A double-blind, placebo-controlled steroid-sparing study with budesonide Turbuhaler in Japanese oral steroid-dependent asthma patients. Japanese Pulmicort Turbuhaler study group.
OBJECTIVE
The aim of this study was to evaluate the oral steroid-sparing capacity of budesonide Turbuhaler.


METHODS
One hundred and thirteen oral steroid-dependent patients were treated for 6 months with placebo or budesonide 800 microg or 1600 microg daily. Every second week the oral steroid dose was reduced if asthma control permitted.


RESULTS
The reductions in oral steroid doses were 9, 35 and 60% in the placebo and budesonide 800 microg and 1600 microg groups, respectively. Oral steroid treatment could be discontinued in 4% (placebo), 15% (800 microg) and 23% (1600 microg). Mean peak expiratory flow values increased by 21 and 24 L/min in the budesonide groups but decreased by 6 L/min in the placebo group. Asthma attack, activity and sleep scores remained unchanged showing maintained efficacy. Plasma cortisol levels increased and an adrenocorticotropic hormone test showed improved adrenocortical response in both budesonide groups, indicating improved safety. Adverse drug reactions were infrequent and mild in all study groups.


CONCLUSIONS
Budesonide Turbuhaler, 800 microg and 1600 microg daily, resulted in a significant reduction in oral steroid usage in steroid-dependent patients. The effect was achieved with maintained asthma control together with improvements in lung and adrenal functions.
Miyamoto
T
T
National Sagamihara Hospital, Japan.
Takahashi
T
T
Nakajima
S
S
Makino
S
S
Yamakido
M
M
Mano
K
K
Nakashima
M
M
Tollemar
U
U
Selroos
O
O
D000280:Administration, Inhalation; D000284:Administration, Oral; D000293:Adolescent; D000324:Adrenocorticotropic Hormone; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects; D003627:Data Interpretation, Statistical; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D007564:Japan; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D010366:Peak Expiratory Flow Rate; D010919:Placebos; D011239:Prednisolone / Q000008:administration & dosage*; D011446:Prospective Studies; D012890:Sleep / Q000187:drug effects
D000893:Anti-Inflammatory Agents; D001993:Bronchodilator Agents; D005938:Glucocorticoids; D010919:Placebos; D019819:Budesonide; D000324:Adrenocorticotropic Hormone; D011239:Prednisolone; D006854:Hydrocortisone