Demographic and baseline characteristics
| AIR-BX1 | AIR-BX2 | ||||||
|---|---|---|---|---|---|---|---|
| AZLI (N=134) | Placebo (N=132) | p Value* | AZLI (N=136) | Placebo (N=138) | p Value* | ||
| Age, years; mean (SD) | 64.2 (12.9) | 64.9 (12.1) | 0.65 | 63.3 (14.2) | 62.7 (13.3) | 0.75 | |
| Age, years; range | 23–83 | 20–88 | 22–85 | 18–87 | |||
| FEV1% predicted, mean (SD) | 60.4 (22.6) | 64.5 (18.7) | 0.11 | 63.8 (19.5) | 63.4 (21.6) | 0.88 | |
| Range | 18.1–109.4 | 20.6–114.1 | 22.7–115.5 | 19.5–115.3 | |||
| <50% predicted, n (%) | 52 (38.8) | 33 (25.0) | 37 (27.2) | 42 (30.4) | |||
| ≥50 to <80% predicted, n (%) | 49 (36.6) | 70 (53.0) | 0.017 | 72 (52.9) | 61 (44.2) | 0.32 | |
| ≥80% predicted, n (%) | 33 (24.6) | 29 (22.0) | 27 (19.9) | 35 (25.4) | |||
| BMI, mean (SD) | 25.0 (5.1) | 24.7 (4.9) | 0.66 | 23.9 (5.0) | 24.7 (6.0) | 0.25 | |
| Female, n (%) | 84 (62.7) | 97 (73.5) | 0.07 | 89 (65.4) | 101 (73.2) | 0.19 | |
| Target Gram-negative pathogen at baseline,† n (%) | 131 (97.8) | 129 (97.7) | 1.0 | 135 (100)‡ | 136 (99.3)‡ | 0.62 | |
| 6MWT, metres; mean (SD) | 421 (119.3) | 426 (118.5) | 0.74 | 423 (127.5) | 428 (120.8) | 0.75 | |
| EQ-5D visual analogue score at baseline,§ mean (SD) | 66.1 (18.1) | 69.9 (16.5) | 0.08 | 65.7 (16.0) | 68.0 (14.9) | 0.23 | |
| QOL-B V.3.0 Scales: scores at baseline; mean (SD), range | |||||||
| Points for change of 1 answer category for 1 item¶ | |||||||
| Respiratory Symptoms | 3.7 | 55.0 (19.3) 3.7–96.3 | 55.5 (19.3) 0–96.3 | 0.82 | 56.2 (18.0) 7.4–95.8 | 57.4 (18.1) 0–96.3 | 0.60 |
| Physical Functioning | 6.7 | 51.6 (30.5) 0–100 | 55.7 (29.7) 0–100 | 0.27 | 49.7 (30.1) 0–100 | 47.9 (28.8) 0–100 | 0.61 |
| Vitality | 11.1 | 50.4 (20.6) 0–100 | 49.5 (21.4) 0–100 | 0.72 | 50.6 (23.0) 0–100 | 49.3 (19.3) 0–100 | 0.60 |
| Role Functioning | 6.7 | 62.9 (25.0) 0–100 | 64.7 (24.4) 13.3–100 | 0.53 | 61.3 (26.6) 0–100 | 63.3 (26.5) 0–100 | 0.51 |
| Health Perceptions | 8.3 | 44.6 (20.6) 0–100 | 47.3 (22.1) 0–91.7 | 0.30 | 43.9 (20.1) 0–91.7 | 42.9 (20.5) 0–91.7 | 0.67 |
| Emotional Functioning | 8.3 | 78.3 (20.4) 8.3–100 | 78.4 (20.1) 25.0–100 | 0.98 | 77.5 (22.4) 0–100 | 76.9 (19.2) 8.3–100 | 0.80 |
| Social Functioning | 8.3 | 54.8 (26.0) 0–100 | 51.3 (27.2) 0–100 | 0.28 | 55.3 (27.2) 0–100 | 54.6 (27.4) 0–100 | 0.83 |
| Treatment Burden** | 11.1 | 65.6 (24.0) 0–100 | 66.8 (24.7) 0–100 | 0.70 | 63.2 (23.8) 0–100 | 66.7 (23.7) 0–100 | 0.25 |
*Arms compared with t test for continuous and Fisher's exact test for categorical variables.
†Target Gram-negative respiratory pathogens at baseline (day −14 or day 1) included: Achromobacter, Burkholderia, Citrobacter, Enterobacter, Escherichia, Klebsiella, Moraxella, Proteus, Pseudomonas, Serratia or Stenotrophomonas sp.
‡Data available for 135 (AZLI) and 137 (placebo) patients.
§Data available for AIR-BX1: 131 (AZLI), 131 (placebo); AIR-BX2: 133(AZLI), 134 (placebo).
¶After standardising scores on a 100-point scale; assuming there were no missing responses on the scale.
**Data available for AIR-BX1: 127 (AZLI), 120 (placebo); AIR-BX2: 121 (AZLI), 126 (placebo); patients who were not currently receiving treatment for bronchiectasis were instructed to skip this scale.
6MWT, 6 min walk test; AZLI, aztreonam for inhalation solution; BMI, body mass index; EQ-5D, Euro Quality of Life-5 Dimensions; QOL-B, Quality of Life-Bronchiectasis.