IngentaConnect Salmeterol/Fluticasone Combination Inhaler: A New, Effective and ...

Abstract:

Objective: The efficacy and tolerability of a new combination inhaler containing both salmeterol 50mg and fluticasone 100mg 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 (50/100mg twice daily) via a single inhaler (combination) and placebo twice daily via another, or salmeterol 50mg twice daily via one inhaler and fluticasone 100mg 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 (FEV) 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.

Keywords: Salmeterol.fluticasone-propionate, therapeutic-use; Asthma, treatment; Randomised-controlled-trials; Salmeterol, therapeutic-use; Fluticasone-propionate, therapeutic-use; Inhaled-preparations; Antiasthmatics, therapeutic-use

Language: English

Document Type: Original article

Affiliations: 1: University of Cape Town and Groote Schuur Hospital, Cape Town, South Africa 2: St Peters Hospital, Chertsey, Surrey, England 3: Seccion de Algergia, Hospital Universtario, Las Palmas, de Gran Canaria, Spain 4: Hospital de Sao Joao, Servico de Pneumalogia, Porto, Portugal 5: Respiratory Clinical Research, GlaxoWellcome Research and Development, Greenford, Middlesex, England *

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Salmeterol/Fluticasone Combination Inhaler: A New, Effective and Well Tolerated Treatment for Asthma