Comparison of efficacy and safety between flunisolide/AeroChamber and budesonide/turbuhaler in patients with moderate asthma. AER-MD-04 Study Group.
BACKGROUND
There is a limited body of evidence comparing the clinical effects of different inhaled corticosteroids in the treatment of asthma. This study compared the safety and efficacy of inhaled flunisolide and budesonide, both with unique delivery systems that may affect clinical response.


OBJECTIVE
This multicenter study was carried out to compare the efficacy and safety of flunisolide, administered via AeroChamber, with budesonide, administered via Turbuhaler, in the treatment of moderate asthma.


METHODS
Patients with moderate asthma, defined as an FEV1 of 40% to 85% of predicted, underwent a 2-week run-in period during which beclomethasone, 750 microg twice daily by MDI, was administered, along with salbutamol prn. Patients (n = 176) were then randomized into two groups. One group received flunisolide administered via AeroChamber, 750 microg (3 puffs), twice daily. The second group received budesonide administered via Turbuhaler, 600 microg (3 puffs), twice daily. All patients took salbutamol prn.


RESULTS
At the end of the 6-week treatment period, there were no significant differences (P > .05 for all comparisons) in efficacy between the groups as evaluated by any efficacy parameter. The treatment groups also did not differ significantly in the number of adverse events or in the incidence of oropharyngeal Candida infection.


CONCLUSIONS
Flunisolide administered by AeroChamber and budesonide administered via Turbuhaler demonstrate similar efficacy and safety in the treatment of moderate asthma.
Newhouse
M
M
Firestone Chest/Allergy Unit, St. Joseph's Hospital/McMaster Faculty of Health Sciences, Hamilton, Ontario, Canada.
Knight
A
A
Wang
S
S
Newman
K
K
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D001249:Asthma / Q000188:drug therapy*; D019819:Budesonide / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D004361:Drug Tolerance; D005260:Female; D005446:Fluocinolone Acetonide / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers / Q000706:statistics & numerical data; D013810:Therapeutic Equivalency
D005446:Fluocinolone Acetonide; D019819:Budesonide; C007734:flunisolide; D006854:Hydrocortisone