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In addition, the FDA will focus its review on three key secondary endpoints to evaluate improvement in clinical symptoms and function, including the 6MWD, SGRQ, and the time to / requirement for whole lung lavage.
There was a statistically significant decrease in the values obtained for the parameters of symptom, activity, and effect in the SGRQ evaluation criterion (P < 0.05).
The researchers found that there was no significant difference between the nintedanib-plus-sildenafil group and the nintedanib group in terms of the adjusted mean change from baseline in the SGRQ total score at week 12 (−1.28 and −0.77 points, respectively; P = 0.72).
The symptom, activity, impact and total scores of SGRQ, and the dyspnea and fatigue scores of CRQ were worse in severe-to-very severe patients than in mild-to-moderate patients at baseline (p<0.05).
Forward stepwise regression analysis was used to identify the resting lung function parameters (spirometry, body plethysmography and [N.sub.2]SBW test) and possible confounders (demographic and clinical data) that were independently related to performance during the CPET (peak V[O.sub.2] and breathing reserve) and HRQoL (CAT, SF36 PCS, SF 36 MCS, and SGRQ).
The median SGRQ total score at follow-up was 33.4 (interquartile range (IQR) 14.1 - 54.1).
Secondary end points included the changes in dyspnoea score (MMRC grade, [SPO.sub.2] and SGRQ score).
They also used the six-minute walk test and the SGRQ to assess improvements.
Total SGRQ and MRC dyspnoea scores were not significantly different between the groups.
Mean [+ or -] SD Age, years 70 [+ or -] 6 Male, number (%) 11 (52%) Height, m 1.66 [+ or -] 0.08 Weight, kg 71 [+ or -] 20 BMI, kg/[m.sup.2] 25.5 [+ or -] 6.5 Cun, cm 2.1 [+ or -] 0.2 Pack years, years 56 [+ or -] 28 GOLD I/II/III/IV, (%) 10/47/29/14 FE[V.sub.1], % pred 50 [+ or -] 21 FVC, % pred 83 [+ or -] 22 FE[V.sub.1]/FVC ratio 0.48 [+ or -] 0.14 TLC, % pred 118 [+ or -] 20 FRC, % pred 146 [+ or -] 34 RV, % pred 167 [+ or -] 60 SGRQ, symptoms 46 [+ or -] 22 SGRQ, activity 62 [+ or -] 14 SGRQ, impact 29 [+ or -] 15 SGRQ, total 43 [+ or -] 14 Data are presented as mean [+ or -] standard deviation (SD).
George's Respiratory Questionnaire (SGRQ) total scores were observed using SGRQ.
A QV foi avaliada atraves do SGRQ. Para o treinamento com carga, foram feitos testes incrementais para ajustar de acordo com cada paciente, indicando que o peso ideal consistia em 50% da carga maxima obtida neste teste.
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