Primary and secondary outcome measures: comparison between groups
| Outcome measure | Baseline | Difference at week 12**end stable ICS dose(95% CI) | Difference at week 28**end ICS reduction(95% CI) | Comparison between groups(p value) | ||||
|---|---|---|---|---|---|---|---|---|
| Group A | Group B | Base | Week 12 | Week 28 | ||||
| *Mean (SD). | ||||||||
| †Median (IQR). | ||||||||
| ‡Geometric mean (SD). | ||||||||
| ¶Asthma Quality of Life Questionnaire; range (best–worst) 0–4. | ||||||||
| §Complete Asthma Control Questionnaire questions 1–7; range (best–worst) 0–6. | ||||||||
| **Differences represent Group A − Group B; ratios represent Group A/Group B. | ||||||||
| ††Measured at clinic visit. | ||||||||
| ‡‡Measured on a visual analogue scale from 0 (worst) to 100 (best). | ||||||||
| §§Measured on a custom built device (see online supplement). | ||||||||
| ¶¶Recorded using electronic diary spirometers. | ||||||||
| ***Calculated based on data recorded on electronic diary spirometers. | ||||||||
| AQLQ – total* ¶ | 0.77 (0.50) | 0.54 (0.30) | 0.14 (−0.13 to 0.41) [Missing: A:3, B:2] | 0.14 (−0.11 to 0.38) | 0.04 | 0.29 | 0.27 | |
| Day symptom intensity score† ¶¶ | 2.00 (2.00) | 2.00 (2.00) | 0.45 (0.09 to 0.81)[Missing: A:2, B:2] | 0.27 (−0.21 to 0.75) [Missing: B:3] | 0.73 | 0.02 | 0.26 | |
| Night symptom intensity score† ¶¶ | 2.00 (1.00) | 2.00 (1.00) | 0.34 (−0.02 to 0.70) [Missing: A:2, B:3] | 0.27 (−0.14 to 0.68) [Missing: B:4] | 0.53 | 0.06 | 0.20 | |
| Symptom free days (%)* *** | 23.51 (26.83) | 22.07 (30.45) | −4.25 (−14.45 to 5.96) [Missing: A:2, B:2] | −8.56 (−22.74 to 5.61) [Missing: B:3] | 0.85 | 0.81 | 0.23 | |
| Reliever use (puffs/day)* ¶¶ | 2.94 (2.20) | 3.09 (2.28) | 0.51 (−0.22 to 1.23) [Missing: A:2, B:2] | 0.005 (−0.98 to 0.99) [Missing: B:3] | 0.81 | 0.17 | 0.99 | |
| Reliever free days (%)† *** | 6.67 (42.42) | 8.33 (41.67) | −4.85 (−23.90 to 14.21) [Missing: A:2, B:2] | 1.89 (−18.49 to 22.27) [Missing: B:3] | 0.49 | 0.19 | 0.63 | |
| ACQ-7§* | 1.46 (0.61) | 1.37 (0.55) | 0.21 (−0.14 to 0.56) [Missing: A:1] | 0.11 (−0.20 to 0.43) | 0.57 | 0.23 | 0.47 | |
| Patient Global Assessment* ‡‡ | 61.32 (24.89) | 66.17 (20.76) | −6.21 (−18.66 to 6.23) [Missing: B:1] | −4.84 (−17.49 to 7.82) | 0.43 | 0.32 | 0.45 | |
| Physician Global Assessment‡‡ | 61.43 (15.14) | 62.31 (15.89) | −1.15 (−10.25 to 7.95) | −2.37 (−10.33 to 5.60) | 0.83 | 0.80 | 0.55 | |
| Lung function (FEV1% predicted)* †† | 80.78 (16.14) | 78.93 (16.96) | 1.94 (−1.77 to 5.64) | −2.27 (−6.02 to 1.49) | 0.68 | 0.30 | 0.23 | |
| Lung function (FVC% predicted)* †† | 103.09 (19.22) | 101.55 (18.01) | 2.41 (−3.09 to 7.91) | −0.18 (−5.51 to 5.16) | 0.76 | 0.38 | 0.95 | |
| End tidal CO2 (%)† §§ | 4.14 (1.90) | 3.77 (1.17) | −0.20 (−1.03 to 0.24) [Missing: A:3, B:5] | 0.28 (−0.22 to 0.91) [Missing: A:1, B:3] | 0.71 | 0.37 | 0.26 | |
| Route of breathing (nasal/%) | 16/20 (80%) | 13/23 (57%) | A: 14/19 (73.68%)B: 14/21 (66.67%) | A: 14/14 (100%)B: 7/17(41.18%) | 0.1936 | 0.3970 | 0.0023 | |
| Ratios at week 12**(95% CI of ratio) | Ratios at week 28**(95% CI of ratio) | Comparison between groups(p value) | ||||||
| RDR mannitol (% fall/mg)‡ | 0.02 (30.16) | 0.18 (1.19) | 1.17 (0.69 to 1.99) [Missing: A:12, B:16] | 0.79 (0.50 to 1.25)[Missing: A:10, B:12] | 0.28 | 0.54 | 0.30 | |