Fluticasone propionate hydrofluoroalkane inhalation aerosol in patients receiving inhaled corticosteroids.
BACKGROUND
Inhaled corticosteroids (ICSs) delivered by metered-dose inhalers that contain chlorofluorocarbon propellants are being discontinued because of the harmful effects of chlorofluorocarbon on the ozone layer. Therefore, some metered-dose inhaler products are being reformulated with "ozone-friendly" hydrofluoroalkane propellants.


OBJECTIVE
To evaluate treatment with fluticasone propionate hydrofluoroalkane inhalation aerosol, 88, 220, and 440 microg twice daily, vs placebo in patients with asthma receiving an ICS.


METHODS
Randomized, double-blind, parallel-group, 12-week study.


RESULTS
Mean morning predose percent predicted forced expiratory volume in 1 second increased by 2.2%, 3.2%, and 4.6% in the fluticasone propionate, 88-, 220-, and 440-microg twice-daily, groups, respectively, compared with an 8.3% decrease for placebo (P < .001 vs placebo for all groups). Secondary pulmonary function end points and asthma symptoms showed similar improvements compared with placebo. Discontinuation from the study due to lack of efficacy was 50% in the placebo group and 11%, 10%, and 6% in the fluticasone propionate, 88-, 220-, and 440-microg twice-daily, groups, respectively. At week 12, the probability of remaining in the study was 0.89, 0.90, and 0.94 for the fluticasone propionate, 88-, 220-, and 440-microg twice-daily, groups, respectively, vs 0.45 for the placebo group (P < .001 for all). Changes in 24-hour urinary cortisol excretion rates were similar among treatment groups.


CONCLUSIONS
Fluticasone propionate hydrofluoroalkane, previously shown to be a clinically suitable alternative to fluticasone propionate chlorofluorocarbon, was effective and well tolerated. The ability to switch from fluticasone propionate chlorofluorocarbon and other chlorofluorocarbon-containing ICSs to fluticasone propionate hydrofluoroalkane without sacrificing asthma control or tolerability will facilitate a smooth transition to this nonchlorofluorocarbon-containing medicinal.
Lumry
William R
WR
AARA Research Center, Dallas, TX 75231, USA. lumrymd@sbcglobal.net
Conway
Michael M
MM
LaForce
Craig F
CF
Pearlman
David S
DS
Scott
Catherine A
CA
Herje
Nancy E
NE
Wu
Wei W
WW
Crim
Courtney
C
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000335:Aerosol Propellants / Q000008:administration & dosage / Q000009:adverse effects; D000368:Aged; D000369:Aged, 80 and over; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D001249:Asthma / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology / Q000652:urine; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D002648:Child; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D006845:Hydrocarbons, Fluorinated / Q000008:administration & dosage* / Q000009:adverse effects; D006854:Hydrocortisone / Q000652:urine; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D010366:Peak Expiratory Flow Rate / Q000187:drug effects; D005466:Fluorocarbons
D000335:Aerosol Propellants; D000730:Androstadienes; D001993:Bronchodilator Agents; D000068298:Fluticasone; D006845:Hydrocarbons, Fluorinated; D006854:Hydrocortisone; C094049:apaflurane; D005466:Fluorocarbons