TREATMENT OF IDIOPATHIC BRONCHIECTASIS WITH AEROSOLIZED RECOMBINANT HUMAN DNASE-I

Study objective: To study the safety and efficacy of aerosolized recom binant human DNase I in the treatment of idiopathic bronchiectasis. De sign: Double-blind, randomized, placebo-controlled, multicenter study. Populations: Three hundred forty-nine adult outpatients in stable con dition with idiopathic bronchiectasis from 23 centers in North America , Great Britain, and Ireland. Interventions and measurements: Study pa tients received aerosolized rhDNase or placebo twice daily for 24 week s. Primary end points were incidence of pulmonary exacerbations and me an percent change in FEV1 from baseline over the treatment period. Res ults: Pulmonary exacerbations were more frequent and FEV1 decline was greater in patients who received rhDNase compared with placebo during this 24-week trial. Conclusions: rhDNase was ineffective and potential ly harmful in this group of adult outpatients in stable condition with idiopathic bronchiectasis. This contrasts with previously published r esults that demonstrated efficacy of rhDNase in patients with cystic f ibrosis bronchiectasis.