PMID- 11059947
OWN - NLM
STAT- MEDLINE
DCOM- 20001212
LR  - 20161124
IS  - 0954-6111 (Print)
IS  - 0954-6111 (Linking)
VI  - 94
IP  - 10
DP  - 2000 Oct
TI  - Fenoterol hydrobromide delivered via HFA-MDI or CFC-MDI in patients with asthma: 
      a safety and efficacy comparison.
PG  - 948-53
AB  - The main objective of the study was to compare the long-term safety and 
      tolerability of fenoterol hydrobromide delivered using a metered-dose inhaler 
      formulated with the alternative propellant, hydrofluoroalkane 134a (HFA-MDI), 
      with delivery using the currently available chlorofluorocarbon MDI (CFC-MDI; 
      Berotec 100). A further objective was to compare the efficacy of fenoterol 
      HFA-MDI with fenoterol CFC-MDI, using the pulmonary function parameters of forced 
      expiratory volume in 1 sec (FEV1), forced vital capacity (FVC) and peak 
      expiratory flow (PEF). Following a 2-week run-in phase, a 12-week, double-blind 
      parallel group comparison was undertaken in 290 patients randomized on a 2:1 
      basis to two puffs of 100 microg fenoterol four times a day (HFA-MDI=197 
      patients; CFC-MDI=93 patients). A total of 236 patients in this multi-centre 
      study completed the trial as planned. The overall incidence of adverse events 
      (AEs) was similar in both groups (29.9% of HFA-MDI patients and 28% of CFC-MDI 
      patients). Reports of respiratory disorder AEs were also comparable (21.8% 
      HFA-MDI; 22.6% CFCMDI). End of study laboratory tests, ECG, pulse, blood pressure 
      and physical examination showed no significant differences from pre-study 
      baselines in either group and both treatments appeared to be well tolerated. 
      Pre-dose FEV1 measurements taken at the three clinic visits were constant and 
      increase in FEV1 at 5 and 30 min post-dose demonstrated equivalent efficacy for 
      the two formulations. No difference between the two groups was observed in PEF or 
      in the use of rescue medication. We conclude from these findings that the 
      long-term safety and efficacy profile of fenoterol HFA-MDI is comparable to that 
      of the fenoterol CFC-MDI.
FAU - Goldberg, J
AU  - Goldberg J
AD  - Fachdarztin fur Lungenheilkunde, Allergologie, AMG-GmbH, Schwedt/Oder, Germany.
FAU - Bohning, W
AU  - Bohning W
FAU - Schmidt, P
AU  - Schmidt P
FAU - Freund, E
AU  - Freund E
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (Aerosol Propellants)
RN  - 0 (Bronchodilator Agents)
RN  - 0 (Hydrocarbons, Fluorinated)
RN  - 22M9P70OQ9 (Fenoterol)
RN  - R40P36GDK6 (apaflurane)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aerosol Propellants/*standards
MH  - Aged
MH  - Asthma/*drug therapy
MH  - Bronchodilator Agents/*administration & dosage
MH  - Double-Blind Method
MH  - Female
MH  - Fenoterol/*administration & dosage
MH  - Forced Expiratory Volume/physiology
MH  - Humans
MH  - Hydrocarbons, Fluorinated/*standards
MH  - Male
MH  - Middle Aged
MH  - Nebulizers and Vaporizers
MH  - Peak Expiratory Flow Rate/physiology
MH  - Treatment Outcome
MH  - Vital Capacity/physiology
EDAT- 2000/11/04 11:00
MHDA- 2001/02/28 10:01
CRDT- 2000/11/04 11:00
PHST- 2000/11/04 11:00 [pubmed]
PHST- 2001/02/28 10:01 [medline]
PHST- 2000/11/04 11:00 [entrez]
AID - S0954-6111(00)90864-3 [pii]
AID - 10.1053/rmed.2000.0864 [doi]
PST - ppublish
SO  - Respir Med. 2000 Oct;94(10):948-53. doi: 10.1053/rmed.2000.0864.