Comparison of hydrofluoroalkane-beclomethasone dipropionate Autohaler with budesonide Turbuhaler in asthma control.
BACKGROUND
Hydrofluoroalkane-beclomethasone dipropionate Autohaler (HFA-BDP AH) is a breath-actuated chlorofluorocarbon (CFC)-free metered dose inhaler in which BDP is in a solution of HFA propellant. Budesonide Turbuhaler (BUD TH) is a breath-dependent dry powder inhaler.


OBJECTIVE
To test the hypothesis that half the daily dose of HFA-BDP AH would provide an equivalent control of asthma symptoms to the BUD TH.


METHODS
This was an 8-week open study in patients with symptomatic moderate-to-severe asthma, previously on BUD 500-1,000 microg x day(-1), or an equivalent. After 5-14 days' run-in, patients were randomized to HFA-BDP AH 800 microg x day(-1) or BUD TH 1,600 microg x day(-1). The intent-to-treat population consisted of 111 patients on HFA-BDP AH and 98 patients on BUD TH.


RESULTS
Mean change from baseline in PEF in the morning (AM PEF) at week 8 was 23.95 liters x min(-1) for HFA-BDP AH and 24.46 liters x min(-1) for BUD TH. A two-sided equivalence test using the 0.51 liter x min(-1) difference gave 95% confidence intervals within a defined equivalence interval of (-infinity, 25 liters x min(-1)) indicating that the mean change in AM PEF was equivalent for the two groups. There were no significant differences in the mean change from baseline in FEV1 or beta-agonist use. Patients using HFA-BDP AH had a significantly greater mean change from baseline in the percentage of days free from shortness of breath (p = 0.05), chest tightness (p = 0.02) and nights without sleep disturbance (p = 0.04) at week 3, and wheeze (p = 0.01), shortness of breath (p = 0.02), chest tightness (p < 0.01) and daily asthma symptoms (p = 0.03) at week 8. The incidence, type and severity of adverse events were similar in each group. At week 8, the mean change from baseline in corrected urine cortisol/creatinine ratio in a subgroup of patients was -0.36 for HFA-BDP and -4.88 for BUD TH (p < 0.01).


CONCLUSIONS
HFA-BDP 800 microg x day(-1) provided control of moderate-to-severe asthma with efficacy and safety at least similar to BUD TH 1,600 microg x day(-1).
Worth
H
H
Medizinische Klinik I, Klinikum Fürth, Germany.
Muir
J F
JF
Pieters
W R
WR
D000280:Administration, Inhalation; D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D001249:Asthma / Q000097:blood / Q000188:drug therapy* / Q000517:prevention & control*; D001507:Beclomethasone / Q000627:therapeutic use*; D001798:Blood Proteins / Q000187:drug effects; D019819:Budesonide / Q000627:therapeutic use*; D015331:Cohort Studies; D003404:Creatinine / Q000652:urine; D047091:Eosinophil Granule Proteins; D004804:Eosinophils / Q000187:drug effects; D005260:Female; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume / Q000187:drug effects; D005602:France / Q000453:epidemiology; D005858:Germany / Q000453:epidemiology; D006801:Humans; D006845:Hydrocarbons, Fluorinated / Q000627:therapeutic use*; D006854:Hydrocortisone / Q000652:urine; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D010366:Peak Expiratory Flow Rate / Q000187:drug effects; D012129:Respiratory Function Tests; D012260:Ribonucleases; D016896:Treatment Outcome; D005466:Fluorocarbons
D000893:Anti-Inflammatory Agents; D001507:Beclomethasone; D001798:Blood Proteins; D019819:Budesonide; D003404:Creatinine; D047091:Eosinophil Granule Proteins; D006845:Hydrocarbons, Fluorinated; D006854:Hydrocortisone; D012260:Ribonucleases; C094049:apaflurane; D005466:Fluorocarbons