At visits 1 and 2, lung function tests were performed (FEV1, FVC and PEF) with standard equipment available at the clinics. At visit 1, the investigators filled in a questionnaire learn more about teaching of Easyhaler® and how easy it was for patients to learn the correct use. 4 Statistical Analyses Changes in lung function variables were analysed using a mixed model for repeated measures (MMRM) and SAS software (SAS Institute Inc., Cary, NC, USA) [28]. Each lung function variable (FEV1,
FVC and PEF) was modelled separately using MMRM, including age group, visit and age group by visit interaction, as independent variables. Repeated statement was used to specify click here the repeated measures factor (visit) and the subject variable (subject) identifying observations that are correlated. Differences between visits in lung functions were obtained using the estimate statement in SAS Proc Mixed.
Estimates of means of each lung function are least square means from the statistical models. 5 Results There was a total of 797 patients included in study A and 219 in study B. Demographic data of the study patients is shown in Table 1 divided by age (children, adolescents, adults, elderly) and diagnosis (asthma, COPD). Gender, age, lung function values as predicted normal values and smoking habits are also reported. Table 1 Demographic data of the patients Children Demeclocycline Adolescents Adults Elderly Total No. of pts 139 80 582 215 1016 Gender Male, n (%) 80 (58) 55 (69) 240 (42) 102 (47) 478 (47) Female, n (%) 59 (42) 25 (31) 338 (58) 111 (53) 532 (53) Not reported 0 0 4 (0) 2 (0) 6 (0) Mean age, years (SD) 7.6 (2.2) 14.5 (1.6) 51.2 (11.1) 72.9 (5.4) NC Age range, years 3–11 12–17 18–65 66–88 3–88 Diagnosis Asthma 139 80 200 51 470 COPD 0 0 344 153 497 Not recorded 0 0 38 11 49 Lung function (mean, SD) FEV1, % pred 100.1 (18.9) 95.8 (14.2) 65.3 (12.3) 61.9
(12.9) NC FVC, % pred 97.3 (19.1) 96.9 (16.0) 80.0 (15.2) 76.9 (17.5) NC PEF, % pred 91.9 (19.7) 98.7 (20.0) 59.6 (17.7) 55.0 (16.3) NC Smokers (%) NR NR NC Never smoker 30.7 32.2 Ex-smoker 22.3 42.4 Smoker 47.0 25.4 COPD chronic obstructive pulmonary disease, FEV 1 forced expiratory volume in 1 s, FVC forced vital capacity, NC not calculated, NR not registered, PEF peak expiratory flow, pred predicted The patients’ previous inhaler use is presented in Table 2. Table 2 Inhaler device used by the patients before the study Children Adolescents Adults Elderly Total pMDI ± RGFP966 order spacer 115 75 159 64 413 Diskus 0 1 22 13 36 Easyhaler® 2 0 12 1 15 Handihaler 0 0 33 17 50 Turbuhaler 0 0 23 5 28 Other 0 0 52 13 65 Not reported 22 4 138 48 212 More than one device 0 0 143 54 197 Total 139 80 582 215 1016 pMDI pressurized metered dose inhaler 5.