title: Investigation of the efficacy of generic and brand-name tiotropium bromide in the management of chronic obstructive pulmonary disease: A randomized comparative trial.
abstract: BACKGROUND
  The beneficial effects of tiotropium bromide, a long acting anticholinergic bronchodilator, in the management of chronic obstructive pulmonary disease have been shown in previous studies. The present study aimed to compare the efficacy and safety of generic (Tiova®) and brand-name (Spiriva®) tiotropium preparations in patients with COPD.
  
  
  METHODS
  In this randomized double-blind parallel-group trial, 79 patients with documented COPD were assigned to Tiova® or Spiriva® for a period of 4 weeks. Assessment of pulmonary function (using spirometry), quality-of-life (using St. George respiratory Questionnaire [SGRQ]) and severity of respiratory symptoms (using breathlessness, cough and sputum scale [BCSS]) was performed at baseline and at the end of treatment period.
  
  
  RESULTS
  There were significant increases in FEV1 and reductions in FVC by the end of study in both Tiova® and Spiriva® groups. FEV1/FVC ratio did not change significantly neither in the Tiova® nor in Spiriva® group. Overall SGRQ score as well as subscale scores of symptoms, activity and impacts were improved by both drugs. In the BCSS scale, the frequency and severity of three main symptoms (dyspnea, cough and sputum) was decreased by both drugs. Baseline as well as post-treatment values of spirometric parameters, SGRQ and BCSS scores was comparable between the groups, apart from a lower post-treatment frequency of cough and sputum in the Spiriva® versus Tiova® group. There was no report of adverse events in either of the study groups.
  
  
  CONCLUSIONS
  The findings of this comparative trial showed equivalent efficacy and safety of Spiriva® and Tiova® in lessening the symptoms as well as improving the quality of life in patients with COPD. This finding has an important translational value given the significantly lower costs of generic versus brand-name products.
authors.affiliation: Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.
authors.forename: Yunes
authors.initials: Y
authors.lastname: Panahi
authors.affiliation: Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.
authors.forename: Mostafa
authors.initials: M
authors.lastname: Ghanei
authors.affiliation: Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Behzadi
authors.affiliation: Chemical Injuries Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.
authors.forename: Maryam
authors.initials: M
authors.lastname: Salehi
authors.affiliation: Neurogenic Inflammation Research Center, Department of Modern Sciences and Technologies, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Sara Saffar
authors.initials: SS
authors.lastname: Soflaei
authors.affiliation: Biotechnology Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Cardiometabolic Research Centre, Royal Perth Hospital, School of Medicine and Pharmacology, University of Western Australia, Perth, Australia.
authors.forename: Amirhossein
authors.initials: A
authors.lastname: Sahebkar
keywords: Anticholinergic; Bronchodilator; Chronic obstructive pulmonary disease; Generic; Randomized controlled trial; Tiotropium bromide