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Published online before print February 2, 2006
Eur Respir J 2006, doi:10.1183/09031936.06.00102605
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ORIGINAL ARTICLE

A randomised comparison of the effects of asthma treatment given in addition to inhaled corticosteroids on airway inflammation and airway responsiveness

R.H. Green 1*, C.E. Brightling 1, S. McKenna 1, B. Hargadon 1, N. Neale 1, D. Parker 1, C. Ruse 1, I.P. Hall 2, I.D. Pavord 1

1 Institute for Lung Health, Dept of Respiratory Medicine and Thoracic Surgery, Glenfield Hospital, Groby Road, Leicester LE3 9PQ
2 Division of Therapeutics, Queens Medical Centre, Nottingham, UK

* To whom correspondence should be addressed. E-mail: ruth.green{at}uhl-tr.nhs.uk.


  Abstract

There is increasing evidence that assessment of eosinophilic airway inflammation using induced sputum and measurement of airway hyperresponsiveness provides additional, clinically important information about asthma control. We aimed to directly compare the effects of different treatments on these markers in patients with asthma with persistent symptoms despite low dose inhaled corticosteroids.

We performed a double-blind 4-way cross-over study comparing 1 months treatment with budesonide 400 mcg bd, additional formoterol, additional montelukast and placebo in 49 patients with uncontrolled asthma despite budesonide 100 mcg bd, each treatment separated by a 4-week washout.

The change in sputum eosinophil count with formoterol (2.4% to 3.8%; fold reduction 0.6;95% CI 0.5,0.9) differed significantly from placebo (2.8% to 2.5%; fold reduction 1.1;95% CI 0.7,1.6; p=0.03) and high dose budesonide (2.7% to 1.6%; fold reduction 1.6;95% CI 1.2,2.2; p<0.001). The effects of montelukast did not differ from placebo. The changes in methacholine airway responsiveness were small and did not differ between treatments. High dose budesonide had the broadest range of beneficial effects on other outcomes including symptom scores, morning PEF and FEV1.

Treatment given in addition to low dose inhaled corticosteroids results in modest benefits. Formoterol and high dose budesonide have contrasting effects on eosinophilic airway inflammation.

Keywords:  Asthma, inhaled corticosteroids, leukotriene antagonists, long acting {beta}2-agonists, treatment




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