A comparison of budesonide/formoterol maintenance and reliever therapy vs. conventional best practice in asthma management.
OBJECTIVE
To study the effectiveness and safety of budesonide/formoterol (Symbicort) Maintenance And Reliever Therapy (Symbicort SMART, AstraZeneca, Södertalje, Sweden), a simplified management approach with one inhaler compared with conventional best practice (CBP) with multiple inhalers in patients with persistent asthma.


METHODS
Open-label randomised controlled parallel group trial, 6-month treatment.


METHODS
A total of 908 patients > or = 12 years of age, with persistent asthma receiving treatment with inhaled corticosteroids (ICS), either alone or in conjunction with long-acting beta(2)-agonist.


METHODS
Time to first severe asthma exacerbation and number of severe asthma exacerbations.


RESULTS
No difference between groups was seen in time to first severe exacerbation (p = 0.75). Exacerbation rates were low in both groups. A total of 12 patients in the Symbicort SMART group experienced a total of 14 severe asthma exacerbations, and 19 patients in the CBP group experienced a total of 25 severe asthma exacerbations (annual rate 0.07 vs. 0.13 p = 0.09). The mean daily dose of ICS expressed in BDP equivalent was significantly lower in the Symbicort SMART group (including as-needed use) vs. in the CBP group (749 microg vs. 1059 microg; p < 0.0001). Mean scores in Asthma Control Questionnaire, 5 question version improved significantly in the SMART group compared with the CBP group (p = 0.0026). Symbicort SMART and CBP were equally well tolerated. The mean drug cost/patient/month was significantly lower for the patients in the Symbicort SMART group compared with patients receiving CBP (51.3 euros vs. 66.5 euros; p < 0.0001).


CONCLUSIONS
In Belgian patients, a simplified regimen using budesonide/formoterol maintenance and reliever therapy was at least as effective at improving clinical control compared with CBP with a significantly lower ICS dose and significantly lower drug costs.
Louis
R
R
Pneumology, CHU Sart Tilman, Liège, Belgium. r.louis@chu.ulg.ac.be
Joos
G
G
Michils
A
A
Vandenhoven
G
G
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000191:economics; D001249:Asthma / Q000188:drug therapy* / Q000191:economics; D019819:Budesonide / Q000008:administration & dosage* / Q000191:economics; D002648:Child; D016527:Drug Costs; D004983:Ethanolamines / Q000008:administration & dosage* / Q000191:economics; D005260:Female; D005541:Forced Expiratory Volume / Q000502:physiology; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D017060:Patient Satisfaction; D010366:Peak Expiratory Flow Rate / Q000502:physiology; D012008:Recurrence; D016896:Treatment Outcome; D055815:Young Adult
D018927:Anti-Asthmatic Agents; D004983:Ethanolamines; D019819:Budesonide; D000068759:Formoterol Fumarate