Efficacy and safety of fluticasone propionate/salmeterol HFA 134A MDI in patients with mild-to-moderate persistent asthma.
The objective of this study was to compare the efficacy and safety of fluticasone propionate (FP) (44 microg)/salmeterol (21 microg) delivered as two inhalations twice daily via a single hydrofluoroalkane (HFA 134a) metered dose inhaler (MDI) (FSC) with that of placebo HFA 134a (PLA), fluticasone propionate 44 microg chlorofluorocarbon (CFC) alone and salmeterol 21 microg CFC alone (S) in patients (n=360) with persistent asthma previously treated with beta2-agonists (short- or long-acting) or inhaled corticosteroids (ICS). After 12 weeks of treatment, patients treated with FSC had a significantly greater increase (p < or = 0.006) in mean FEV1 AUC(bl) compared with PLA, FP, or S. At end point, mean change from baseline in morning predose FEV1 for FSC (0.58 L) was significantly (p < or = 0.004) greater than PLA (0.14 L), FP (0.36 L), and S (0.25 L). Patients treated with FSC also had a significantly higher probability of remaining in the study without being withdrawn due to worsening asthma (2%) compared with those in the PLA (29%) and S (25%) groups (p < 0.001). Finally, treatment with FSC resulted in significantly (p < or = 0.007) greater improvements in morning and evening peak expiratory flow, need for rescue albuterol, and asthma symptom scores compared with FP, S, and PLA. The safety profile of FSC was also similar to FP or S alone. Initial maintenance treatment of the two main components of asthma, inflammation, and smooth muscle dysfunction (e.g., bronchoconstriction), with FSC results in greater overall improvements in asthma control compared with treatment of either individual component alone.
Pearlman
David S
DS
Colorado Allergy and Asthma Centers, P.C., Denver, Colorado 80230, USA. ds.pearlman@coloradoallergy.com
Peden
David
D
Condemi
John J
JJ
Weinstein
Steven
S
White
Martha
M
Baitinger
Leslie
L
Scott
Catherine
C
Ho
Shu-Yen
SY
House
Karen
K
Dorinsky
Paul
P
D000293:Adolescent; D000328:Adult; D000335:Aerosol Propellants; D000368:Aged; D000369:Aged, 80 and over; D000420:Albuterol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D000730:Androstadienes / Q000009:adverse effects / Q000627:therapeutic use*; D000893:Anti-Inflammatory Agents / Q000009:adverse effects / Q000627:therapeutic use*; D019540:Area Under Curve; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D017402:Chlorofluorocarbons; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination; D006801:Humans; D006845:Hydrocarbons, Fluorinated; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D012129:Respiratory Function Tests; D005466:Fluorocarbons
D000335:Aerosol Propellants; D000420:Albuterol; D000730:Androstadienes; D000893:Anti-Inflammatory Agents; D017402:Chlorofluorocarbons; D004338:Drug Combinations; D000068297:Fluticasone-Salmeterol Drug Combination; D006845:Hydrocarbons, Fluorinated; C094049:apaflurane; D005466:Fluorocarbons