A randomized primary care trial of steroid titration against mannitol in persistent asthma: STAMINA Trial

Brian J. Lipworth*, Philip M. Short, Peter A. Williamson, Karine L. Clearie, Thomas C. Fardon, Catherine Miriam Jackson

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

43 Citations (Scopus)

Abstract

Background: We compared titrating inhaled corticosteroid (ICS) against mannitol airway hyper-responsiveness (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

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 CHEST 2012; 141(3):607-615

Original languageEnglish
Pages (from-to)607-615
Number of pages9
JournalChest
Volume141
Issue number3
DOIs
Publication statusPublished - Mar 2012

Keywords

  • AIRWAY HYPERRESPONSIVENESS
  • ADENOSINE-MONOPHOSPHATE
  • INHALED CORTICOSTEROIDS
  • DOSE-RESPONSE
  • THERAPY
  • METHACHOLINE
  • INFLAMMATION
  • METAANALYSIS
  • FLUTICASONE
  • CICLESONIDE

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