Asthma-related quality of life in active and placebo groups after 1 year of treatment
| Active | Placebo | Difference (95% CI)* | OR (95% CI)* | p Value* | |
| AQLQ responders ≥0.5† | |||||
| Intention to treat, n/N (%) | 143/189 (76%) | 56/92 (61%) | 14.8% (3% to 27%) | 1.92 (1.09 to 3.38) | 0.02 |
| Per protocol, n/N (%)‡ | 106/136 (77%) | 40/66 (61%) | 16.6% (3% to 30%) | 2.22 (1.11 to 4.40) | 0.02 |
| <12 years, n/N (%) | 37/46 (80%) | 14/22 (64%) | 16.8% (8% to 38%) | 5.57 (1.13 to 27.48) | 0.04 |
| ≥12 years, n/N (%) | 106/143 (74%) | 42/70 (60%) | 14.1% (1% to 28%) | 1.89 (0.98 to 3.65) | 0.06 |
| GINA 4 group, n/N (%)§ | 63/82 (77%) | 29/47 (62%) | 15.1% (2% to 31%) | 2.42 (1.05 to 5.60) | 0.04 |
| Poorly controlled, n/N (%)¶ | 93/125 (74%) | 30/58 (52%) | 22.7% (8% to 38%) | 3.45 (1.66 to 7.20) | <0.001 |
| GINA 4 poorly controlled, n/N (%)** | 43/57 (75%) | 15/30 (50%) | 25.4% (4% to 47%) | 4.74 (1.48 to 15.19) | 0.009 |
| AQLQ responders ≥1.0† | |||||
| Intention to treat, n/N (%) | 119/189 (63%) | 47/92 (51%) | 14.8% (3% to 26%) | 1.58 (0.93 to 2.69) | 0.09 |
| Per protocol, n/N (%)‡ | 89/136 (65%) | 33/66 (50%) | 15.4% (1% to 30%) | 1.85 (0.97 to 3.53) | 0.06 |
| <12 years, n/N (%) | 33/46 (72%) | 11/22 (50%) | 21.7% (−3% to 46%) | 4.40 (0.99 to 19.57) | 0.05 |
| ≥12 years, n/N (%) | 86/143 (60%) | 36/70 (51%) | 8.7% (−5% to 23%) | 1.37 (0.74 to 2.52) | 0.31 |
| GINA 4 group, n/N (%)§ | 51/82 (62%) | 24/47 (51%) | 15.1% (2% to 31%) | 1.96 (0.87 to 4.40) | 0.10 |
| Poorly controlled, n/N (%)¶ | 77/125 (62%) | 24/58 (41%) | 20.2% (5% to 35%) | 2.78 (1.36 to 5.67) | 0.005 |
| GINA 4 poorly controlled, n/N (%)** | 37/57 (65%) | 11/30 (37%) | 28.2% (7% to 49%) | 8.81 (2.14 to 36.32) | 0.003 |
| Change in AQLQ symptom domain | |||||
| Intention to treat | 1.32 (1.23) | 0.99 (1.38) | 0.31 (0.01 to 0.61) | 0.04 | |
| Per protocol‡ | 1.34 (1.14) | 0.96 (1.34) | 0.36 (0.01 to 0.71) | 0.04 | |
| <12 years | 1.46 (1.36) | 0.93 (1.49) | 0.38 (−0.34 to 1.10) | 0.29 | |
| ≥12 years | 1.27 (1.18) | 1.01 (1.36) | 0.28 (−0.62 to 0.05) | 0.10 | |
| GINA 4 group§ | 1.45 (1.14) | 1.00 (1.44) | 0.47 (0.03 to 0.91) | 0.04 | |
| Poorly controlled¶ | 1.41 (1.24) | 0.95 (1.60) | 0.58 (0.17 to 0.98) | 0.006 | |
| GINA 4 poorly controlled** | 1.45 (1.15) | 0.86 (1.70) | 0.70 (0.13 to 1.26) | 0.02 | |
↵* Adjusted analyses controlled for country, gender, years since asthma diagnosis, GINA treatment intensity step at baseline, and AQLQ value at baseline.
↵† Improvement was classified as ≥0.5 or ≥1.0 point increase in ‘AQLQ’ (=mini-AQLQ or PAQLQ) between installation of nocturnal TLA device and assessment 1 year later.
↵‡ Per protocol analyses excluded patients with consent withdrawn and/or with <80% treatment compliance (n=50 active; 27 placebo).
↵§ Asthma treatment intensity at baseline classified according to GINA 200612 where GINA step 4 is high treatment intensity.
↵¶ Poorly controlled asthma was defined as ACT score <18 at baseline.
↵** Poorly controlled asthma in combination with high treatment intensity.
ACT, Asthma Control Test; AQLQ, Asthma Quality of Life Questionnaire; GINA, Global Initiative for Asthma; PAQLQ, Paediatric Asthma Quality of Life Questionnaire.