Eligibility of real-life patients with COPD for inclusion in trials of inhaled long-acting bronchodilator therapy

Respiratory Research

Table 4 Percentage^a of total OPCRD patients with COPD eligible for RCTs testing tiotropium (n = 36 893)

Step	Criterion for sequential selection	NCT02172287	NCT00274014	NCT00274547	NCT00277264	NCT00144339	NCT00387088	NCT00563381	NCT01126437	NCT01455129	Median
1	FEV₁	46.8	50.3	46.8	56.3	65.8	46.8	65.8	65.8	72.8	56.3
2	Other inclusion criteria	38.5	20.6	44.5	23.2	54.4	44.5	26.1	55.6	64.7	44.5
3	COPD-related exclusion criteria	37.8	19.9	41.6	21.8	53.4	43.8	25.8	54.4	59.8	41.6
4	Concomitant pulmonary disease	35.6	19.9	41.6	20.2	47.3	41.1	25.5	48.2	52.9	41.1
5	Asthma, allergic diseases and atopy	23.8	14.3	32.9	14.7	37.5	29.8	19.6	38.2	39.1	29.8
6	Comorbidities	16.7	11.2	30.7	9.6	28.8	27.9	15.2	29.3	31.4	27.9
7	Other relevant conditions	15.7	11.2	30.7	9.5	27.1	27.9	14.4	27.5	29.2	27.1
8	Final eligible proportion (%)	15.7	11.2	25.1	9.5	22.5	27.8	11.8	22.9	25.0	22.5

Abbreviations: COPD chronic obstructive pulmonary disease, FEV ₁ forced expiratory volume in 1 s
^aStepwise reduction of the percentage of the total number of OPCRD patients with COPD eligible for individual RCTs (columns) when applying groups of criteria (rows) sequentially. Median values for all RCTs shown in the table are listed in the last column

ISSN: 1465-993X