Sustained bronchoprotection, bronchodilatation, and symptom control during regular formoterol use in asthma of moderate or greater severity☆,☆☆,★
Section snippets
Trial design and treatments
This was a randomized, double-blind, placebo-controlled, parallel-group trial conducted in 15 Canadian centers. Written informed consent was obtained from each participant, and the study protocol was approved by the institutional review board at each clinical center.
After screening, eligible patients entered a 2-week, single-blind, run-in period during which their disease severity was assessed. During this period, patients inhaled placebo dry powder capsules 44 timestimes daily with albuterol
Patient demographic and baseline characteristics
Of 374 patients screened, 271 were randomized, and 217 completed the study. Twenty percent of patients withdrew from the study prematurely, primarily due to adverse events (7%) and protocol violations (5%), with no meaningful differences among treatments (formoterol, 19%; regular albuterol, 21%; and on-demand albuterol, 20%). The 3 treatment groups were similar with respect to demographics, pulmonary function, and daily intake of inhaled corticosteroids at the start of the study (Table I).
DISCUSSION
There is debate in the medical community as to whether long-term, regular use of β2 -agonists (ie, every day at fixed times) is associated with instability or deterioration of asthma control compared with β2 -agonists taken for symptomatic relief only (on demand, as needed, as required).1, 2, 3, 4, 5, 15, 17, 34, 35, 36, 37, 38 Our data show that when patients with asthma of moderate or greater severity inhale formoterol twice daily or albuterol 4 times daily, both regular β2 -agonist
Acknowledgements
We wish to thank the FO/OD1 Study Group and Drs Erhard Quebe-Fehling, Nozhat Chowdry,* Patrick Manning,* Antonia Wang,* and Roger Pierce of Novartis (* = former employees) and Dan Anbar and Izabela Roman of Target Research (Scotch Plains) for their contribution to the design, implementation, and reporting of this trial.
The Canadian FO/OD1 Study Group is as follows: Hôpital Laval Sainte-Foi (Montreal, Quebec): L. P. Boulet, P. Leblanc, F. Maitain (investigators), M. J. Breton, J. Milot
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Supported in part by a grant from Ciba-Geigy Inc (now known as Novartis Inc).
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Reprint requests: Mark FitzGerald, MD, Department of Respiratory Medicine, Mater Misericordiae Hospital, Eccles St, Dublin 7.
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