Table 1.
Demographic Data, Current Diseases, and Previous Inhalation Devices Used at Baseline
| Age group (years) | |||||
|---|---|---|---|---|---|
| All | 0 to <2 | 2 to <3 | 3 to <4 | 4 to <5 | |
| Number of patients | 103 | 25 | 20 | 30 | 28 |
| Males | 65 (63) | 18 (72) | 11 (55) | 17 (57) | 19 (68) |
| Race | |||||
| Caucasian (European) | 90 (87) | 23 (92) | 16 (80) | 24 (80) | 27 (96) |
| Caucasian (non-European) | 1 (1) | 1 (4) | 0 (0) | 0 (0) | 0 (0) |
| Asian | 9 (9) | 0 (0) | 2 (10) | 6 (20) | 1 (4) |
| Black | 3 (3) | 1 (4) | 2 (10) | 0 (0) | 0 (0) |
| Diagnosis | |||||
| Preschool asthma | 67 (65) | 17 (68) | 12 (60) | 17 (57) | 21 (75) |
| Recurrent bronchitis | 26 (25) | 6 (24) | 5 (25) | 12 (40) | 3 (11) |
| Cystic fibrosis | 10 (10) | 2 (8) | 3 (15) | 1 (3) | 4 (14) |
| Device* | 197 | 44 (100) | 34 (100) | 66 (100) | 53 (100) |
| No device | – | 9 (21) | 3 (9) | 14 (21) | 16 (13) |
| Nebulizer | – | – | 8 (24) | 9 (14) | 9 (17) |
| Nebulizer+mask | – | 31 (71) | 18 (53) | 21 (32) | 11 (21) |
| pMDI | – | – | – | 2 (3) | 5 (9) |
| pMDI+VHC | – | – | 1 (3) | 5 (8) | 5 (9) |
| pMDI+VHC+mask | – | 4 (9) | 4 (12) | 15 (23) | 7 (13) |
All data are n (%).The safety data set as well as the full analysis data set consisted of all (N=103) patients. Four patients had protocol violations and so were excluded from the per protocol data set (N=99). *Results are inclusive of patients who may have used more than one device.
pMDI, pressurized metered dose inhaler.