An Evaluation of Colchicine as an Alternative to Inhaled Corticosteriods in Moderate Asthma

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Abstract
Colchicine demonstrates an array of anti-inflammatory properties of potential relevance to asthma. However, the efficacy of colchicine as an alternative to inhaled corticosteroid therapy for asthma is unknown. Five centers participated in a controlled trial testing the hypothesis that in patients with moderate asthma needing inhaled corticosteroids for control, colchicine provides therapeutic benefit as measured by maintenance of control when inhaled steroids are discontinued. Subjects were stabi- lized on triamcinolane acetonide (800 m g daily) and then enrolled in a 2-wk run-in during which all subjects took both colchicine (0.6 mg/twice a day) and triamcinolone. At the end of the run-in, all subjects discontinued triamcinolone and were randomized to continued colchicine (n 5 35) or pla- cebo (n 5 36) for a 6-wk double-blind treatment period. The treatment groups were similar in terms of disease severity. After corticosteroid withdrawal, 60% of colchicine-treated and 56% of placebo- treated subjects were considered treatment failures as defined by preset criteria. No significant dif- ference in survival curves was found between treatment groups (log rank 5 0.38). Other measures, including changes in FEV 1 , peak expiratory flow, symptoms, rescue albuterol use, and quality of life scores, also did not differ between groups. Of note, subjects failing treatment had significantly greater methacholine responsiveness at baseline than did survivors (PC 20 , 0.81 6 1.38 versus 2.11 6 2.74 mg/ml; p 5 0.01). An analysis of treatment failures suggested that the criteria selected for fail- ure reflected a clinically meaningful but safe level of deterioration. We conclude that colchicine is no better than placebo as an alternative to inhaled corticosteroids in patients with moderate asthma. Additionally, we conclude that the use of treatment failure as the primary outcome variable in an asthma clinical trial where treatment is withdrawn is feasible and safe under carefully monitored con- ditions. Fish JE, Peters SP, Chambers CV, McGeady SJ, Epstein KR, Boushey HA, Cherniack RM, Chinchilli VM, Drazen JM, Fahy JV, Hurd SS, Israel E, Lazarus SC, Lemanske RF, Martin RJ, Mauger EA, Sorkness C, Szefler SJ, for the National Heart, Lung, and Blood Institute's Asthma Clinical Research. An evaluation of colchicine as an alternative to inhaled corticos- teroids in moderate asthma. AM J RESPIR CRIT CARE MED 1997;156:1165-1171.