Formoterol by pressurized metered-dose aerosol or dry powder on airway obstruction and lung hyperinflation in partially reversible COPD

Vito Brusasco, G. Walter Canonica, Roberto Dal Negro, Giorgio Scano, Pierluigi Paggiaro, Leonardo M. Fabbri, Giovanni Barisione, Gennaro D'Amato, Guido Varoli, Michele Baroffio, Manlio Milanese, Carlo Mereu, Emanuele Crimi

Research output: Contribution to journalArticle

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?g 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 4h postdose. A 6-min walking test was carried out 4h 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.

Original languageEnglish
Pages (from-to)235-243
Number of pages9
JournalJournal of Aerosol Medicine and Pulmonary Drug Delivery
Volume24
Issue number5
DOIs
Publication statusPublished - Oct 1 2011

Keywords

  • inhaler

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Pharmacology (medical)
  • Pharmaceutical Science

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  • Cite this

    Brusasco, V., Canonica, G. W., Negro, R. D., Scano, G., Paggiaro, P., Fabbri, L. M., Barisione, G., D'Amato, G., Varoli, G., Baroffio, M., Milanese, M., Mereu, C., & Crimi, E. (2011). Formoterol by pressurized metered-dose aerosol or dry powder on airway obstruction and lung hyperinflation in partially reversible COPD. Journal of Aerosol Medicine and Pulmonary Drug Delivery, 24(5), 235-243. https://doi.org/10.1089/jamp.2010.0862