Table 1.
Baseline Demographic and Clinical Characteristics in the Intention-to-Treat Population
| Placebo (n = 19) |
HDM-SLIT (n = 20) |
Total (n = 39) |
|
|---|---|---|---|
| Age, yr | 28 ± 8.8 | 28 ± 7.3 | 28 ± 8.0 |
| Female | 12 (63) | 13 (65) | 25 (64) |
| BMI, kg/m2 | 24 ± 4.7 | 23 ± 3.8 | 24 ± 4.2 |
| Ex-smoker | 8 (42) | 5 (25) | 13 (33) |
| Pack-years | 1 (1–8) | 2.5 (1–6) | 1.5 (1–8) |
| ACQ-6 score | 1.8 ± 0.65 | 1.7 ± 0.64 | 1.8 ± 0.64 |
| RQLQ score | 1.74 ± 0.8 | 1.83 ± 1.02 | 1.78 ± 0.91 |
| Prebronchodilator FEV1, L | 3.7 ± 0.71 | 3.6 ± 0.82 | 3.7 ± 0.76 |
| Prebronchodilator FEV1, % predicted | 95 ± 12 | 90 ± 13 | 93 ± 12 |
| FEV1/FVC | 0.80 ± 0.077 | 0.77 ± 0.078 | 0.79 ± 0.077 |
| FEV1 reversibility, % increase | −0.30 ± 5.1 | 4.2 ± 6.0 | 2.0 ± 6 |
| FeNO, ppb | 17 (6–59) | 18 (5–69) | 18 (5–69) |
| Mannitol test, positive | 10 (53) | 13 (65) | 23 (59) |
| PD15 mannitol, mg | 241 (82–461) | 297 (43–584) | 249 (43–584) |
| Monosensitized, HDM | 5 (26) | 6 (30) | 11 (28) |
| Polysensitized | 14 (74) | 14 (70) | 28 (72) |
| Total IgE, kUa ⋅ L−1 | 122 (22.0–361) | 138 (12.0–628) | 130 (12.0–628) |
| IgE Der-p, kUa ⋅ L−1 | 7.12 (0.36–55.7) | 11.6 (0.34–58.1) | 9.13 (0.34–58.1) |
| IgE Der-f, kUa ⋅ L−1 | 7.12 (0.38–73.9) | 12.4 (0.34–150) | 9.46 (0.34–150) |
| Blood eosinophils, ×109 ⋅ L−1 | 0.14 (0.02–0.46) | 0.16 (0.04–0.05) | 0.15 (0.02–0.53) |
| Blood eosinophils ⩾ 0.25 × 109 ⋅ L−1 and/or sputum eosinophils ⩾ 3% | 5 (26) | 5 (25) | 10 (26) |
| ICS total equivalent budesonide dose, μg | 1,020 (400–1,600)* | 736 (400–1,600) | 862 (400–1,600) |
| Asthma severity, high ICS d.d.d. | 8 (42) | 4 (20) | 12 (31) |
| Adherence to primary controller in past 365 days, % | 77 (12–100) | 74 (9–100) | 75 (9–100) |
| More than one exacerbation in ⩽12 mo | 2 (11) | 0 (0) | 2 (5.1) |
| ICS | 5 (26) | 4 (20) | 9 (23) |
| ICS/LABA | 18 (95) | 16 (80) | 34 (87) |
| INCS | 13 (68) | 14 (70) | 27 (69) |
| Antihistamine | 17 (90) | 15 (75) | 32 (36) |
| Ocular antihistamine | 6 (32) | 8 (40) | 14 (36) |
| SABA as needed, puffs/d | 1.3 ± 1.11 | 0.86 ± 1.2 | 1.05 ± 1.14 |
Definition of abbreviations: ACQ-6 = Asthma Control Questionnaire; BMI = body mass index; d.d.d. = daily dose delivered; FeNO = fractional exhaled nitric oxide; HDM = house dust mite; ICS = inhaled corticosteroid; INCS = intranasal corticosteroid; LABA = long-acting β2 agonist; PD15 = provoking dose of mannitol causing a 15% reduction in FEV1; RQLQ = Rhinoconjunctivitis Quality of Life Questionnaire; SABA = short-acting β2 agonist; SLIT = sublingual allergen immunotherapy.
Data are presented as mean ± SD, n (%), or geometric mean (range).
*
Statistically significant.