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. 2011 Sep 17;11(6):526–538. doi: 10.1007/s11882-011-0222-7

Table 2.

Representative nature of cRCTs in asthma: percentage of real world patients with an asthma diagnosis who meet typical cRCT inclusion criteria

Criterion for inclusion in respiratory cRCT Patients with clinical asthma eligible for cRCTs,%
Travers et al. [18] Herland et al. [20]
Lung function diagnostic criteria outlined by GINA Bronchodilator reversibility ≥12% 29 14.9
Peak flow variability ≥20% 44
Additional inclusion criteria typically used in asthma cRCTs Bronchodilator reversibility ≥15% 24
FEV1 ≥50% and <80% of predicted 39
FEV1 ≥50% and <85% of predicted 37.1
Regular inhaled corticosteroid use 52 3.3
Nonsmoker or <10 pack-years of exposure to cigarette 71 5.4
Active symptoms or use of rescue drugs 80 4.5
FEV1 ≥50% predicted 88
No comorbidities 9.6

cRCT classical randomized controlled trial, FEV 1 forced expiratory volume in 1 s, GINA Global Initiative for Asthma

(Adapted from GINA [3], Travers et al. [18], and Herland et al. [20])