INTRODUCTION: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. STUDY DESIGN: 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). PATIENTS AND INTERVENTIONS: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.
RCT Entities:
INTRODUCTION: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 (IBHFA) has been developed as an alternative to the MDI containing chlorofluorocarbon (IB CFC). OBJECTIVE: To compare the long-term safety and efficacy of IBHFA and IB CFC in patients with COPD. STUDY DESIGN: 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). PATIENTS AND INTERVENTIONS:Patients (n = 456) with moderate-to-severe COPD, who received either IBHFA (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% IBHFA, 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 IBHFA 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 IBHFA and IB CFC, respectively. CONCLUSIONS:IBHFA 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: T A Seemungal; G C Donaldson; E A Paul; J C Bestall; D J Jeffries; J A Wedzicha Journal: Am J Respir Crit Care Med Date: 1998-05 Impact factor: 21.405
Authors: R J Dockhorn; D E Wagner; G L Burgess; K B Hafner; K Letourneau; G L Colice; N M Klinger Journal: Ann Allergy Asthma Immunol Date: 1997-07 Impact factor: 6.347
Authors: N M Siafakas; P Vermeire; N B Pride; P Paoletti; J Gibson; P Howard; J C Yernault; M Decramer; T Higenbottam; D S Postma Journal: Eur Respir J Date: 1995-08 Impact factor: 16.671