SALMETEROL FLUTICASONE COMBINATION INHALER - A NEW, EFFECTIVE AND WELL TOLERATED TREATMENT FOR ASTHMA/

Citation
Ed. Bateman et al., SALMETEROL FLUTICASONE COMBINATION INHALER - A NEW, EFFECTIVE AND WELL TOLERATED TREATMENT FOR ASTHMA/, Clinical drug investigation, 16(3), 1998, pp. 193-201
Citations number
20
Categorie Soggetti
Pharmacology & Pharmacy
Journal title
ISSN journal
11732563
Volume
16
Issue
3
Year of publication
1998
Pages
193 - 201
Database
ISI
SICI code
1173-2563(1998)16:3<193:SFCI-A>2.0.ZU;2-0
Abstract
Objective: The efficacy and tolerability of a new combination inhaler containing both salmeterol 50 mu g and fluticasone 100 mu g in a singl e device was compared with the delivery of the two drugs via two separ ate inhalers in a multicentre, double-blind, double-dummy study. Patie nts: 244 symptomatic asthma patients (age range 12 to 78 years) were r andomised to a 12-week treatment period with either salmeterol/flutica sone (50/100 mu g twice daily) via a single inhaler (combination) and placebo twice daily via another, or salmeterol 50 mu g twice daily via one inhaler and fluticasone 100 mu g twice daily via another (concurr ent). 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 pe riod. Adjusted mean improvements in forced expiratory volume in 1 seco nd (FEV1) from baseline at week 12 were 0.20 and 0.17L for combination and concurrent therapies, respectively. 60% of patients receiving com bination inhaler and 64% of those receiving concurrent therapy had a m ean daytime symptom score of zero over the treatment period compared w ith 17 and 15%, respectively, at baseline. Both treatments were well t olerated. Geometric mean morning serum cortisol levels were similar an d no differences in the frequency of abnormal results were noted betwe en the two groups. Conclusion: This was the first study reporting the control of asthma by administration of salmeterol and fluticasone in c ombination via a single inhaler. The new combination inhaler was as ef fective and well tolerated as the two drugs administered individually and has potential advantages in terms of convenience.