PMID- 23340924
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20130207
LR  - 20231111
IS  - 1173-2563 (Print)
IS  - 1173-2563 (Linking)
VI  - 23
IP  - 3
DP  - 2003
TI  - One-Year Evaluation of the Safety and Efficacy of Ipratropium Bromide HFA and CFC 
      Inhalation Aerosols in Patients with Chronic Obstructive Pulmonary Disease.
PG  - 181-91
LID - 10.2165/00044011-200323030-00004 [doi]
AB  - 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 42microg 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.
FAU - Brazinsky, Shari A
AU  - Brazinsky SA
AD  - Institute of Healthcare Assessment, Inc., San Diego, California, USA.
FAU - Lapidus, Robert J
AU  - Lapidus RJ
FAU - Weiss, Laurence A
AU  - Weiss LA
FAU - Ghafouri, Mo
AU  - Ghafouri M
FAU - Fagan, Nora M
AU  - Fagan NM
FAU - Witek, Theodore J
AU  - Witek TJ
CN  - ROVENT HFA Study Group
LA  - eng
PT  - Journal Article
PL  - New Zealand
TA  - Clin Drug Investig
JT  - Clinical drug investigation
JID - 9504817
EDAT- 2003/03/01 00:00
MHDA- 2003/03/01 00:01
CRDT- 2013/01/24 06:00
PHST- 2013/01/24 06:00 [entrez]
PHST- 2003/03/01 00:00 [pubmed]
PHST- 2003/03/01 00:01 [medline]
AID - 10.2165/00044011-200323030-00004 [doi]
PST - ppublish
SO  - Clin Drug Investig. 2003;23(3):181-91. doi: 10.2165/00044011-200323030-00004.