title: One-Year Evaluation of the Safety and Efficacy of Ipratropium Bromide HFA and CFC Inhalation Aerosols in Patients with Chronic Obstructive Pulmonary Disease.
abstract: BACKGROUND
  Ipratropium bromide (IB) is an established and effective first-line maintenance treatment for patients with chronic obstructive pulmonary disease (COPD). A new IB metered-dose inhaler (MDI) using hydrofluoroalkane 134a propellant (IB HFA) has been developed as an alternative to the MDI containing chlorofluorocarbon (IB CFC).
  
  
  OBJECTIVE
  To compare the long-term safety and efficacy of IB HFA and IB CFC in patients with COPD.
  
  
  METHODS
  This was a randomised, open-label, parallel-group, 1-year, multi-centre trial. Primary endpoints included adverse events (AEs) and vital signs. Secondary endpoints included therapeutic response (>15% increase in forced expiratory volume in 1 second [FEV(1)] peak change from baseline), FEV(1) area under the response-time curve (AUC).
  
  
  METHODS
  Patients (n = 456) with moderate-to-severe COPD, who received either IB HFA (n = 305) or IB CFC (n = 151 ), both 42µg four times daily.
  
  
  RESULTS
  There were no significant differences in the incidences of individual AEs between groups over the short and long term; respiratory disorders were the most common. The incidence of anticholinergic AEs possibly related to treatment was low (1.3% IB HFA, 0.7% IB CFC). Serious AEs occurred in 19.0% and 20.5%, and discontinuations due to AEs in 7.2% and 7.3%, of patients receiving IB HFA and IB CFC, respectively. Therapeutic bronchodilatory responses were achieved in 76-81% and 72-84% of patients, and AUC ranged from 0.117-0.148L and 0.117-0.174L, in patients receiving IB HFA and IB CFC, respectively.
  
  
  CONCLUSIONS
  IB HFA had similar efficacy and tolerability to IB CFC over 1 year, supporting a seamless transition from the CFC MDI to the HFA MDI in both short- and long-term treatment.
authors: Institute of Healthcare Assessment, Inc., San Diego, California, USA.
authors: Shari A
authors: SA
authors: Brazinsky
authors: Robert J
authors: RJ
authors: Lapidus
authors: Laurence A
authors: LA
authors: Weiss
authors: Mo
authors: M
authors: Ghafouri
authors: Nora M
authors: NM
authors: Fagan
authors: Theodore J
authors: TJ
authors: Witek