Document Detail


Fluticasone propionate 100 microg bid using a non-CFC propellant, HFA 134a, in asthmatic children.
MedLine Citation:
PMID:  12687029     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Secondary to phasing out chlorofluorocarbons (CFCs), the fluticasone propionate (FP) pressurized metered-dose inhaler has been formulated in a nonozone-depleting propellant, hydrofluoralkane (HFA) 134a. OBJECTIVES: To demonstrate equivalent efficacy and safety of FP 200 microg daily propelled by HFA 134a to FP 200 microg daily propelled by CFCs 11 and 12 over a four-week treatment period in pediatric asthmatic patients. METHODS: The study was multinational, randomized, double blind and of parallel group design. Eligible patients aged 16 years and younger were steroid naive or receiving 500 microg/day or less of beclomethasone dipropionate, budesonide or flunisolide, or 250 microg/day or less of inhaled FP. The primary efficacy variable was mean morning peak expiratory flow with equivalence determined if the 90% CIs for the treatment differences between groups were within +/- 15 L/min. RESULTS: Three hundred fifteen patients (mean age 9.3 +/- 2.8 years) were randomly assigned; 158 patients received FP HFA 134a and 157 patients received FP CFC. Over the four-week treatment period, mean morning peak expiratory flow increased from baseline in both groups (14 L/min and 17 L/min, respectively), with a mean treatment difference of -2 L/min. Equivalence was demonstrated between the groups (90% CI -6 to +3 L/min; P=0.589). Both formulations were well tolerated with no serious drug-related events. CONCLUSIONS: FP propelled by HFA 134a has equivalent efficacy and comparable safety to FP propelled by CFC propellants at a microgram equivalent dose in pediatric asthmatic patients.
Authors:
Brian Lyttle; John Gilles; Maarja Panov; Andrzej Emeryk; Claire Wixon
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Canadian respiratory journal : journal of the Canadian Thoracic Society     Volume:  10     ISSN:  1198-2241     ISO Abbreviation:  Can. Respir. J.     Publication Date:  2003 Mar 
Date Detail:
Created Date:  2003-04-10     Completed Date:  2003-07-01     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9433332     Medline TA:  Can Respir J     Country:  Canada    
Other Details:
Languages:  eng     Pagination:  103-9     Citation Subset:  IM    
Affiliation:
Department of Paediatrics, Children's Hospital of Western Ontario, London, Canada.
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MeSH Terms
Descriptor/Qualifier:
Administration, Inhalation
Adolescent
Androstadienes / administration & dosage*
Asthma / diagnosis,  drug therapy*
Child
Child, Preschool
Confidence Intervals
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Female
Follow-Up Studies
Forced Expiratory Volume
Humans
Hydrocarbons, Fluorinated / administration & dosage*
Male
Nebulizers and Vaporizers
Probability
Respiratory Function Tests
Severity of Illness Index
Treatment Outcome
Chemical
Reg. No./Substance:
0/Androstadienes; 0/Hydrocarbons, Fluorinated; 431-89-0/HFA 134a; 90566-53-3/fluticasone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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