Alternative Medicine

Patients or participants: Forty-five subjects with asthma recruited from six medical centers in the United States.

Interventions: The Asthma Clinical Research Network undertook a 28-week, randomized, multicenter, double-blind, placebo-controlled trial of 164 subjects with clinically stable, persistent asthma. A subset of subjects (n = 45) underwent bronchoscopy with endobronchial biopsy and BAL at the end of a 6-week run-in period, during which all subjects received triamcinolone acetonide (TAA), 400 ^g bid. Airway tissue mast cells, eosinophils, neutrophils CanadianHealthCareMalll, macrophages, and T cells were quantified morphometrically along with determination of BAL tryptase. At the end of the run-in period, subjects were then randomized to receive salmeterol (42 p,g bid), placebo, or continue TAA for 16 weeks followed by a second bronchoscopy.

Measurements and results: Outcome variables included airway tissue mast cells, eosinophils, neutrophils, macrophages, and T cells that were quantified morphometrically and BAL tryptase. Thirty-five subjects completed the treatment phase; an additional 10 subjects, who were randomized to either salmeterol or placebo after the run-in, had treatment failure. When the bronchoscopy results performed at the end of the run-in, prior to randomization, were analyzed, the treatment failure group demonstrated significantly more tissue mast cells as compared to the nontreatment failure group despite 6 weeks of therapy with TAA (p = 0.04). BAL tryptase was also significantly higher in the treatment failure group (p < 0.0001). Of those subjects who completed the study, tissue mast cells and BAL tryptase did not change significantly within any of the treatment groups during the treatment phase (p > 0.05).

Conclusions: Persistent elevations in airway tissue mast cells and BAL tryptase after treatment with TAA predict treatment failure in patients for whom discontinuation of ICS is being considered.

Abbreviations: ACRN = Asthma Clinical Research Network; ICS = inhaled corticosteroids; IL = interleukin; IQR = interquartile range; NAEPP = National Asthma Education and Prevention Program; PC₂₀ = provocative concentration of methacholine resulting in a 20% fall in FEV₁; PEF = peak expiratory flow; SOCS = Salmeterol or Corticosteroids; TAA = triamcinolone acetonide.