492 The addition of salmeterol to fluticasone versus increased-dose fluticasone: An analysis of asthma exacerbations

Abstracts

J ALLERGY CLIN IMMUNOL VOLUME 105, NUMBER 1, PART 2

492

493

The Addition of Salmeterol to Fluticasone Versus IncreasedDose Fluticasone: An Analysis of Asthma Exacerbations Christopher Kalberg, Amanda Emmett. Sreven Yancq K Rickord Glaxo Wellcome, Inc The rates and characteristics of asthma exacerbations with the combined use of salmeterol and low-dose fluticasone (FP) was compared to increased-dose FP. An analysis of 104 asthma exacerbations was conducted using data from two multicenter. randomized, doubleblind, 6-month studies that compared the addition of salmeterol (42 mcg BID) to low-dose fluticasone propionate (FP88, 88 mcg BID) versus increasing the dose of fluticasone to 220mcg BID (FP220) in patients with persistent asthma. All asthma exacerbations analyzed required the use of oral or parenterol corticosteroids and changes in AM PEE rescue albuterol use, and symptom scores that occurred before and after asthma exacerbations were evaluated. A total 18 (7%)patients with mild to moderate airway obstruction (baseline FEV, values >60-85% predicted) experienced exacerbations with salmeterol+FP88 as compared to 27 (11%) patients with FP22. With severe obstruction (FEV, = 40-60% predicted), 23 (11%) and 36 (17%) of patients experienced exacerbations in the salmterol+FP88 and FP220 groups, respectively. Changes in AM PEF over the 14 days before and after exacerbation were similar in both groups and increases in rescue albuterol use and symptom scores tended to be greater in the FP220 group. This analysis indicates that the combined use of salmeterol and low-dose FP results in fewer exacerbations than increased-dose FP and that the severity and duration of exacerbations are similar with both treatments. Advairm /SeretideTM (Salmeterol SOmcglFluticasone Propionate 250 mcg bid) Compared With Budesonide (800 mcg bid) During the First Week of Treatment of Moderate Asthma Christine Jenkins*. Anne Woolcock*, P Saarelainenf, Mark James* *Royal Prince Alfred Hospital, Sydney, Australia tLaakso Hospital, Helsinki, Finland SGlaxo Wellcome R&D Ltd. United Kingdom Additional treatment with long-acting P2-agonists to inhaled corticosteroids in moderate asthma is considerably more effective than increasing steroid doses in moderate asthmatics. A metered-dose dry powder DiskusTM inhaler containing both salmeterol5O(g and fluticasone propionate 250mcg per puff (AdvairTM/SeretideTM 50/250) has therefore been developed for the convenient treatment of such patients. AdvairTMISeretide TM (50/250) bid was compared with budesonide 8OOmcg bid in 353 symptomatic moderate asthmatics who had been previously treated with 800 to 1200mcg inhaled steroids daily in this double blind, randomized, 24-week study. Results showing mean morning PEE percentage of days with no asthma symptoms and percentage of days with no requirement for rescue salbutamol usage for days I to 7 are shown below.

MEAN

AM PEF

(WIN)

ADVAIR~ / SERETID~ lN=180)

BUDESONIOE (N=173)

BASELINE DAY

365

356

DAY I DAY 2 DAY 7

387 396 398

361 363 369

MEAN W PATIENTS WITH NO SYMPTOMS BASELINE

%PATlENTS NONEED FOR PRN

DAY

S161

P
14

10

DAY 1 DAY 2 DAY I

32 37 38

21 24 2-I

BASELINE DAY DAY I DAY 2 DAY 7

15 38 43

29 29

P-CO.05

45

30

Pco.01

Pco.05 P
WITH

SALBUTAMOL

11 NS

These improvements from the first and second days of treatment remained significantly greater in the AdvairYSeretideTM group than the budesonide group throughout the 24-week study period. Overall, the mean difference in morning PEF was 25L/min higher in the AdvairTM/SeretideTM group (p