Abstract
Objective: The efficacy and tolerability of a new combination inhaler containing both salmeterol 50μg and fluticasone 100μg in a single device was compared with the delivery of the two drugs via two separate inhalers in a multicentre, double-blind, double-dummy study.
Patients: 244 symptomatic asthma patients (age range 12 to 78 years) were randomised to a 12-week treatment period with either salmeterol/fluticasone (50/100μg twice daily) via a single inhaler (combination) and placebo twice daily via another, or salmeterol 50μg twice daily via one inhaler and fluticasone 100μg twice daily via another (concurrent).
Results: Morning peak expiratory flow rate (PEFR), symptoms and tolerability were collected throughout the treatment period. Adjusted mean improvements in morning PEFR were 42 and 33 L/min for combination and concurrent therapies, respectively, over the 12-week treatment period. Adjusted mean improvements in forced expiratory volume in 1 second (FEV1) from baseline at week 12 were 0.20 and 0.17L for combination and concurrent therapies, respectively. 60% of patients receiving combination inhaler and 64% of those receiving concurrent therapy had a mean daytime symptom score of zero over the treatment period compared with 17 and 15%, respectively, at baseline. Both treatments were well tolerated. Geometric mean morning serum cortisol levels were similar and no differences in the frequency of abnormal results were noted between the two groups.
Conclusion: This was the first study reporting the control of asthma by administration of salmeterol and fluticasone in combination via a single inhaler. The new combination inhaler was as effective and well tolerated as the two drugs administered individually and has potential advantages in terms of convenience.
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Bateman, E.D., Britton, M., Carrillo, J. et al. Salmeterol/Fluticasone Combination Inhaler. Clin. Drug Investig. 16, 193–201 (1998). https://doi.org/10.2165/00044011-199816030-00003
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DOI: https://doi.org/10.2165/00044011-199816030-00003