Background
Methods
Participants and study design
Randomization and intervention
Outcomes and follow-up
Microbiological response
Sample size and statistical analyses
Results
Baseline characteristics
Characteristics | Monotherapy (n = 79) | Combination therapy (n = 60) | P-value# |
---|---|---|---|
Age, years | 71.4 ± 11.8 | 71.7 ± 12.1 | 0.89 |
Male sex, no. (%) | 55 (69.6) | 46 (76.7) | 0.36 |
Smokers, no. (%) | 43 (54.4) | 34 (56.7) | 0.79 |
Body mass index ± SD | 24.1 ± 3.1 | 23.7 ± 2.6 | 0.25 |
VAS score | 34.1 ± 11.1 | 32.3 ± 16.1 | 0.54 |
Percent predicted FEV1, %† | 58.0 ± 14.8 | 55.8 ± 16.1 | 0.42 |
Percent predicted FVC, %† | 71.3 ± 17.1 | 72.1 ± 18.2 | 0.47 |
Comorbidities, no. (%) | |||
Ischemic heart disease | 31 (39.2) | 27 (45.0) | 0.52 |
Heart failure | 20 (25.3) | 13 (21.7) | 0.63 |
Diabetes mellitus | 11 (13.9) | 10 (16.7) | 0.46 |
Lung cancer | 2 (2.5) | 6 (10.0) | 0.21 |
WBC | |||
1. > 10 × 109/L, no. (%) | 42 (53.1) | 34 (56.7) | 0.52 |
C-reactive protein (mg/L), median (IQR) | 46.0 (12–124) | 44.8 (18–113) | 0.73 |
PaO2 (mm Hg), median (IQRs) | 71.7 (41–99) | 72.8 (43–115) | 0.72 |
PaCO2 (mm Hg), median (IQRs) | 42.8 (27–90) | 40.9 (25–82) | 0.45 |
ICS, no. (%) | 76 (96.2) | 59 (98.3) | 0.08 |
SCS, course for current AECOPD, no. (%) | 30 (37.9) | 22 (36.7) | 0.34 |
Primary outcome
End Point | Monotherapy (n = 79) | Combination therapy (n = 60) | P-value# |
---|---|---|---|
Clinical success on Day 10, no. (%) | 48 (60.7) | 36 (60) | 1 |
Clinical success on Day 20, no. (%) | 70(88.6) | 53 (88.3) | 1 |
FEV1, L | |||
FEV1 on Day 1 | 0.75 ± 0.19 | 0.73 ± 0.21 | 0.22 |
ΔFEV1 on Day 10 | 0.17 ± 0.21 | 0.20 ± 0.26 | 0.24 |
ΔFEV1 on Day 20 | 0.18 ± 0.28 | 0.24 ± 0.25 | 0.56 |
VAS score | |||
ΔVAS score on Day 10 | − 10.6 ± 9.6 | − 10.5 ± 13.3 | 0.92 |
ΔVAS score on Day 20 | − 21.3 ± 15.1 | − 23.8 ± 17.6 | 0.26 |
CRP (mg/L) | |||
ΔCRP on Day 10 | − 13.5 ± 14.3 | − 12.6 ± 16.1 | 0.099 |
ΔCRP on Day 20 | − 22.1 ± 14.5 | − 26.9 ± 15.7 | 0.004 |
Secondary outcomes
Clinical outcomes on day 10
Pulmonary function
Serum CRP
Symptom scores
Microbiological outcomes
End Point | No. success (%) | Monotherapy (n = 79) | Combination therapy (n = 60) | P-value |
---|---|---|---|---|
Overall success, no. (%) | 128 (92.1) | 70 (88.6) | 58 (96.7) | 0.11 |
Success per pathogen | ||||
Streptococcus pneumoniae (n = 50) | 48 | 31/32 (96.9) | 17/18 (94.4) | 1 |
Haemophilus influenzae (n = 29) | 27 | 20/21 (95.2) | 7/8 (87.5) | 0.48 |
Pseudomonas aeruginosa (n = 18) | 16 | 1/3 (33.3) | 15/15 (100) | 0.01 |
Acinetobacter baumanii (n = 12) | 8 | 1/5 (20.0) | 7/7 (100) | 0.01 |
Stenotrophomonas maltophilia (n = 10) | 9 | 5/6 (100) | 4/4 (100) | 1 |
Staphylococcus aureus (n = 8) | 8 | 4/4 (100) | 4/4 (100) | 1 |
Escherichia coli (n = 6) | 6 | 4/4 (100) | 2/2 (100) | 1 |
Moraxella catarrhalis (n = 6) | 6 | 4/4 (100) | 2/2 (100) | 1 |