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Am. J. Respir. Crit. Care Med., Volume 159, Number 1, January 1999, 79-86

The Effects of Regular Inhaled Formoterol, Budesonide, and Placebo on Mucosal Inflammation and Clinical Indices in Mild Asthma

ANNIKA WALLIN, THOMAS SANDSTRÖM, MARGARETHA SÖDERBERG, PETER HOWARTH, BO LUNDBÄCK, GIOVANNI DELLA-CIOPPA, SUSAN WILSON, MARY JUDD, RATKO DJUKANOVIC, STEPHEN HOLGATE, ANNE LINDBERG, LARS LARSSEN, Mary Judd, and Bo Melander

Department of Respiratory Medicine and Allergy, University Hospital, and National Institute of Occupational Health, Medical Division, Umeå, Sweden; Immunopharmacology, University Medicine, Southampton General Hospital, Southampton, United Kingdom; Department of Pulmonary Medicine Boden and Östersund Sweden; Novartis, Horsham, UK and Stockholm, Sweden

The present study was designed to observe the effects of 8 wk of treatment with formoterol (Foradil) 24 µg, budesonide 400 µg, and matched placebo inhaled twice a day on inflammatory indices in the bronchial mucosa of 64 patients with mild atopic asthma. Biopsies were obtained at the start and 1 wk before stopping a 9-wk period of treatment, and inflammatory cell numbers were assessed in the submucosa and epithelium by immunohistochemistry. Regular formoterol significantly reduced the number of submucosal mast cells, with a similar trend for eosinophils but not activated T cells. A subgroup analysis conducted in biopsies with >=  10 eosinophils per mm2 revealed a significant reduction in eosinophil numbers when compared with both pretreatment baseline (p < 0.01) and changes after placebo (p < 0.01). Parallel, but less pronounced, effects were observed on mast cell but not on CD25+ T cell numbers. There was no effect of any of the three treatments on BAL levels of mast cell or eosinophil mediators. We conclude that regular treatment with inhaled formoterol reduces rather than increases inflammatory cells in the mucosa of asthmatic patients. It is possible that these cellular effects of formoterol may contribute to the therapeutic efficacy of this drug when used regularly in the treatment




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