Asthma, Rhinitis, other Respiratory DiseasesEffect of inhaled fluticasone with and without salmeterol on airway inflammation in asthma☆,☆☆
Section snippets
Study design
This was a randomized double-blind, parallel group, control study, which comprised a 2- to 4-week run-in period followed by a 12-week treatment period conducted outside the pollen season. During the run-in period and after treatment, a methacholine bronchial provocation test and fiberoptic bronchoscopy were undertaken. After the first bronchoscopy the subjects were randomized to receive FP 200 μg twice a day (FP 400), 500 μg twice a day (FP 1000), or 200 μg twice a day together with SALM 50 μg
Results
Baseline characteristics of the subjects in the 3 groups were evenly distributed with respect to gender, asthma duration, measures of pulmonary function, and reversibility. For the baseline PC20 there was a significant difference (P < .05) between the subjects randomized to FP 1000 when compared with FP400 (Fig 1).
Fifty-six subjects were randomized, of which 51 underwent both bronchoscopies. Of the 5 who failed to complete the study, 2 were withdrawn because of an asthma exacerbation (FP 1000
Discussion
The present study was designed to test the hypothesis that the addition of the long-acting β2-agonist SALM to a low dose of the inhaled corticosteroid FP has a steroid-sparing effect and does not result in a worsening of bronchial inflammation compared to doubling the dose of inhaled corticosteroid.
By using objective measures of pulmonary function the present study has confirmed previous observations11, 12, 13, 14, 15, 16 that the addition of the long-acting β2-agonist SALM to a low dose of FP
Acknowledgements
We would like to thank Kevin Kane (GlaxoSmithKline) for undertaking the statistical analysis of the clinical data.
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Supported by a grant from Glaxo Wellcome R&D, United Kingdom.
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Reprint requests: Susan Wilson, PhD, Infection, Inflammation and Repair, Mailpoint 810 (RCMB), Level D, Centre Block, Southampton General Hospital, Tremona Road, Southampton, SO16 6YD, United Kingdom.