This Phase 3, randomized, open-label, multicenter study conducted at 44 sites in Europe evaluated the safety and efficacy of a continuous, daily regimen of levonorgestrel (LNG) 90 mcg/ethinyl estradiol (EE) 20 mcg compared with a 21-day, cyclic LNG 100 mcg/EE 20 mcg regimen.
These results were also confirmed in a subset of persistent asthmatics, where indacaterol 200 and 400 mcg increased FEV1 by 0.17 L at 5 min (400 mcg) and 0.21 L at 10 min (200 mcg) compared with placebo.
In a 12-week study of once-daily inhaled ciclesonide 80 mcg (n=182) or 320 mcg (n=195) compared with inhaled budesonide 200 mcg (n=177) twice daily, no relevant changes in 24-hour urinary cortisol excretion were observed in patients receiving ciclesonide.
However, an 8-week study reported in abstract form reported a significant difference (P=0.001) in PEF in favour of ciclesonide 320 mcg twice daily compared with budesonide 400 mcg twice daily (Adachi et al. 2006).
In contrast, Adachi et al. (2006) reported significantly lower use of rescue medication (P=0.007) and improved symptom scores (P=0.008) with ciclesonide 320 mcg twice daily compared with budesonide 400 mcg twice daily after 8 weeks' treatment in 319 patients with moderate to severe asthma.
In a 12-week trial of 141 patients with severe, persistent asthma, use of ciclesonide significantly reduced the need for oral corticosteroid at doses of 320 or 640 mcg twice daily compared with placebo.
The standard dose used for the treatment of MS (44 mcg tiw) was compared with two doses lying on either side of the recommended weekly dosage regimen: one the same dose but less frequent (44 mcg twice weekly [biw]), and the other a higher dose with the same frequency (66 mcg tiw).
Compared with raw MCG, the modified MCG shows a large improvement in reversible capacity, though the cycleability is slightly reduced.
Similarly, although overall judged as having comparable efficacy, ciclesonide 320 mcg once daily resulted in significantly more symptom-free days compared with budesonide 320 mcg once daily in 359 patients with persistent asthma (Boulet et al. 2006a).
This study was conducted to compare ovarian activity of an oral contraceptive containing drospirenone (drsp) 3 mg plus ethinylestradiol (EE) 20 mcg administered in 24/4 regimen compared with the conventional 21/7 regimen, during intended use and following predefined dosing errors.
The results showed preferential binding of WT-GFP protein to DNA containing mCA, mCG and, less efficiently, hmCA compared with non-methylated DNA, confirming the specificity of the method (Fig. 5D).
