), smoking history (ex-smokers/current smokers), severity of disease, use of ICS at baseline (yes/no) and body mass index (BMI; .30 kg/m2 or #30 kg/m2) within the FAS. The analysis was performed using the proper interaction term inside the model as well as the extra covariate as a fixed impact, if important. All security end points were summarized for the safety population.sample-size calculationTo detect statistical significance inside the primary end point (at =0.05, with 80 power) to get a therapy differential of 70 mL in trough FEV1 at week 12, and assuming a regular deviation of 250 mL along with a 10 dropout rate, it was calculated that an estimated total sample size of 450 sufferers (225 per group) will be necessary (404 completers).Statistical analysisThree populations had been defined within the GLOW6 study for the goal of analysis. The complete evaluation set (FAS) integrated all randomized sufferers who received at the very least one particular dose in the study drug; sufferers had been analyzed as outlined by the therapy they had been assigned to at randomization. The per-protocol set (PPS) included all sufferers within the FAS who had no significant protocol deviations; individuals were analyzed in line with the treatment to which they were randomized. The security population incorporated all patients who received at the very least one particular dose in the study medication, irrespective of randomization; patients had been analyzed in line with the remedy they received. The primary evaluation for trough FEV1 at week 12 was performed around the FAS working with a mixed model. The mixed model contained treatment as a fixed impact, together with the baselineResults Patient disposition and baseline characteristicsA total of 671 sufferers had been screened, of whom 449 were randomized (IND + GLY, 226; IND + PBO, 223; Figure 2); 94 (422 individuals) completed the study. The percentage of sufferers who discontinued was equivalent in each groups. The two most typical factors for discontinuing remedy had been protocol deviation and AEs. Discontinuations had been extra frequent because of protocol deviation within the IND + GLYsubmit your manuscript | www.dovepressInternational Journal of COPD 2014:DovepressDovepress Screened N=Indacaterol and glycopyrronium coadministration in COPDRandomized N=Indacaterol and glycopyrronium N=226 Discontinued Protocol deviation Adverse events Subject withdrew consent Administrative challenges Lost to follow-up Unsatisfactory therapeutic effect CompletedFigure two Patient disposition, n ( ).WS-12 Indacaterol and placebo N=223 14 (6.Amifampridine 2) five (2.PMID:24633055 two) three (1.three) three (1.3) two (0.9) 1 (0.four) 0 212 (93.8) Discontinued Protocol deviation Adverse events Topic withdrew consent Administrative problems Lost to follow-up Unsatisfactory therapeutic impact Completed 13 (5.eight) three (1.3) 5 (2.two) three (1.3) 1 (0.four) 0 1 (0.4) 210 (94.2)group (5 of 14 patients; 2.two ) than inside the IND + PBO group (three of 13 individuals; 1.3 ); they were a lot more frequent due to AEs within the IND + PBO group (5 of 13 individuals; 2.two ) than within the IND + GLY group (3 of 14 individuals; 1.3 ). All baseline qualities were similar in between the therapy groups (Table 1). The imply age of the individuals was 63.7 years, 82 of your sufferers have been male and the majority (99 ) were Caucasian. All patients had moderate (64 ) or extreme (36 ) airflow limitation.1 All sufferers had been smokers (42 ) or ex-smokers (58 ), and the mean smoking history was 44.5 pack-years. The mean duration of COPD was 7.1 years; 30 on the patients had a documented history of at the least a single exacerbation in the prior year; 63 from the sufferers made use of ICS.