Active | Placebo | Difference (95% CI) | p Value | |
∆FENO | −4.88 (−9.3 to −0.4) | 2.82 (−3.5 to 9.2) | −7.13 (−13.6 to −0.7) | 0.03 |
∆FENO (high baseline FENO)* | −27.30 (−37.6 to −17.0) | −2.53 (−24.0 to 18.9) | −29.70 (−47.2 to −12.2) | 0.001 |
∆ Eosinophil count (%) | −0.06 (−0.15 to 0.03) | −0.02 (−0.12 to 0.07) | −0.04 (−0.20 to 0.08) | 0.42 |
∆ FEV1 (% predicted) | −0.1 (−1.6 to 1.4) | 1.4 (−0.9 to 3.6) | −2.1 (−4.6 to 0.5) | 0.11 |
∆ PEF (% predicted) | 2.6 (0.5 to 4.6) | 5.1 (2.1 to 8.1) | −2.2 (−5.6 to 1.2) | 0.20 |
∆ FEF50 (% predicted) | −4.7 (−8.8 to −0.5) | −5.2 (−11.6 to 1.2) | −2.0 (−8.4 to 4.5) | 0.55 |
Total IgE | 4.6 (−3.5 to 12.6) | 3.7 (−4.1 to 11.5) | 2.9 (−9.9 to 15.7) | 0.66 |
∆ Cat-specific IgE | 8.2 (−0.4 to 16.7) | 35.4 (17.8 to 53.0) | −26.0 (−44.1 to −7.9) | 0.005 |
∆ Dog-specific IgE | −1.9 (−10.4 to 6.5) | 13.9 (−10.0 to 38.2) | −14.6 (−36.5 to 7.3) | 0.19 |
∆ Dust mite specific IgE | ||||
Der. farinae | 3.5 (−6.2 to 13.2) | 13.6 (−0.7 to 27.9) | −8.2 (−25.9 to 9.5) | 0.36 |
Der. pteronyssinus | −2.6 (−9.7 to −4.5) | 7.2 (−5.4 to 19.8) | −6.4 (−20.1 to 7.3) | 0.36 |
All data were calculated using last observation carried forward to impute missing values. Data are expressed as mean (95% CI) absolute changes in FENO (ppb), eosinophil count (as % of total white cell count) and lung function variables (as % predicted value), and mean (95% CI) percentage change in total or specific IgE levels (kU/litre) relative to baseline level over the 1-year study period.
↵* Analysis of change in FENO in the subgroup of patients with abnormally raised FENO (>45 ppb) at baseline. In this group the mean (SD) baseline FENO in ppb was active 81.8 (44.2; n=56) and placebo 80.8 (32.3; n=23). For specific and total IgE and eosinophil counts, n=175 active, 91 placebo; for all other analyses, n=189 active, 93 placebo.
Der. farinae, Dermatophagoides farina; Der. pteronyssinus, Dermatophagoides pteronyssinus; FEF50, forced expiratory flow at 50% of vital capacity; FENO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 s; PEF, peak expiratory flow.