AirFluSal Forspiro contains 50 microgram salmeterol and 500 microgram fluticasone propionate, making its active ingredients and pre-dispensed dose identical to Seretide 500 Accuhaler. One inhalation is taken twice daily.
The inhaler is indicated for use in patients from 18 years of age with a history of repeated exacerbations and significant symptoms despite regular bronchodilator therapy.
AirFluSal Forspiro contains 60 doses of medication in pre-dispensed blisters on a coiled strip of foil. A lever is lifted to move a new blister into position, and then pressed to pierce the blister. Used blisters can then be torn off. The dose counter counts down from 60 to 0 with the last 10 doses appearing on a red background.
The equivalence study used to support approval of AirFluSal Forspiro was conducted outside the licensed COPD indication, in 555 patients with asthma. Results showed there was no significant difference in FEV1 increases over 12 weeks between patients using AirFluSal Forspiro and those using Seretide 500 Accuhaler. Asthma symptom scores improved to a similar extent in the two groups and the proportion of patients with controlled asthma was comparable between groups.
Safety profiles were similar for the two devices.
Updated 11th March 2016
Previous versions of this article included the statement "Equivalence to Seretide Accuhaler was shown in patients with asthma". This sentence has been revised to emphasise that the inclusion of asthma patients in the equivalence study was outside the licensed indication of AirFluSal Forspiro in COPD. AirFluSal Forspiro is not indicated for use in asthma.