PMID- 15777603
OWN - NLM
STAT- MEDLINE
DCOM- 20050630
LR  - 20161124
IS  - 0954-6111 (Print)
IS  - 0954-6111 (Linking)
VI  - 99 Suppl A
DP  - 2005 Apr
TI  - Salmeterol HFA is as effective as salmeterol CFC in children and adults with 
      persistent asthma.
PG  - S1-S10
AB  - In accordance with the Montreal Protocol 1987, initiatives to phase out and 
      replace ozone-depleting chlorofluorocarbon (CFC) propellants with 
      non-ozone-depleting propellants in metered-dose inhalers (MDIs) in the treatment 
      of asthma and chronic obstructive pulmonary disease are underway. In view of 
      this, two multi-centre, randomised, parallel-group, double-blind studies were 
      conducted to compare the safety and efficacy of salmeterol xinafoate delivered by 
      an MDI using the hydrofluoroalkane (HFA) 134a propellant with the licensed CFC 
      formulation (Serevent) in asthmatic populations of children (4-11 years) and 
      adults (12 years). Patients on a stable dose of inhaled corticosteroids with a 
      scope for improvement based on mean morning peak expiratory flow (PEF) and 
      symptoms were randomised to receive salmeterol HFA MDI 50 microg twice daily or 
      salmeterol CFC MDI 50 microg twice daily for 12 weeks. The primary efficacy 
      variable was mean morning PEF and secondary variables included other lung 
      function parameters, symptom scores, use of relief medication and safety 
      assessments. The difference between the treatments in adjusted mean morning PEF 
      (salmeterol HFA-salmeterol CFC) were 2.5 and -3.2 L/min for per-protocol 
      populations of children and adults, respectively. The lower limit of 95% 
      confidence intervals for both populations was within the pre-defined limit (-15 
      L/min) set for non-inferiority. Similar results were observed in intent-to-treat 
      (ITT) populations. In children, the two formulations resulted in a lack of any 
      statistically significant difference in secondary efficacy parameters. A 
      significant difference at endpoint in clinic forced expiratory volume in 1s was 
      reported in favour of the HFA formulation in the adult population, although the 
      magnitude of this effect was not considered clinically significant. The 
      incidences of adverse events (AEs) were similar for both formulations and 
      populations, and no safety concerns were generated. Together these data 
      demonstrate salmeterol HFA MDI to be as effective as salmeterol CFC MDI in adults 
      and children.
FAU - Chopra, Narinder
AU  - Chopra N
AD  - GlaxoSmithKline Research and Development, Global Commerical Strategy, Respiratory 
      Building 38, 1 floor, Greenford Road, Greenford, Middlesex UB6 0HE, UK.
FAU - Williams, Michael
AU  - Williams M
FAU - Rimmer, Martin
AU  - Rimmer M
FAU - Kahl, Lesley
AU  - Kahl L
FAU - Jenkins, Mair
AU  - Jenkins M
CN  - SMO30006 and SMO30007 International Study Teams
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20050126
PL  - England
TA  - Respir Med
JT  - Respiratory medicine
JID - 8908438
RN  - 0 (Aerosol Propellants)
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Chlorofluorocarbons)
RN  - 0 (Hydrocarbons, Fluorinated)
RN  - 6EW8Q962A5 (Salmeterol Xinafoate)
RN  - QF8SVZ843E (Albuterol)
RN  - R40P36GDK6 (apaflurane)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - *Aerosol Propellants
MH  - Aged
MH  - Albuterol/*administration & dosage/adverse effects/*analogs & derivatives
MH  - Anti-Asthmatic Agents/*administration & dosage/adverse effects
MH  - Asthma/*drug therapy/physiopathology
MH  - Chemical Phenomena
MH  - Chemistry, Physical
MH  - Child
MH  - Child, Preschool
MH  - Chlorofluorocarbons
MH  - Circadian Rhythm
MH  - Double-Blind Method
MH  - Female
MH  - Forced Expiratory Volume/drug effects
MH  - Humans
MH  - Hydrocarbons, Fluorinated
MH  - Male
MH  - Metered Dose Inhalers
MH  - Middle Aged
MH  - Peak Expiratory Flow Rate/drug effects
MH  - Salmeterol Xinafoate
MH  - Treatment Outcome
EDAT- 2005/03/22 09:00
MHDA- 2005/07/01 09:00
CRDT- 2005/03/22 09:00
PHST- 2004/07/02 00:00 [received]
PHST- 2005/03/22 09:00 [pubmed]
PHST- 2005/07/01 09:00 [medline]
PHST- 2005/03/22 09:00 [entrez]
AID - S0954-6111(04)00428-7 [pii]
AID - 10.1016/j.rmed.2004.11.002 [doi]
PST - ppublish
SO  - Respir Med. 2005 Apr;99 Suppl A:S1-S10. doi: 10.1016/j.rmed.2004.11.002. Epub 
      2005 Jan 26.