Chest
Clinical InvestigationsASTHMABudesonide and Formoterol in a Single Inhaler Improves Asthma Control Compared With Increasing the Dose of Corticosteroid in Adults With Mild-to-Moderate Asthma
Section snippets
Materials and Methods
This was a double-blind, randomized, parallel-group, multinational study conducted at 51 centers in the Czech Republic, Hungary, Norway, Poland, South Africa, Sweden, and United Kingdom. The study was performed in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines, and local regulations, each study center having received ethical approval of the protocol prior to study commencement. All patients gave written informed consent.
Results
Of the 494 patients who entered the open 2-week run-in period, 467 patients (200 men and 267 women) aged 18 to 78 years (mean, 41 years) were randomized to the study. A total of 37 patients discontinued the study: 15 patients in the budesonide/formoterol group (6 with asthma deterioration, 3 with adverse events, and 6 for other reasons) and 22 patients in the budesonide-alone group (5 with asthma deterioration, 3 with adverse events, and 14 for other reasons).
Overall, baseline demographics and
Discussion
The results of this study demonstrate that patients with mild-to-moderate asthma not fully controlled on low doses of inhaled corticosteroid (200 μg/d) benefit significantly from treatment with low-dose budesonide/formoterol compared with raising the dose of corticosteroid alone. These results provide further evidence in support of adding a long-acting β2-agonist to low-dose inhaled corticosteroid before increasing the dose of inhaled corticosteroid in patients who are not fully controlled on
ACKNOWLEDGMENT
The authors thank Caroline Hewitt for coordinating the data from AstraZeneca and author contributions from the seven countries in this multinational study, and the patients in the 51 participating centers in the Czech Republic, Hungary, Norway, Poland, South Africa, Sweden, and United Kingdom.
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This work was funded by AstraZeneca, Lund, Sweden.
Professor Lalloo was sponsored by AstraZeneca to present the data from this study at the European Respiratory Society meeting in Berlin 2001. Professor Thomson has received funding from AstraZeneca and GlaxoSmithKline to attend meetings of the American Thoracic Society, and funding from GlaxoSmithKline, AstraZeneca, and Merck for a member of staff to attend scientific meetings. Professor Thomson has also received research funds for clinical trials from AstraZeneca, GlaxoSmithKline, Novartis, and Merck.