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(1)) 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.
RCT Entities:
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 asthmapatients (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(1)) 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.
Authors: T Haahtela; M Järvinen; T Kava; K Kiviranta; S Koskinen; K Lehtonen; K Nikander; T Persson; K Reinikainen; O Selroos Journal: N Engl J Med Date: 1991-08-08 Impact factor: 91.245
Authors: R A Pauwels; C G Löfdahl; D S Postma; A E Tattersfield; P O'Byrne; P J Barnes; A Ullman Journal: N Engl J Med Date: 1997-11-13 Impact factor: 91.245
Authors: S L Spector; R Kinsman; H Mawhinney; S C Siegel; G S Rachelefsky; R M Katz; A S Rohr Journal: J Allergy Clin Immunol Date: 1986-01 Impact factor: 10.793
Authors: P Chervinsky; A van As; E A Bronsky; R Dockhorn; M Noonan; C LaForce; W Pleskow Journal: J Allergy Clin Immunol Date: 1994-10 Impact factor: 10.793
Authors: M Noonan; P Chervinsky; W W Busse; S C Weisberg; J Pinnas; B P de Boisblanc; H Boltansky; D Pearlman; L Repsher; D Kellerman Journal: Am J Respir Crit Care Med Date: 1995-11 Impact factor: 21.405