Each actuation of Combisal (salmeterol/fluticasone) provides 25 micrograms of salmeterol with 50, 125 or 250 micrograms of fluticasone propionate. Combisal is indicated for the regular treatment of asthma where use of a combination product (long-acting β2-agonist and inhaled corticosteroid) is appropriate, in patients:
- not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting β2-agonist, or
- already adequately controlled on both inhaled corticosteroid and long-acting β2-agonist.
As with Seretide Evohaler, the lower-strength 25 microgram/50 microgram Combisal inhaler is suitable for prescribing in children aged 4 years and over. The two higher strengths can be prescribed for children aged 12 years and over, allowing treatment of under 18s requiring higher doses of steroid.
The existing salmeterol/fluticasone MDIs AirFluSal, Aloflute, Sereflo and Sirdupla are available in 25 microgram/125 microgram and 25 microgram/250 microgram strengths and are licensed for use from 18 years.
Bioequivalence of Combisal with Seretide Evohaler has been demonstrated for the higher-strength 25 microgram/250 microgram product in double-blind crossover studies involving healthy adult males using the Aerochamber Plus spacer or without a spacer. A biowaiver has been claimed for the lower strength products, which is supported by in vitro data.
The incidence of common adverse effects with Combisal was similar to that observed with other salmeterol/fluticasone inhalers, the most commonly reported being headache and nasopharyngitis.