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Aim: In this randomized, double-blind, crossover study, we explored the acute effects on respiratory function and safety of an additional dose of indacaterol 150 µg instable COPD patients regularly treated with a conventional dose of indacaterol 150 µg. Methods: On two non-consecutive days, patients inhaled indacaterol 150 µg. After 180 min, they inhaled an additional dose of indacaterol 150 µg or placebo. Lung function, oxygen saturation by pulse oximetry (SpO2) and heart rate were measured before the first drug administration and up to 360 min thereafter. Results: In both treatment groups, indacaterol induced a significant (P < 0.05) bronchodilation during all the study time. The difference between the FEV1 AUCs0-180 min was not statistically significant (P = 0.971). On the contrary, the difference between the FEV1 AUCs180-360 min was significant (P < 0.0001). However, only 8 out of 20 patients showed a further increase of at least 100ml from the peak obtained after the first administration of indacaterol 150 µg with the second dose of 150 µg. Indacaterol 150 µg induced a modest but significant decrease in SpO2 up to 60 min and a second dose of indacaterol 150 µg significantly decreased the SpO2 mean value up to 360min. Conclusion: This study suggests that it is reasonable and safe to increase the dose of indacaterol in those stable COPD patients who are under regular therapy with indacaterol 150 µg from which they do not draw the maximum benefit because they are unable to perceive bronchodilation. However, only a minority of patients seem to benefit from this dose escalation, at least in terms of spirometric improvement. [ABSTRACT FROM AUTHOR]

Summary: We conducted a population-based cross-sectional epidemiologic survey of asthma and COPD in an adult representative national sample using information obtained from the Health Search Database owned by the Italian College of General Practitioners. General Practitioners who had a list of patient population of 909,638 individuals (429,962 men and 479,676 women; man/woman ratio [M/WR]: 0.89) ≥14 years old at the end of December 2009 were selected to be representatives of the whole Italian population. Cases of asthma and COPD were identified on the basis of the ICD-9 codes. The total sample included 55,500 (6.10% of the entire population; 5.49% of men and 6.64% of women; M/WR: 0.74) subjects suffering from asthma and 25,762 (2.83% of the entire population; 3.51% of men and 2.23% of women; M/WR: 1.41) subjects suffering from COPD. The asthma/COPD ratio in general population was 2.16. The odds ratio (OR) was chosen because asthma and COPD had a prevalence less than 10%. The OR of developing asthma decreased with age both in men and women, but in the first group of age (15–34 years) it was higher in men vs. women (1.69 vs. 1.00) although it became lower than 1 from 35 years old and up in men and from 75 years old and up in women. On the contrary, the OR of developing COPD became higher than 1 from 55 years old and up both in men and in women and progressively increased with age (in the group 75–84 years, it was 6.16 in men and 4.07 in women, respectively). [ABSTRACT FROM AUTHOR]