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

Chest. 1998 May;113(5):1329-34. doi: 10.1378/chest.113.5.1329.

Abstract

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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Inhalation
  • Aerosols
  • Bronchiectasis / drug therapy*
  • Deoxyribonuclease I / administration & dosage*
  • Deoxyribonuclease I / adverse effects
  • Deoxyribonuclease I / therapeutic use
  • Double-Blind Method
  • Drug Administration Schedule
  • Expectorants / administration & dosage*
  • Expectorants / adverse effects
  • Expectorants / therapeutic use
  • Female
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / therapeutic use
  • Spirometry
  • Time Factors
  • Treatment Failure

Substances

  • Aerosols
  • Expectorants
  • Recombinant Proteins
  • DNASE1 protein, human
  • Deoxyribonuclease I