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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