Bronchodilator response to formoterol after regular tiotropium or to tiotropium after regular formoterol in COPD patients

We conducted a randomized, crossover trial with tiotropium 18 jig once daily (group A), and formoterol 12 mu g twice daily (group B) over a 5-day period for each drug, with a 10-day washout, in 20 COPD patients. At the end of each period, patients inhaled both drugs separated by 180 min in alternate sequence (group A: tiotropium 18 mu g+formoterol 12 mu g; group B: formoterol 12 mu g+tiotropium 18 mu g). FEV1 and FVC were measured at baseline and after 30, 60, 120, 180, 210, 240, 300 and 360 min. FEV1 and FVC further improved after crossover with both sequences. The mean maximal change in FEV1 over baseline was 0.226L (0.154-0.298) after tiotropium+formoterol and 0.228L (0.165 0.291) after formoterol+tiotropium; the mean maximal change in FEV1 over pre-inhatation the second drug value was 0.081 L (0.029-0.133) after tiotropium+formoterol and 0.054L (0.016-0.092) after formoterol+tiotropium. The mean maximal change in FVC over baseline was 0.519L (0.361-0.676) after tiotropium+formoterol and 0.495L (0.307-0.683) after formoterol+tiotropium; the mean maximal change in FVC over pre-inhatation of the second drug value was 0.159L (0.048-0.270) after tiotropium+formoterol and 0.175L (0.083-0.266) after formoterol+tiotropium. The FEV1 AUCs(0 360min) were 62.70 (45.67-79.74) after tiotropium+formoterol and 69.20 (50.84-87.57) after formoterol+tiotropium, the FEV1 AUCs(0-180min) were 24.70 (18.19 31.21) after tiotropium+formoterol and 29.74 (21.02-38.46) after formoterol+tiotropium, whereas the FEV1 AUCs(180-360min) were 15.70 (10.88-20.52) after tiotropium+formoterol and 11.71 (7.21-16.21) after formoterol+tiotropium. Differences between the two treatments were not statistically significant (P > 0.05). The addition of second different long-acting bronchodilator to a regularly administered long-acting bronchoditator seems to be to patient's advantage. (c) 2004 Elsevier Ltd. All rights reserved.