Table 3.
Phase I safety data.
| Baseline | 1 h post | 4 h post | p value | |||||
|---|---|---|---|---|---|---|---|---|
| Sound | No sound | Sound | No sound | Sound | p value | No sound | ||
| FVC (l) | 4.1 (2.8–4.8) | 4.1 (2.8–4.8) | 4.0 (2.8–4.7) | 4.0 (2.9–4.8) | 4.0 (2.6–4.7) | 0.25 | 4.0 (2.5–4.7) | 0.38 |
| FVC (% pred) | 90 (74–98) | 88 (76–100) | 89 (76–99) | 88 (71–98) | 90 (71–98) | 0.22 | 90 (67–97) | 0.46 |
| FEV1 (l/s) | 2.6 (1.4–3.2) | 2.6 (1.4–3.4) | 2.6 (1.4–3.3) | 2.7 (1.4–3.3) | 2.5 (1.3–3.1) | 0.13 | 2.7 (1.3–3.3) | 0.43 |
| FEV1 (%) | 72 (45–89) | 77 (47–91) | 68 (47–89) | 77 (47–94) | 69 (43–89) | 0.11 | 74 (40–92) | 0.40 |
| FEV1/FVC (%) | 61 (53–73) | 64 (55–75) | 60 (54–74) | 64 (56–75) | 61 (53–73) | 0.71 | 64 (56–75) | 0.59 |
| FEF25–75 (l/s) | 1.1 (0.5–2.6) | 1.4 (0.6–2.7) | 1.1 (0.5–2.7) | 1.5 (0.5–2.6) | 1.1 (0.5–2.5) | 0.053 | 1.4 (0.5–2.7) | 0.26 |
| FEF25–75 (%) | 30 (13–65) | 36 (15–69) | 28 (15–66) | 38 (14–65) | 27 (15–61) | 0.09 | 36 (13–67) | 0.48 |
| SpO2 (%) | 97 (96–98) | 98 (97–98) | 97 (97–98) | 98 (97–99) | 98 (96–99) | 0.41 | 98 (97–98) | 0.59 |
| Cardiac output (l/min) | 4.1 (2.6–5.6) | 3.9 (2.7–5.4) | 3.7 (2.5–4.8) | 3.6 (2.9–4.2) | 3.6 (2.5–4.7) | 0.19 | 3.4 (2.8–3.8) | 0.13 |
| HR (bpm) | 89 (83–104) | 95 (81–115) | 90 (79–96) | 89 (77–117) | 88 (78–99) | 0.24 | 89 (79–113) | 0.02 |
| Stroke volume (ml) | 43 (29–59) | 38 (28–66) | 36 (31–54) | 36 (27–52) | 39 (28–58) | 0.38 | 32 (31–45) | 0.16 |
| DLCO (l/min/mmHg) | 15.8 (12.4–18.3) | 14.9 (12.1–16.9) | 14.1 (11.8–16.6) | 15.0 (12.2–19.7) | 14.7 (11.8–16.3) | 0.06 | 16.4 (12.7–19.7) | 0.047 |
| DM (l/min/mmHg) | 25.5 (17.9–28.4) | 24.1 (18.2–28.2) | 23.2 (18.1–26.4) | 26.0 (20–30) | 23.9 (18.4–26.5) | 0.19 | 25.9 (19.1–36.2) | 0.047 |
| VC (ml) | 32.9 (27.9–42.5) | 30.3 (24.6–42.6) | 33.6 (25.4–34.1) | 27.7 (23.9–41.7) | 32.3 (26.6–35.7) | 0.07 | 28.2 (24.4–33.5) | 0.38 |
| DM/VC | 0.72 (0.57–0.76) | 0.68 (0.54–0.88) | 0.75 (0.67–0.82) | 0.82 (0.63–0.92) | 0.76 (0.68–0.82) | 0.04 | 0.72 (0.68–1.05) | 0.28 |
Values are median (interquartile range). p values represent Wilcoxon signed ranks baseline versus 4 h post for each treatment.
SpO2, peripheral oxygen saturation; DLCO, diffusion capacity of the lungs for carbon monoxide; DM, alveolar–capillary membrane conductance; VC, pulmonary–capillary blood volume; DM/VC, functional unit of diffusion; FVC, forced vital capacity; FEV1, forced expiratory volume at 1 s of the FVC; FEF25–75, forced expiratory volume at 25–75% of the FVC; HR, heart rate; bpm, beats per min.