Table 2.
Drug Deposition Parameters in the Two Populations, and Statistical Comparison Between Healthy Volunteers and Patients with Asthma (Intention-to-Treat Population)
| Parameter | Healthy volunteers (N = 10) | Asthma (N = 9) | Adjusted mean difference (95% CI) [p] |
|---|---|---|---|
| Intrapulmonary drug deposition (% of nominal dose) | 22.74 ± 9.19 | 25.50 ± 6.81 | 2.76 (−5.15, 10.67) [0.4715] |
| Aerosol (99mTc) central to peripheral lung region ratio (C/P) | 0.94 ± 0.25 | 1.06 ± 0.25 | 0.12 (−0.12, 0.36) [0.3024] |
| Ventilation gas (81mKr) central to peripheral lung region ratio | 0.52 ± 0.05 | 0.55 ± 0.10 | 0.04 (−0.04, 0.11) [0.3412] |
| Standardized central to peripheral ratio (sC/P) | 1.80 ± 0.40 | 1.94 ± 0.38 | 0.13 (−0.24, 0.51) [0.4636] |
| Fraction of lung dose deposited in the central lung region | 0.48 ± 0.07 | 0.51 ± 0.06 | 0.03 (−0.03, 0.09) [0.2929] |
| Fraction of lung dose deposited in the peripheral lung region | 0.52 ± 0.07 | 0.49 ± 0.06 | −0.03 (−0.09, 0.03) [0.2929] |
| Extrathoracic deposition (% of nominal dose) | 61.60 ± 10.33 | 60.65 ± 7.16 | −0.95 (−9.65, 7.76) [0.8210] |
| Amount of exhaled drug (% of nominal dose) | 2.46 ± 1.27 | 2.03 ± 1.07 | −0.42 (−1.57, 0.72) [0.4454] |
| Drug remaining in the actuator (% of nominal dose) | 13.20 ± 2.14 | 11.81 ± 1.12 | −1.39 (−3.07, 0.30) [0.1002] |
Data for the individual populations are mean ± SD.
99m
Tc, technetium-99m; 81mKr, krypton-81m.