Comparison of withdrawal and usual care groups at 3 and 6 months: lung function, quality of life, breathlessness, blood eosinophil count, fractional exhaled nitric oxide and blood periostin concentration (Mann-Whitney U test or t-test)
| Measure | 3 months | 6 months | ||||
| Withdrawal n=19 | Usual care n=19 | P value | Withdrawal n=19 | Usual care n=19 | P value | |
| FEV1 % predicted: mean (SD)* | 70.95 (±18.22) | 73.94 (±15.13) | 0.59 | 72.00 (±16.59) | 71.63 (±12.63) | 0.94 |
| FEV1/FVC: mean (SD)* | 0.66 (±0.09) | 0.64 (±0.13) | 0.72 | 0.68 (±0.11) | 0.66 (±0.12) | 0.49 |
| AECOPD during trial: mean (SD)* | 0.20 (±0.41) | 0.10 (±0.31) | 0.39 | 0.15 (±0.37) | 0.05 (±0.22) | 0.30 |
| CAT score: mean (SD)* | 18.90 (±7.56) | 15.24 (±7.64) | 0.16 | 17.16 (±6.78) | 16.42 (±9.28) | 0.78 |
| CRQ dyspnoea score: median (IQR)† | 5.25 (4.40–6.00) | 5.80 (4.68–7.00) | 0.23 | 5.40 (5.00–6.20) | 6.00 (4.80–6.60) | 0.40 |
| CRQ fatigue score: mean (SD)* | 3.67 (±1.32) | 4.18 (±1.69) | 0.32 | 4.29 (±1.28) | 4.44 (±1.65) | 0.76 |
| CRQ emotional functioning score: mean (SD)* | 4.81 (±1.21) | 4.84 (±1.43) | 0.94 | 5.41 (±1.04) | 4.81 (±1.67) | 0.20 |
| CRQ mastery score: median (IQR)† | 5.00 (4.00–5.50) | 5.63 (4.81–6.75) | 0.06 | 5.50 (4.00–6.00) | 5.75 (4.50–6.75) | 0.43 |
| HADS anxiety score: mean (SD)* | 5.74 (±3.59) | 5.28 (±4.32) | 0.73 | 5.21 (±3.66) | 5.47 (±5.05) | 0.86 |
| HADS depression score: median (IQR)† | 5.00 (1.00–5.00) | 5.50 (2.00–7.00) | 0.59 | 4.00 (1.00–5.00) | 3.00 (1.00–8.00) | 0.99 |
| Blood eosinophil count (cells/µL): median (IQR)† | 200 (110–300) | 300 (200–300) | 0.31 | 200 (200–300) | 200 (190–370) | 0.40 |
| FeNO (ppb): median (IQR)† | 17.00 (8.50–26.00) | 14.00 (9.00–17.00) | 0.20 | 19.00 (13.00–35.50) | 13.00 (10.00–18.50) | 0.09 |
| Blood periostin concentration (ng/mL): median (IQR)† | 28.43 (6.30–60.00) | 35.85 (21.96–60.00) | 0.27 | 30.28 (27.03–60.00) | 34.02 (24.77–60.00) | 0.92 |
*t-test.
†Mann-Whitney U test.
AECOPD, acute moderate exacerbations of chronic obstructive pulmonary disease; CAT, Chronic Obstructive Pulmonary Disease Assessment Test; CRQ-SAS, Chronic Respiratory Disease Questionnaire Self-Administered Standardised Dyspnoea, Fatigue, Emotional functioning, Mastery scores; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity ; HADS, Hospital Anxiety and Depression Scale.