Results Although highlighting a general lack of high- quality real-life effectiveness observational research on these clinical ly important topics , the analysis provided insights into how identified observational studies might inform asthma guidelines developers and clinicians .
Overall , RELEVANT appeared reliable and easy to use by expert review ers .
Conclusions Using such quality appraisal tools is m and atory to assess whether specific observational real-life effectiveness studies can be used to inform guideline development and /or decision-making in clinical practice
Abstract Introduction A Task Force was commissioned jointly by the European Academy of Allergy and Clinical Immunology ( EAACI ) and the Respiratory Effectiveness Group ( REG ) to develop a  quality assessment tool for real-life observational research to identify high- quality real-life asthma studies that could be considered within future guideline development .
Real life clinical study design supporting the effectiveness of extra-fine inhaled beclomethasone/formoterol at the level of small airways of asthmatics.
BACKGROUND In an attempt to establish how treatment with inhaled extra-fine beclomethasone/formoterol ( I-EF-BDP/F ) formulation differs from other combinations of inhaled corticosteroid ( ICS ) and long acting beta-agonist ( LABA ) , we studied lung function and markers of airway inflammation upon switching to the extra-fine formulation and after 8 weeks of treatment with it . METHODS We carried out a real-life clinical observation of undercontrolled asthmatic patients switched over from dry powder inhalers of fluticasone/salmeterol and budesonide/formoterol to I-EF-BDP/F  ( Foster ( ® ) , Chiesi Farmaceutici S.p . A. , Italy ) . The effects of 8-weeks of treatment were documented by means of visual analog scale ( VAS ) , quality of life by Asthma Quality of Life Question naire ( AQLQ ) , spirometry and markers of airway or systemic inflammation : exhaled breath temperature ( EBT ) , blood eosinophils ( Eos ) , and high sensitivity C-reactive protein ( CRP ) . Before/after treatment differences between forced vital capacity percent of predicted ( % FVC ) , a simple indicator of small airways involvement , were calculated and subjects were ranked accordingly to reflect the magnitude of the therapeutic response . Subjects above the 75th percentile ( n = 15 ) , " top responders " , were then compared with those below the 25th percentile ( n = 15 ) " poor responders " . RESULTS On average , the 59 patients completing the study ( mean age ± SD 51 ± 12 years , 38 women ) had significant improvement in VAS and QLQ scores at the end of the treatment period ( 49.1 ± 2.4 vs. 73.1 ± 2.05 and 146.1 ± 2.7 vs. 176.7.1 ± 3.4 respectively , P < 0.001 ) , but not in the inflammatory indicators ( EBT , CRP and Eos ) . However , when comparing the " top responders " with the " poor responders " , significant improvement in these inflammatory indicators was observed : EBT significantly decreased from 34.04/mean/± 0.30/s.e.m./[ ° C ] to 33.57 ± 0.33 , P = 0.003 , Eos in blood fell from 381.7 ± 91.2 [ cells/μL ] to 244.2 ± 43.2 , P = 0.02 . Before/after treatment differences in hsCRP decreased significantly in the top responders compared with the poor responders ( Mann-Whitney test , P = 0.04 ) . CONCLUSION Asthmatic subjects who had the most improvement in FVC after transition to  I-EF-BDP/F  from other combined ICS/LABA preparations also demonstrated a significant decrease in some indicators of airway/systemic inflammation . These results support the notion that I-EF-BDP/F exerts an effect also at the level of the small airways through a reduction of the level of air trapping . Patients in whom inflammation of the small airways plays an important clinical role are the ones to derive most benefit from this small airways tailored treatment . However , improved compliance due to the " promise of a new drug " effect should also be considered as contributing to the treatment results
Results Although highlighting a general lack of high- quality real-life effectiveness observational research on these clinical ly important topics , the analysis provided insights into how identified observational studies might inform asthma guidelines developers and clinicians .
Overall , RELEVANT appeared reliable and easy to use by expert review ers .
Conclusions Using such quality appraisal tools is m and atory to assess whether specific observational real-life effectiveness studies can be used to inform guideline development and /or decision-making in clinical practice
Abstract Introduction A Task Force was commissioned jointly by the European Academy of Allergy and Clinical Immunology ( EAACI ) and the Respiratory Effectiveness Group ( REG ) to develop a  quality assessment tool for real-life observational research to identify high- quality real-life asthma studies that could be considered within future guideline development .