Table 2 Eligibility criteria and related exclusion rates
Criterion | Total number of trials setting the criterion | Cut-off values of the criterion | Number of trials setting the criterion | Availability of data in Initiative BPCO database | Percentage of patients excluded by the criterion | |
|---|---|---|---|---|---|---|
Demographics | Minimum age | 16 (100%) | 40 years | 16 (100%) | yes | 1.1% |
Maximum age | 3 (18.8%) | 80 years | 2 (12.5%) | yes | 5.3% | |
85 years | 1 (6.3%) | yes | 0.8% | |||
Disease diagnosis and severity | Smoking history | 15 (93.8%) | Current or former smoker | 15 (93.8%) | yes | 4.9% |
At least 10 PY | 11 (68.8%) | yes | 17.6% | |||
At least 15 PY | 1 (6.3%) | yes | 20.2% | |||
At least 20 PY | 2 (12.5%) | yes | 25.1% | |||
Airway obstruction | 16 (100%) | FEV1/FVC < 0,7 | 16 (100%) | yes | 0% | |
Maximum FEV1a | 15 (93.8%) | 49% (GOLD 3 threshold) | 8 (50%) | yes | 54.4% | |
79% (GOLD 2 threshold) | 1 (6.3%) | yes | 9.5% | |||
70% | 3 (18.8%) | yes | 22.7% | |||
65% | 2 (12.5%) | yes | 31.2% | |||
60% | 1 (6.3%) | yes | 45% | |||
Minimum FEV1 | 1 (5.5%) | 21% | 2 (12.5%) | yes | 8.8% | |
Minimum exacerbation rate during the previous year | 14 (87.5%) | 1 event | 10 (62.5%) | yes | 36.4% | |
2 events | 4 (25%) | yes | 62.2% | |||
Maximum exacerbation rate during the previous yearb | 13 (81.3%) | 24 events | 2 (12.5%) | yes | 0% | |
12 events | 8 (50%) | yes | 0.1% | |||
9 events | 3 (18.8%) | yes | 0.8% | |||
Disease control | COPD symptoms | 4 (25%) | Evidence of chronic productive cough | 2 (12.5%) | no | Uncollected data (assumed 0%) |
mMRC score > 1 | 1 (6.3%) | |||||
CAT > 10 | 1 (6.3%) | |||||
Concomitant treatments restrictionsc | Long term oxygen therapy | 7 (43.8%) | < 12 h/day | 1 (6.3%) | use of oxygenotherapy assessed | 11.8% |
< 15 h/day | 1 (6.3%) | |||||
< 16 h/day | 1 (6.3%) | |||||
Not daily | 4 (25%) | |||||
Oral corticosteroids | 6 (37.5%) | Forbidden | 4 (25%) | Intake of OCS assessed | 3.0% | |
< 10 mg/day | 2 (12.5%) | |||||
Previous participation in a pulmonary rehabilitation program | 3 (18.8%) | Forbidden | 3 (18.8%) | no | Uncollected data (assumed 0%) | |
Comorbidities restrictionsd | Concomitant pulmonary diseases | 15 (93.8%) | Forbidden | 15 (93.8%) | Only asthma assessed | 13.1% |
History of pulmonary surgery | 7 (43.8%) | Lobectomy | 4 (25%) | Only transplantation assessed | 0% | |
Lung volume reduction | 6 (37.5%) | |||||
Transplantation | 2 (12.5%) | |||||
History of cancer | 8 (50%) | Forbidden | 1 (6.3%) | no | Uncollected data (assumed 0%) | |
Forbidden if within 1 year | 1 (6.3%) | |||||
Forbidden if within 5 years | 6 (37.5%) | |||||
Cardiovascular comorbidities (including arterial hypertension, heart failure, myocardial infarction and arrythmias) | 10 (62.5%) | Forbidden | 10 (62.5%) | Cardiovascular comorbidities assessed | 16.1% | |
Endocrine disorders | 5 (31.3%) | No diabetes | 2 (12.5%) | yes | 13.6% | |
No thyrotoxicosis | 3 (18.8%) | No | Uncollected data(assumed 0%) | |||
No obesity (BMI > 45 kg/m2) | 1 (6.3%) | No | Uncollected data(assumed 0%) | |||
Renal impairement | 4 (22.2%) | No moderate or severe renal failure | 3 (18.8%) | No | Uncollected data(assumed 0%) | |
Allergic status | 3 (18.8%) | No atopic status | 2 (12.5%) | yes | 11% | |
No allergic rhinitis | 3 (18.8%) | yes | 21.2% | |||
History or current drug or alcohol abuse | 8 (50%) | Forbidden | 8 (504%) | No | Uncollected data(assumed 0%) | |
Compliance | History of poor compliance to medication prescription | 3 (18.8%) | Forbidden | 3 (18.8%) | No | Uncollected data(assumed 0%) |
Pregnancy and breastfeeding | Pregnancy and breastfeeding | 8 (50%) | Forbidden | 8 (50%) | No | Uncollected data (assumed 0%) |