Treatment of idiopathic bronchiectasis with aerosolized recombinant human DNase I. rhDNase Study Group.

STUDY OBJECTIVE: To study the safety and efficacy of aerosolized recombinant human DNase I in the treatment of idiopathic bronchiectasis.

DESIGN: Double-blind, randomized, placebo-controlled, multicenter study.

POPULATIONS: Three hundred forty-nine adult outpatients in stable condition with idiopathic bronchiectasis from 23 centers in North America, Great Britain, and Ireland.

INTERVENTIONS AND MEASUREMENTS: Study patients received aerosolized rhDNase or placebo twice daily for 24 weeks. Primary end points were incidence of pulmonary exacerbations and mean percent change in FEV1 from baseline over the treatment period.

RESULTS: 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 potentially harmful in this group of adult outpatients in stable condition with idiopathic bronchiectasis. This contrasts with previously published results that demonstrated efficacy of rhDNase in patients with cystic fibrosis bronchiectasis.