Clinical comparison of inhaled budesonide delivered either via pressurized metered dose inhaler or Turbuhaler.
The aim of this open, randomized cross-over study was to compare the efficacy and safety of inhaled budesonide administered either via a pressurized metered dose inhaler with a 750 ml spacer attached, or via a new dry powder inhaler, Turbuhaler, in 28 patients with stable bronchial asthma. During the 2-week run-in period, the patients received their ordinary inhaled steroid treatment. This was followed by two 4-week periods of active treatment with inhaled budesonide given via Turbuhaler or pressurized MDI. The patients were divided into two groups according to their previous, inhaled steroid doses. Group A received 400 micrograms of budesonide b.i.d, and Group B 800 micrograms of budesonide b.i.d. Diary cards were used by the patients at home to report asthma symptoms, beta 2-agonist consumption, and PEF twice daily, as well as the number of coughs experienced in a 5-min period after steroid inhalation. Budesonide Turbuhaler produced a significantly better effect on morning peak flow than budesonide MDI. The number of coughs in the 5 min after steroid inhalation was significantly lower with the Turbuhaler than with the MDI. In all other parameters recorded (e.g. FEV1, evening PEF, histamine PC20 and other diary measurements) there were no statistically significant differences between the two devices. Turbuhaler was significantly more appreciated than MDI in all questions of preference. The study showed that budesonide via Turbuhaler was at least as effective and safe as budesonide via a pressurized MDI at daily doses of 800 and 1,600 micrograms.(ABSTRACT TRUNCATED AT 250 WORDS)
Engel
T
T
Medical Department TTA, State University Hospital, Copenhagen, Denmark.
Heinig
J H
JH
Malling
H J
HJ
Scharling
B
B
Nikander
K
K
Madsen
F
F
D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D019819:Budesonide; D002986:Clinical Trials as Topic; D006801:Humans; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D011282:Pregnenediones / Q000008:administration & dosage* / Q000494:pharmacology; D011897:Random Allocation
D011282:Pregnenediones; D019819:Budesonide