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Table 1 Summary of clinical trials included in these analyses

From: Circulating neutrophils levels are a predictor of pneumonia risk in chronic obstructive pulmonary disease

  ITT patients (N) Trial duration (weeks) Treatment arms Primary endpoint
Dransfield et al.
HZC102871 (NCT01009463) [18]
1622 52 FF/VI: 50/25 μg, 100/25 μg, 200/25 μg (QD)
VI: 25 μg (QD)
Annual rate of moderate and severe COPD exacerbations
Dransfield et al.
HZC102970 (NCT01017952) [18]
1633 52 FF/VI: 50/25 μg, 100/25 μg, 200/25 μg (QD)
VI: 25 μg (QD)
Annual rate of moderate and severe COPD exacerbations
Kerwin et al.
HZC112206 (NCT01053988) [19]
1030 24 FF/VI: 50/25 μg, 100/25 μg (QD)
FF: 100 μg (QD)
VI: 25 μg (QD)
Change from baseline in weighted mean FEV1 over 0–4 h post-dose at Day 168; Change from baseline in clinic visit trough (pre-bronchodilator and predose) FEV1 at Day 169
INSPIRE
SCO40036
(NCT00361959) [9]
1323 104 FP/SAL: 500/50 μg (BD)
TIO: 18 μg (QD)
Rate of healthcare-utilization-based exacerbations of COPD
TRISTAN
SFCB3024 [20, 21]
1465 52 FP/SAL: 500/50 μg (BD)
FP: 500 μg (BD)
SAL: 50 μg (BD)
Pre-bronchodilator FEV1 at Week 52
Martinez et al.
HZC112207 (NCT01054885) [22]
1224 24 FF/VI: 100/25 μg, 200/25 μg (QD)
FF: 100 μg, 200 μg (QD)
VI: 25 μg (QD)
Change from baseline in weighted mean FEV1 over 0–4 h post-dose at Day 168; change from baseline in trough FEV1 at Day 169
SCO100470 [23] 1050 24 FP/SAL: 250/50 μg (BD)
SAL: 50 μg (BD)
Mean trough FEV1 at endpoint*, mean TDI focal score at endpoint*
SCO30002 [24] 387 52 FP/SAL: 500/50 μg (BD)
FP: 500 μg (BD)
Time from the start of treatment to the first moderate or severe exacerbation
Mahler et al.
SFCA3006 [25]
674 24 FP/SAL: 500/50 μg (BD)
FP: 500 μg (BD)
SAL: 50 μg (BD)
Mean change from baseline in AM pre-dose and 2-h post-dose FEV1
Hanania et al.
SFCA3007 [26, 27]
723 24 FP/SAL: 250/50 μg (BD)
FP: 250/50 μg (BD)
SAL: 50 μg (BD)
Mean change from baseline in AM pre-dose and 2-h post-dose FEV1
  1. Definition of abbreviations: AM morning; BD twice daily; BDI Baseline Dyspnoea Index; CBSQ Chronic Bronchitis Symptoms Questionnaire; CRDQ Chronic Respiratory Disease Questionnaire; CRQ-SAS Chronic Respiratory Questionnaire Self-Administered Standardized; FEV1 forced expiratory volume in 1 s; FF fluticasone furoate; FP fluticasone propionate; FVC forced vital capacity; ITT intent-to-treat; QD once daily; SAL salmeterol; SGRQ St George’s Respiratory Questionnaire; TDI Transition Dyspnoea Index
  2. *Last available on-treatment value