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Original Research: ASTHMA |

A Randomized Primary Care Trial of Steroid Titration Against Mannitol in Persistent AsthmaSteroid Titration Against Mannitol: STAMINA Trial

Brian J. Lipworth, MD; Philip M. Short, MBChB; Peter A. Williamson, MBChB; Karine L. Clearie, MD; Thomas C. Fardon, MD; Cathy M. Jackson, MD
Author and Funding Information

From the Asthma and Allergy Research Group (Drs Lipworth, Short, Williamson, Clearie, and Fardon), Ninewells Hospital and Medical School, University of Dundee, Dundee; and the Bute Medical School (Dr Jackson), University of St. Andrews, St. Andrews, Scotland.

Correspondence to: Brian J. Lipworth, MD, Asthma and Allergy Research Group, Ninewells Hospital and Medical School, University of Dundee, Dundee, DD1 9SY, Scotland; e-mail: brianlipworth@gmail.com


Funding/Support: This study was funded from University Departmental grants as well as by Pharmaxis, who supplied mannitol as a gift and donated an unrestricted educational grant. Nycomed supplied the ciclesonide inhalers as a gift and also provided an unrestricted educational grant.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (http://www.chestpubs.org/site/misc/reprints.xhtml).


© 2012 American College of Chest Physicians


Chest. 2012;141(3):607-615. doi:10.1378/chest.11-1748
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Background:  We compared titrating inhaled corticosteroid (ICS) against mannitol airway hyperresponsiveness (AHR) or a reference strategy (control) based on symptoms, reliever use, and lung function in primary care.

Methods:  One hundred sixty-four patients with persistent asthma were randomized in parallel group fashion following an initial ICS tapering. Subsequent ICS doses (as ciclesonide) were titrated against either the provocative dose of mannitol causing a 10% fall in FEV1 (PD10) (AHR strategy) or a control group (reference strategy) over a 1-year period.

Results:  One hundred nineteen participants (n = 61 AHR, n = 58 control) completed the study. Time to first mild exacerbation was not significantly different: hazard ratio, 1.29; 95% CI, 0.716-2.31; P = .40. Although there were 27% fewer total number of mild exacerbations over 12 months in AHR vs control groups (n = 84 vs n = 115, P = .03), there was no difference in severe exacerbations (n = 12 vs n = 13). No other significant differences were seen between groups with the exception of mannitol PD10 and ICS dose. There was a 1.52 (95% CI, 0.61-2.42; P = .001) doubling dose difference in mannitol PD10 between AHR vs control groups. The final mean daily ciclesonide dose was higher (P < .0001) in AHR vs control groups (514 μg vs 208 μg), with no associated significant suppression of overnight urinary cortisol/creatinine. Significant improvements were seen within the AHR group but not the control group for the provocative concentration of methacholine causing a 20% fall in FEV1 (P < .05), salivary eosinophilic cationic protein (P < .05), exhaled nitric oxide (P < .05), symptoms (P < .005), and reliever use (P < .001).

Conclusions:  Mannitol challenge was well tolerated in a primary care setting. Using mannitol resulted in exposure to a higher dose of ciclesonide, which was associated with equivocal effects on exacerbations without associated adrenal suppression. Large-scale trials using mannitol in patients with more severe disease may now be warranted to further define its role.

Trial registration:  ClinicalTrials.gov; No.: NCT01216579; URL: www.clinicaltrials.gov

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