title: Assessment of lung deposition and analysis of the effect of fluticasone/salmeterol hydrofluoroalkane (HFA) pressurized metered dose inhaler (pMDI) in stable persistent asthma patients using functional respiratory imaging.
abstract: Unambiguously for inhaled products, PK measures are best suited for ensuring that the total systemic exposure is equivalent for two products but cannot provide regional information about lung deposition and structural changes. Functional respiratory imaging (FRI) has been demonstrated to be sensitive for distinguishing small but imperative differences related to a single treatment.
  
  
  
  In this study FRI is used in 16 asthmatic patients to assess equivalence in regional deposition for two products (fluticasone/salmeterol, test and reference) by directly measuring regional functional and structural changes within the lungs following its administration.
  
  
  
  No differences were observed between the lung deposition patterns and the effects on lung structure and function of two products, having the same formulation and manufactured by different organizations using FRI.
  
  
  
  Results using FRI complement PK assessments. The added value of this approach to the conventional clinical methods could be significant.
authors.affiliation: a Department of Respiratory Medicine , FLUIDDA NV , Kontich , Belgium.
authors.forename: J
authors.initials: J
authors.lastname: De Backer
authors.affiliation: a Department of Respiratory Medicine , FLUIDDA NV , Kontich , Belgium.
authors.forename: C
authors.initials: C
authors.lastname: Van Holsbeke
authors.affiliation: a Department of Respiratory Medicine , FLUIDDA NV , Kontich , Belgium.
authors.forename: W
authors.initials: W
authors.lastname: Vos
authors.affiliation: a Department of Respiratory Medicine , FLUIDDA NV , Kontich , Belgium.
authors.forename: S
authors.initials: S
authors.lastname: Vinchurkar
authors.affiliation: b Global Clinical Development , Cipla Ltd ., Mumbai , India.
authors.forename: P
authors.initials: P
authors.lastname: Dorinsky
authors.affiliation: c Research and Development , Cipla Ltd , Mumbai , India.
authors.forename: J
authors.initials: J
authors.lastname: Rebello
authors.affiliation: c Research and Development , Cipla Ltd , Mumbai , India.
authors.forename: M
authors.initials: M
authors.lastname: Mangale
authors.affiliation: d Department of Respiratory Medicine , Antwerp University Hospital , Antwerp , Belgium.
authors.forename: B
authors.initials: B
authors.lastname: Hajian
authors.affiliation: d Department of Respiratory Medicine , Antwerp University Hospital , Antwerp , Belgium.
authors.forename: W
authors.initials: W
authors.lastname: De Backer
mesh_terms: D000368:Aged; D001249:Asthma / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000378:metabolism*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination / Q000008:administration & dosage / Q000493:pharmacokinetics*; D006801:Humans; D008168:Lung / Q000000981:diagnostic imaging / Q000378:metabolism*; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D014057:Tomography, X-Ray Computed
chemical_list: D001993:Bronchodilator Agents; D000068297:Fluticasone-Salmeterol Drug Combination
keywords: Functional respiratory imaging; asthma; fluticasone propionate; lung deposition; salmeterol