Figure 1.

Studies have shown that classical efficacy RCTs exclude about 90% for a) asthma and 95% for b) COPD routine care populations due to strict inclusion and exclusion criteria. a) For asthma clinical-trial patients criteria included: visual analogue scale (VAS) <2; historical reversibility in FEV 12% within the last 12 months; absence of significant co-morbidity; nonsmoker or if previous smoker (XS) a smoke burden <10 pack-years; regular use of ICS; symptomatic asthma (defined as either the use of short acting β2-agonist daily or nocturnal awakening due to asthma at least once a week). b) For COPD clinical-trial patients criteria included: VAS >7.5, absence of significant co-morbidity; smoker (S) or XS; a smoke burden of >15 pack-years; no history of hay fever indicating presence of atopy. Reproduced from [5] with permission from the publisher.