title: Extrafine beclomethasone/formoterol combination via a dry powder inhaler (NEXThaler(®)) or pMDI and beclomethasone monotherapy for maintenance of asthma control in adult patients: A randomised, double-blind trial.
abstract: BACKGROUND
  The fixed combination of extrafine beclomethasone dipropionate and formoterol fumarate (BDP/FF) pMDI (Foster(®)) is approved for treatment of adult asthmatic patients. In order to provide an alternative drug delivery system for BDP/FF to physicians and patients, a dry powder inhaler (NEXThaler(®)) has been developed, capable to deliver extrafine particles to the lungs and therefore improve the dosing of the drugs, especially in patients with poor hand-breath coordination.
  
  
  OBJECTIVE
  This trial was performed to compare efficacy and safety of extrafine BDP/FF NEXThaler(®) with extrafine BDP/FF pMDI or non-extrafine BDP DPI alone in adult patients with controlled asthma.
  
  
  METHODS
  In this 8-week randomised, double-blind, parallel-group trial, patients were randomized to receive either extrafine BDP/FF NEXThaler(®) 100/6 μg bid, extrafine BDP/FF 100/6 μg pMDI bid or non-extrafine BDP DPI 100 μg bid. The primary efficacy variable was change from baseline to the entire 8-week randomised treatment period in average pre-dose morning PEF.
  
  
  RESULTS
  The ITT population comprised 754 patients. Extrafine BDP/FF NEXThaler(®) was non-inferior (pre-defined margin: -15 L/min) relative to extrafine BDP/FF pMDI (mean difference: -1.84; 95% CI: -6.73, 3.05) in terms of the primary efficacy variable, change from baseline in average pre-dose morning PEF. Statistical superiority of both extrafine BDP/FF formulations over non-extrafine BDP DPI was demonstrated for the primary efficacy variable (providing evidence of assays sensitivity of the trial), ACQ score and percentage of rescue medication use-free days. No significant safety signals were observed.
  
  
  CONCLUSIONS
  NEXThaler(®) is an effective and well-tolerated delivery device for treatment of patients with asthma who need a regular treatment.
authors.affiliation: Practice for Allergy and Family Medicine, Reinfeld, Germany. Electronic address: f.kanniess@gpr-reinfeld.de.
authors.forename: Frank
authors.initials: F
authors.lastname: Kanniess
authors.affiliation: Chiesi Farmaceutici S.p.A., Parma, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Scuri
authors.affiliation: Chiesi Farmaceutici S.p.A., Parma, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Vezzoli
authors.affiliation: Chiesi S.A., Courbevoie, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Francisco
authors.affiliation: Chiesi Farmaceutici S.p.A., Parma, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Petruzzelli
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D001507:Beclomethasone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D058995:Dry Powder Inhalers; D004983:Ethanolamines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D010316:Particle Size; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018927:Anti-Asthmatic Agents; D004983:Ethanolamines; D001507:Beclomethasone; D000068759:Formoterol Fumarate
keywords: Asthma; Extrafine DPI; NEXThaler; pMDI