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1 Karolinska Hospital, Stockholm, Sweden, 2 Mainz University Hospital, Germany, 3 Ullevål Hospital, Oslo, Norway, 4 La Fe University Hospital, Valencia, Spain, 5 Päijät-Häme Central Hospital, Lahti, Finland, 6 Beaumont Hospital, Dublin, Ireland and 7 AstraZeneca, Lund, Sweden
CORRESPONDENCE: O. Zetterström, Karolinska Sjukhuset, Allergicentrum Universitetssjukhuset, S-581 85, Linköping, Sweden.
Keywords: asthma, budesonide, formoterol, glucocorticosteroids, inhalation
Received: July 21, 2000
Accepted March 28, 2001
This study was supported by AstraZeneca, Lund, Sweden.
Budesonide/formoterol in a single inhaler was compared with budesonide alone, and with concurrent administration of budesonide and formoterol from separate inhalers, in patients with asthma, not controlled with inhaled glucocorticosteroids alone.
In this 12-week, double-blind, randomized, double-dummy study, 362 adult asthmatics (forced expiratory volume in one second 73.8% of predicted, inhaled glucocorticosteroid dose 960 µg·day–1) received single inhaler budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5 µg, two inhalations b.i.d., or corresponding treatment with budesonide, or budesonide plus formoterol via separate inhalers.
There was a greater increase in morning peak expiratory flow (PEF) with single-inhaler (35.7 L·min–1) and separate-inhaler (32.0 L·min–1) budesonide and formoterol, compared with budesonide alone (0.2 L·min–1; p<0.001, both comparisons); the effect was apparent after 1 day (p<0.001 versus budesonide, both comparisons). Similarly, evening PEF, use of rescue medication, total asthma symptom scores and percentage of symptom-free days improved more with both single inhaler and separate inhaler therapy than with budesonide alone, as did asthma control days (
It is concluded that single inhaler therapy with budesonide and formoterol is a clinically effective and well-tolerated treatment for patients with asthma that is not fully controlled by inhaled glucocorticosteroids alone.
15% more, p<0.001 versus budesonide, both comparisons, with a marked increase in the first week). All treatments were well tolerated and the adverse event profile was similar in all three treatment groups.
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