in studies 039 and 156, even though it was only in clinically significant study 039th Cilomilast erh Ht and reduced survive without exacerbation and relative risk reduction of at least a Level 2 or Level 3 COPD exacerbation, each in only two of the four studies. No other secondary re And tertiary Re end statistical Ma the discrimination Camptothecin between the treatment and placebo groups cilomilast. Overall, data from phase III studies, the effectiveness neutral and disappointed Uschend. The first three tests are developed for better show a difference in FEV1 between cilomilast and placebo groups of 120 ml, this level of improvement in lung function was improved upon the promising efficacy results in the examination of the 032 Phase II dose-finding study cilomilast Trough FEV1 those obtained at week 6 in 130 ml and 160 ml, compared to baseline and placebo.
However, using the results of the study as 39, for example, the difference between the beginning of FEV1 between the placebo and treatment groups was 40 ml cilomilast representing only 3 of the average output value and IC-87114 the bottom 50 of the reversibility t by inhaled salbutamol performed. This level of improvement is not considered clinically important. Moreover, as noted by the director of the FDA’s Division of Pharmaceutical lung and allergy in a note to the members of the Pulmonary and Allergy Drugs Advisory Committee, a meta-analysis of 13 clinical studies with 244 subjects, showed that oral Theophylline improves FEV1 in patients with stable COPD of approximately 100 ml, far superior to that produced by cilomilast.
The results of the SGRQ should be considered also developed as part of the scoring system of Jones and his colleagues. So total scores ?, ? and ? 2 showed that intervention has an effect, marginally effective, m Moderately effective and very efficient, are. In one of the four major efficacy trials, a clinically significant improvement of Lebensqualit t and the total score for this study compared to placebo at the beginning of the study showed that cilomilast was only slightly effective. Break down the score that cilomilast significantly and clinically activity t and symptoms improved My versus placebo, w While the G Residents were statistically but not clinically significant effects. Thus, the superiority of cilomilast is modest compared to placebo in study 039 was more or less divided into three areas of the SGRQ.
The poor performance of cilomilast in these efficacy studies is difficult to justify given the get respectable improvement in FEV1 in the test 032nd However, it is likely that the maximum tolerated dose of cilomilast f at the edge of the dose-response curve to falls and the narrow therapeutic index of this compound prevents efficiency rates. This M Possibility k Nnte An important factor in the lack of Koh Difference be between the Phase II and Phase III efficacy studies and the lack of a dose-response relationship in the test 032, where cilomilast a Comparison Placebo 5 mg, 10 mg and 15 mg. Theoretically, k Nnte this explanation: tion be tested empirically, as if pharmacokinetic