[Fixed-dose fluticasone-salmeterol combination: at least effective and better tolerated than open-dose combinations]

Abstract

Background: Asthma guidelines recommend combining inhaled corticosteroids and long-acting inhaled B2-agonists when inhaled corticosteroids alone are insufficient to achieve good control of the disease.

Objectives: To determine in routine practice whether the fixed-dose fluticasone-salmeterol combination (FP/s) is as least as effective as inhaled corticosteroids combined with long-acting B2-agonists administered separately and to study patient perception.

Methodology: An open multicentric randomized study was conducted in two matched populations stratified by the prior treatment. Patients insufficiently controlled by moderate-dose inhaled corticosteroids +/- long-acting B2-agonists or high-dose inhaled corticosteroids alone were treated for 3 months using one inhalation of FP/S twice daily or inhaled corticosteroids and long-acting B2-agonists given separately (TC).

Results: Mean improvement in morning PEFR at 3 months was 39.2 +/- 4.1 l/min with FP/S and 30.7 +/- 4.0 l/min with TC. The difference (FP/S-TC: 8.5 l/min, CI95: -0.7 - 17.7 l/min) did not reach significance. There was no difference between the two groups for criteria other than TC. Tolerance was good in both groups.

Conclusion: The fixed-dose fluticasone-salmeterol combination is as least as effective as open combinations of inhaled corticosteroids and long-acting B2-agonists and is appreciated by patients (easier dosing, easier administration).