Effects on Small Airways Obstruction of Two Long-term Treatments With Extrafine Beclomethasone/Formoterol vs Fluticasone/Salmeterol in Asthma

Study design After a 4-week washout period, during which patients were allowed to take only salbutamol (as needed), they were assigned according to a double-blind, double-dummy randomized crossover study to one of the two following 24-week treatments: 1) formoterol 12 µg plus beclomethasone HFA 200 µg (by MDI) b.i.d., or 2) salmeterol 50 µg plus fluticasone propionate 250 µg (diskus) b.i.d.. Daily doses of 400 µg beclomethasone HFA and 500 µg of fluticasone propionate are equivalent, according to the Global Initiative for Asthma (GINA) International guidelines6. At the end of first period and after another 4-week washout period, they received the second randomized 24-week treatment.

Adherence to the treatment was based on self-reports by each patient, on a declaration of willingness to continue to participate to the study and on the counter of drug doses disposed by inhalers. All patients have been trained to correctly inhale the drugs by different devices.

At the end of the washout periods and two treatments the subjects underwent Asthma Control Test (ACT), oxygen saturation (SaO2) measurement and Pulmonary Function Testing (PFT).

The subjects were enrolled after obtainment of written consent. The protocol has been approved by our local Ethic Committee.

Asthma Control Test Subjects completed an ACT questionnaire at the end of each washout and treatment period. Asthma control was assessed by the validated Italian version of the ACT. They subjectively evaluated the degree of impairment caused by their asthma during the preceding 4 weeks answering to five questions using a five-point-scale. The ACT is a reliable and validated tool, responsive to changes in asthma control over time. A cut-off score of 19 or less identifies subjects with poorly controlled asthma.