TABLE 3.
6 months before randomisation
|
6 months after randomisation
|
Difference¶ | |||||
---|---|---|---|---|---|---|---|
All participants | Intervention | Control | All participants | Intervention | Control | ||
Subjects n | 90 | 46 | 44 | 90 | 46 | 44 | 18 (−5, 40) |
Use of long-term controllers | 79 | 74 | 84 | 77 | 80 | 73 | 18 (−5, 40) |
Type of long-term controllers | |||||||
ICS alone | 27 | 24 | 29 | 25 | 22 | 27 | 0 (−17, 17) |
ICS+LABA only | 31 | 33 | 29 | 30 | 35 | 25 | 7 (−12, 25) |
LTRA alone | 7 | 6 | 7 | 9 | 8 | 9 | 0 (−9, 9) |
ICS+LTRA | 2 | 0 | 5 | 3 | 2 | 5 | 2 (−6, 10) |
ICS+LABA+LTRA | 12 | 11 | 14 | 10 | 13 | 7 | 9 (−5, 23) |
Beclomethasone canister equivalents+ | 8.3±8.9 | 7.7±8.9 | 9.0±9.1 | 7.9±9.0 | 8.8±9.9 | 7.1±8.1 | 3.0 (−0.4, 6.3) |
SABA user | 72 | 76 | 68 | 62 | 59 | 66 | −15 (−36, 6) |
Albuterol canister equivalents§ | 1.9±2.2 | 1.7±2.1 | 2.1±2.3 | 1.7±1.9 | 1.4±1.7 | 1.9±2.1 | −0.1 (−0.8, 0.5) |
Participants with asthma exacerbations requiring systemic corticosteroidsf | 20 | 22 | 18 | 13 | 11 | 16 | −9 (−28, 11) |
Total days of systemic corticosteroid supply for asthma exacerbationsf | 9.4±6.1 | 8.6±3.7 | 10.5±8.5 | 11.3±5.6 | 11.4±5.2 | 11.1±6.3 | −1.6 (−16.2, 13.0) |
Asthma-related healthcare encounters## | |||||||
Hospitalisation | 1 | 2 | 0 | 2 | 2 | 2 | −2 (−10, 5) |
Emergency department visit | 11 | 9 | 14 | 9 | 7 | 11 | 0 (−18, 18) |
Outpatient visit | 49 | 46 | 52 | 38 | 43 | 32 | 18 (−9, 46) |
Data are presented as mean±SD or %, unless otherwise stated. ICS: inhaled corticosteroid; LABA: long-acting, inhaled β2-agonist; LTRA: leukotriene modifier; SABA: short-acting β-agonist.
extracted healthcare utilisation data from electronic health records included all visits by service type (emergency department, hospital inpatient or outpatient department) to Kaiser Permanente in Northern California and its contracted facilities, and pharmacy dispensing records;
covariate-adjusted, mixed-model-based mean (95% CI) for between-treatment differences in change from 6 months before to 6 months after randomisation;
estimated total number of canisters of beclomethasone to which an asthma controller medication dispensed for a patient in each 6-month period was equivalent in terms of its anti-inflammatory effectiveness (each dispensing of a controller medication (excluding theophylline and systemic corticosteroids used for >15 days), in any form or quantity, was assigned a weight representing its equivalent in fractional or multiple canisters of beclomethasone 80 mg [27]; weighted values were summed for each patient to obtain a cumulative measure of controller medication dose dispensed during the 6 months before and after randomisation separately);
estimated total number of canisters of albuterol to which the amount of SABA dispensed in each 6-month period was equivalent in terms of its bronchodilator effectiveness (each SABA medication, in any type or delivery mode, was assigned a weight representing its equivalent in canister of albuterol [27]; weighted values were summed for each patient to obtain a cumulative measure of dose dispensed during the 6 months before and after randomisation separately);
defined as systemic corticosteroids (by tablet, suspension or injection) dispensed for 3–15 days of use;
asthma-related healthcare encounters were visits with International Classification of Diseases, ninth revision (Clinical Modification) code 493 as a primary or secondary diagnosis.