cells (HBECs) as target cells, we evaluated whether Bud could have a long-lasting inhibitory effect on ICAM-1 expression and GM-CSF release. HBECs were cultured in Bud (10 microM) or in medium alone (Ctr) for 24 hr, then extensively washed (to remove Bud) and incubated for an additional 6, 12, or 24 hr with IFN-gamma. ICAM-1 expression and GM-CSF release were then measured by flow cytometric analysis. In Ctr HBECs, IFN-gamma induced a time-dependent upregulation of ICAM-1 expression, significant at 6, 12, or 24 hr (p < 0.05, each comparison), and an increase in GM-CSF release, significant at 24 hr (p < 0.05). The inhibitory effects of Bud preexposure on IFN-gamma-induced ICAM-1 expression and GM-CSF release were then compared with those of a continuous exposure to the drug during IFN-gamma stimulation. Preexposure to Bud (1 and 10 microM) induced a significant inhibition of IFN-gamma-induced ICAM-1 expression (p < 0.05, each comparison), but lower than that observed in HBECs continuously exposed at the same Bud concentrations (p < 0.01, each comparison). In contrast, the inhibition of GM-CSF release was similar in preexposed and in exposed HBECs and statistically significant only at the highest Bud concentration tested (p < 0.05, each comparison). Thus, Bud is effective in vitro in inducing a downregulation lasting 24 hr of mechanisms involved in leukocyte recruitment.