title: Fluticasone/formoterol dry powder versus budesonide/formoterol in adults and adolescents with uncontrolled or partly controlled asthma.
abstract: This 12-week study compared the efficacy and safety of a fixed combination of fluticasone propionate plus formoterol (FL/F) 250/12 μg b.i.d. administered via a dry powder inhaler (DPI) (Libbs Farmacêutica, Brazil) to a combination of budesonide plus formoterol (BD/F) 400/12 μg b.i.d. After a 2-week run-in period (in which all patients were treated exclusively with budesonide plus formoterol), patients aged 12-65 years of age (N = 196) with uncontrolled asthma were randomized into an actively-controlled, open-labeled, parallel-group, multicentre, phase III study. The primary objective was to demonstrate non-inferiority, measured by morning peak expiratory flow (mPEF). The non-inferiority was demonstrated. A statistically significant improvement from baseline was observed in both groups in terms of lung function, asthma control, and the use of rescue medication. FL/F demonstrated a statistical superiority to BD/F in terms of lung function (FEV(1)) (p = 0.01) and for asthma control (p = 0.02). Non-significant between-group differences were observed with regards to exacerbation rates and adverse events. In uncontrolled or partly controlled asthma patients, the use of a combination of fluticasone propionate plus formoterol via DPI for 12-weeks was non-inferior and showed improvements in FEV(1) and asthma control when compared to a combination of budesonide plus formoterol. (
  
  
  BACKGROUND
  ISRCTN60408425).
authors.affiliation: Pulmonary Division, Heart Institute (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Av. Dr. Eneas de Carvalho Aguiar, 44 - bloco I - 1° andar, São Paulo, SP 05403-000, Brazil.
authors.forename: A
authors.initials: A
authors.lastname: Cukier
authors.forename: C M A
authors.initials: CM
authors.lastname: Jacob
authors.forename: N A
authors.initials: NA
authors.lastname: Rosario Filho
authors.forename: J
authors.initials: J
authors.lastname: Fiterman
authors.forename: E O
authors.initials: EO
authors.lastname: Vianna
authors.forename: J L
authors.initials: JL
authors.lastname: Hetzel
authors.forename: M A
authors.initials: MA
authors.lastname: Neis
authors.forename: E
authors.initials: E
authors.lastname: Fiss
authors.forename: F F M
authors.initials: FF
authors.lastname: Castro
authors.forename: A L G
authors.initials: AL
authors.lastname: Fernandes
authors.forename: R
authors.initials: R
authors.lastname: Stirbulov
authors.forename: E
authors.initials: E
authors.lastname: Pizzichini
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000503:physiopathology / Q000517:prevention & control*; D019819:Budesonide / Q000008:administration & dosage / Q000009:adverse effects; D002648:Child; D004338:Drug Combinations; D058995:Dry Powder Inhalers; D004983:Ethanolamines / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D000068298:Fluticasone; D005541:Forced Expiratory Volume / Q000187:drug effects; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D008875:Middle Aged; D010366:Peak Expiratory Flow Rate / Q000187:drug effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000730:Androstadienes; D018927:Anti-Asthmatic Agents; D004338:Drug Combinations; D004983:Ethanolamines; D019819:Budesonide; D000068298:Fluticasone; D000068759:Formoterol Fumarate
keywords: Asthma control questionnaire; Clinical trial; Forced expiratory volume in 1 s; Morning peak expiratory flow; Non-inferiority; Single inhaler