Table 3. Primary and Secondary End Pointsa.
| Event | Usual care + antimicrobial therapy (n = 254) | Usual care (n = 259) | Difference (95% CI) | Hazard ratio (95% CI)b | ||
|---|---|---|---|---|---|---|
| Summary statistics | Events per 100 patient-years | Summary statistics | Events per 100 patient-years | |||
| Primary end point, No. (%) | ||||||
| Death or first nonelective, respiratory hospitalization | 52 (20.5) | 20.4 (14.8 to 25.9) | 56 (21.6) | 18.4 (13.2 to 23.6) | 2.0 (−5.7 to 9.6)c | Adjusted, 1.04 (0.71 to 1.53) Unadjusted, 1.11 (0.70 to 1.78) |
| Secondary end point, No. (%) | ||||||
| Death from any cause | 37 (14.6) | 13.5 (9.5 to 18.7) | 37 (14.3) | 11.5 (8.1 to 15.9) | 2.0 (−4.1 to 8.1)c | 1.11 (0.70 to 1.78) |
| Nonelective hospitalization | ||||||
| Respiratory | 36 (14.2) | 14.1 (9.9 to 19.5) | 31 (12.0) | 10.2 (6.9 to 14.5) | 3.9 (−2.1 to 10.0)c | 1.34 (0.82 to 2.17) |
| All-cause | 54 (21.3) | 22.6 (17.0 to 29.5) | 47 (18.1) | 15.8 (11.6 to 21.1) | 6.7 (−0.9 to 14.3)c | 1.36 (0.91 to 2.01) |
| Count of nonelective hospitalizations, per 100 y | 44 (17.3) | 16.1 (11.2 to 21.0) | 36 (13.9) | 11.2 (7.2 to 15.3) | 4.9 (−1.5 to 11.3)c | RR, 1.29 (0.82 to 2.02) |
| Respiratory | ||||||
| 0 | 218 (85.8) | 228 (88.0) | ||||
| 1 | 30 (11.8) | 26 (10.0) | ||||
| 2 | 4 (1.6) | 5 (1.9) | ||||
| 3 | 2 (0.8) | 0 | ||||
| All-cause per 100 y | 72 (28.3) | 26.4 (20.0 to 32.7) | 56 (21.6) | 17.5 (12.4 to 22.6) | 8.9 (0.8 to 17.0)c | RR, 1.44 (1.00 to 2.07) |
| 0 | 200 (78.7) | 212 (81.9) | ||||
| 1 | 39 (15.4) | 40 (15.4) | ||||
| 2 | 12 (4.7) | 6 (2.3) | ||||
| 3 | 3 (1.2) | 0 | ||||
| 4 | 0 (0.0) | 1 (0.4) | ||||
| Change from randomization to 12 mo | ||||||
| FVC, median (IQR), L | −0.10 (−0.28 to 0.03) | −0.14 (−0.29 to 0.03) | 0.04 (−0.02 to 0.10)b | |||
| Dlco, median (IQR), mL·min −1·mm Hg | −0.71 (−2.10 to 0.72) | −0.83 (−2.18 to 0.24) | 0.38 (−0.10 to 0.86)b | |||
| Respiratory infections, No. (%) | 34 (12.2) | 12.4 (8.1 to 16.8) | 49 (18.9) | 15.3 (10.5 to 20.1) | −2.8 (−9.3 to 3.6)c | RR, 0.71 (0.46 to 1.11) |
| 0 | 223 (87.8) | 216 (83.4) | ||||
| 1 | 28 (11.0) | 37 (14.3) | ||||
| 2 | 3 (1.2) | 6 (2.3) | ||||
| Change from randomization to 12 mo, median (IQR) | ||||||
| Shortness of breath | 5.00 (−2.00 to 15.00) | 4.00 (−2.00 to 12.00) | 0.59 (−4.62 to 3.43)b | |||
| Fatigue severity scale | 0.22 (−0.78 to 1.11) | 0.22 (−0.56 to 1.00) | 0.10 (−0.26 to 0.46)b | |||
| Leicester cough questionnaire | −0.30 (−2.32 to 0.86) | −0.27 (−2.09 to 0.88) | −0.01 (−0.82 to 0.80)b | |||
| EQ-5D score | 0.00 (−0.14 to 0.04) | 0.00 (−0.12 to 0.00) | 0.01 (−0.04 to 0.05)b | |||
| 12-Item Short Form Health Survey | ||||||
| Mental score | −1.05 (−5.84 to 2.79) | −1.29 (−6.03 to 2.90) | 0.46 (−1.45 to 2.37)b | |||
| Physical score | −1.49 (−6.39 to 3.63) | −1.96 (−5.62 to 1.88) | 0.46 (−1.18 to 2.10)b | |||
| SF6D score | 0.00 (−0.08 to 0.06) | 0.00 (−0.10 to 0.05) | 0.02 (−0.01 to 0.04)b | |||
| ICECAP-O | 0.00 (−0.10 to 0.15) | 0.00 (−0.09 to 0.12) | 0.01 (−0.03 to 0.05)b | |||
Abbreviations: Dlco, diffusing capacity of lung for carbon monoxide; Dlco, diffusing capacity of lung for carbon monoxide; EQ-5D, 5-level EuroQol 5-dimension questionnaire; FVC, forced vital capacity; ICECAP-O, CEpop CAPability measure for Older people; IQR, interquartile range; RR, risk ratio; SF6D, Short Form Health survey.
For a definition of measures and score ranges, see the Table 1 footnotes.
Difference in events per 100 person-years for antimicrobial therapy plus usual care vs usual care: point estimate (95% CI).
The models were adjusted for the following factors: age, sex, baseline Dlco; baseline FVC, use of N-acetylcysteine at enrollment, use of nintedanib or pirfenidone at enrollment, and choice of antimicrobial agent prior to randomization.