Table 1. Demographics and baseline characteristics of the ITT population (N=397).
| Parameter | Patients 6–17 years of age with asthma (n=110) | Patients ≥18 years of age with asthma (n=190) | Patients with COPD (n=97) |
|---|---|---|---|
| Sex (female), n (%) | 50 (45.5) | 129 (67.9) | 45 (46.4) |
| Mean age, years (range) | 9.3 (6.0–17.0) | 59.1 (19.0–88.0) | 65.9 (47.0–82.0) |
| Mean height, cm (range) | 137.4 (112.5–179.5) | 166.7 (146.0–194.0) | 167.3 (148.0–186.0) |
| Mean weight, kg (range) | 34.9 (19.0–88.5) | 78.7 (47.0–140.0) | 74.3 (42.0–140.0) |
| Mean BMI, kg/m2 (range) | 17.9 (12.8–29.6) | 28.3 (18.6–50.6) | 26.5 (15.2–42.7) |
| Race, n (%) | |||
| Asian | 1 (0.9) | 0 (0) | 0 (0) |
| Black | 1 (0.9) | 0 (0) | 0 (0) |
| Caucasian | 107 (97.3) | 190 (100.0) | 97 (100.0) |
| Other | 1 (0.9) | 0 (0) | 0 (0) |
| Previous/current use of nicotine products, n (%) | |||
| Never used | 108 (98.2) | 125 (65.8) | 3 (3.1) |
| Past user | 0 (0) | 44 (23.2) | 49 (50.5) |
| Irregular user | 0 (0) | 3 (1.6) | 1 (1.0) |
| Regular user | 2 (1.8) | 18 (9.5) | 44 (45.4) |
| Respiratory, thoracic and mediastinal disorders, n (%) | |||
| Asthma | 110 (100.0) | 190 (100.0) | 13 (13.4) |
| COPD | 0 (0) | 8 (4.2) | 97 (100.0) |
| Allergic rhinitis | 45 (40.9) | 26 (13.7) | 0 (0) |
| Pulmonary embolism | 0 (0) | 4 (2.1) | 0 (0) |
| FEV1, L (range) | 1.9 (0.5–4.7) | 2.3 (0.6–5.0) | 1.4 (0.4–3.3) |
| FEV1, % predicted (range) | 96.9 (35.0–138.4) | 79.4 (30.5–164.0) | 49.9 (14.0–92.0) |
| FVC, L (range) | 2.3 (0.9–5.7) | 3.1 (0.9–7.1) | 2.5 (0.9–5.7) |
| FVC, % predicted (range) | 99.6 (51.0–138.0) | 88.1 (40.0–149.0) | 72.9 (29.0–133.0) |
| Native PIF, L/s (range) | 3.0 (0.3–6.8) | 5.0 (1.2–11.5) | 4.3 (1.2–8.6) |
| PEF, L/s (range) | 4.0 (1.0–10.2) | 6.1 (2.0–12.8) | 3.9 (1.4–9.5) |
| Previous/concomitant respiratory treatments, n (%) | |||
| All treatments | 105 (95.5) | 188 (98.9) | 96 (99.0) |
| Drugs for obstructive airway diseases | 103 (93.6) | 186 (97.9) | 92 (94.8) |
| Nasal preparations | 21 (19.1) | 17 (8.9) | 0 (0) |
| Antihistamines for systemic use | 37 (33.6) | 10 (5.3) | 2 (2.1) |
| Cough and cold preparations | 0 (0) | 1 (0.5) | 1 (1.0) |
BMI, body mass index; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; ITT, intent-to-treat; PEF, peak expiratory flow; PIF, peak inspiratory flow.