TABLE I.
Quality of life scores from 3 American Lung Association ACRC trials (means ± SEs)
| TAPE |
LOCCS2 |
LODO3 |
||||||
|---|---|---|---|---|---|---|---|---|
| Montelukast | Placebo | Montelukast | Fluticasone | Fluticasone-salmeterol | Montelukast | Placebo | Theophylline | |
| Juniper Mini Asthma Quality of Life | ||||||||
| N, adults§ | 235 | 233 | 130 | 126 | 124 | 139 | 138 | 131 |
| Baseline emotional dimension (↑, 1-7) | 5.1 ± 0.1 | 5.2 ± 0.1 | 5.8 ± 0.1 | 5.7 ± 0.1 | 6.0 ± 0.1 | 4.0 ± 0.1 | 4.1 ± 0.1 | 4.1 ± 0.1 |
| Change at 2 wk | 0.7 ± 0.1 | 0.4 ± 0.1* | — | — | — | — | — | |
| Change at 4 wk | 0.6 ± 0.1 | 0.5 ± 0.1 | 0.0 ± 0.1 | 0.0 ± 0.1 | 0.0 ± 0.1 | |||
| Change at 16 wk‡ | –0.1 ± 0.1 | 0.0 ± 0.1 | –0.1 ± 0.1 | |||||
| Change at 24 wk | — | 1.0 ± 0.1 | 0.8 ± 0.1 | 0.6 ± 0.1 | ||||
| N, children (ages 6 to 14 y) | 32 | 35 | 29 | |||||
| Baseline emotional dimension (↑, 1-7)§ | 6.3 ± 0.1 | 6.7 ± 0.1 | 6.5 ± 0.1 | — | — | — | ||
| Change at 4 wk | — | 0.0 ± 0.1 | 0.0 ± 0.1 | 0.3 ± 0.1† | ||||
| Change at 16 wk‡ | 0.4 ± 0.1 | 0.2 ± 0.1 | 0.2 ± 0.1 | |||||
| Short Form-36 mental score | ||||||||
| N§ | 234 | 233 | ||||||
| Baseline mental score (↑, 0-100) | 49.1 ± 0.7 | 50.8 ± 0.6 | ||||||
| Change at 2 wk | 1.8 ± 0.5 | –0.2 ± 0.5* | — | — | — | — | — | — |
| Change at 4 wk | 2.1 ± 0.6 | 0.8 ± 0.5 | ||||||
↑ Increase indicates an improvement; —, data not collected.
*
P value for treatment difference is ≤.01.
†
P value ≤.10.
‡
N = 367 and N = 95 for adults and children at 16 wk, respectively.
§
Number of patients with follow-up data on well-being measures.