title: Formoterol by pressurized metered-dose aerosol or dry powder on airway obstruction and lung hyperinflation in partially reversible COPD.
abstract: BACKGROUND
  We compared the efficacy and safety of formoterol given by a pressurized metered-dose inhaler (pMDI) (Atimos®, Chiesi Farmaceutici, Italy), using a chlorine-free hydrofluoroalkane (HFA-134a) propellant developed to provide stable and uniform dose delivery (Modulite™, Chiesi Farmaceutici, Italy), with formoterol by dry powder inhaler (DPI) (Foradil® Aerolizer®, Novartis Pharmaceuticals) and placebo, in reducing airflow obstruction and lung hyperinflation, in moderate-to-severe, partially reversible chronic obstructive pulmonary disease (COPD).
  
  
  METHODS
  Forty-eight patients were randomized to a 1-week, double-blind, double-dummy, three-period crossover study with 12 μg b.i.d. of formoterol given by pMDI or DPI, or placebo. Spirometry, specific airway conductance, and lung volumes were measured at the beginning and at the end of each treatment period from predose to 4 h postdose. A 6-min walking test was carried out 4 h after the first and the last dose, with dyspnea assessed by Borg scale. Safety was assessed through adverse events monitoring electrocardiography and vital signs.
  
  
  RESULTS
  The two formulations of formoterol were significantly superior to placebo but not different from each other in increasing 1-sec forced expiratory volume, specific airway conductance, inspiratory capacity, and inspiratory-to-total lung capacity ratio. The two active treatments were also equivalent and superior to placebo in reducing dyspnea at rest and on exertion. No differences in terms of safety between the two active forms and placebo were detected.
  
  
  CONCLUSIONS
  Formoterol given with chlorine-free pMDI was equivalent to DPI in reducing airway obstruction and lung hyperinflation in COPD patients. Both formoterol formulations confirmed the good safety profile similar to placebo.
authors.affiliation: Unità Operativa di Fisiopatologia Respiratoria, Department of Internal Medicine, University of Genoa, Italy.
authors.forename: Vito
authors.initials: V
authors.lastname: Brusasco
authors.forename: G Walter
authors.initials: GW
authors.lastname: Canonica
authors.forename: Roberto
authors.initials: R
authors.lastname: Dal Negro
authors.forename: Giorgio
authors.initials: G
authors.lastname: Scano
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Paggiaro
authors.forename: Leonardo M
authors.initials: LM
authors.lastname: Fabbri
authors.forename: Giovanni
authors.initials: G
authors.lastname: Barisione
authors.forename: Gennaro
authors.initials: G
authors.lastname: D'Amato
authors.forename: Guido
authors.initials: G
authors.lastname: Varoli
authors.forename: Michele
authors.initials: M
authors.lastname: Baroffio
authors.forename: Manlio
authors.initials: M
authors.lastname: Milanese
authors.forename: Carlo
authors.initials: C
authors.lastname: Mereu
authors.forename: Emanuele
authors.initials: E
authors.lastname: Crimi
mesh_terms: D000336:Aerosols; D000368:Aged; D000402:Airway Obstruction / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004983:Ethanolamines / Q000008:administration & dosage*; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D000068759:Formoterol Fumarate; D006801:Humans; D007320:Inspiratory Capacity / Q000187:drug effects* / Q000502:physiology; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D011208:Powders; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications* / Q000503:physiopathology
chemical_list: D000336:Aerosols; D001993:Bronchodilator Agents; D004983:Ethanolamines; D011208:Powders; D000068759:Formoterol Fumarate