title: Bronchodilator efficacy of tiotropium-formoterol via single pressurized meter dose inhaler (pMDI) versus tiotropium alone in COPD.
abstract: BACKGROUND
  Bronchodilators form the main stay of treatment for COPD. When symptoms are not adequately controlled with one bronchodilator, addition of another bronchodilator is recommended. We have recently developed a combination of tiotropium and formoterol in a single pressurized metered dose inhaler (pMDI) (Cipla Ltd., India). The aim of this study was to compare the bronchodilator effects of a single dose of 18 mcg of tiotropium versus a single dose of a combination of 18 mcg tiotropium plus 12 mcg formoterol administered via a pMDI in subjects with moderate-to-severe COPD.
  
  
  METHODS
  44 COPD subjects were enrolled in this randomized, double-blind, multi-centre, cross-over study. 18 mcg tiotropium and 18 mcg tiotropium plus 12 mcg formoterol were administered via pressurized metered dose inhalers on two separate days. FEV(1), FVC and Inspiratory capacity (IC) were measured before, 15, 30 min, 1, 2, 3, 4, 6, 8, 12 and 24 h after the study drugs were administered.
  
  
  RESULTS
  Compared with tiotropium alone, a combination of tiotropium plus formoterol showed a faster onset of bronchodilator response (p < 0.01 for FEV(1) and FVC), a greater mean maximum change in FEV(1) (p = 0.01) and FVC (p = 0.008) and greater AUC(0-24h) values for FEV(1), FVC and IC. Trough FEV(1) and FVC values were also greater in the combination group.
  
  
  CONCLUSIONS
  A combination of tiotropium plus formoterol administered via a single inhaler produced a superior bronchodilator response than tiotropium alone over a period of 24 h.
authors.affiliation: Chest Research Foundation, Marigold, Kalyaninagar, Pune 411014, India.
authors.forename: Sundeep
authors.initials: S
authors.lastname: Salvi
authors.affiliation: Chest Research Foundation, Marigold, Kalyaninagar, Pune 411014, India. Electronic address: bbrashier@crfindia.com.
authors.forename: Bill
authors.initials: B
authors.lastname: Brashier
authors.affiliation: Department of Respiratory Medicine, BYL Nair Hospital, Mumbai, India.
authors.forename: Dipti
authors.initials: D
authors.lastname: Gothi
authors.affiliation: Department of Respiratory Medicine, BYL Nair Hospital, Mumbai, India.
authors.forename: Vinaya
authors.initials: V
authors.lastname: Karkhanis
authors.affiliation: Chest Research Foundation, Marigold, Kalyaninagar, Pune 411014, India.
authors.forename: Sapna
authors.initials: S
authors.lastname: Madas
authors.affiliation: Cipla Ltd., Mumbai, India.
authors.forename: Jaideep
authors.initials: J
authors.lastname: Gogtay
authors.affiliation: Department of Respiratory Medicine, BYL Nair Hospital, Mumbai, India.
authors.forename: Jyotsna
authors.initials: J
authors.lastname: Joshi
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004983:Ethanolamines / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005541:Forced Expiratory Volume; D000068759:Formoterol Fumarate; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D012602:Scopolamine Derivatives / Q000008:administration & dosage / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013997:Time Factors; D000069447:Tiotropium Bromide; D016896:Treatment Outcome
chemical_list: D001993:Bronchodilator Agents; D004983:Ethanolamines; D012602:Scopolamine Derivatives; D000068759:Formoterol Fumarate; D000069447:Tiotropium Bromide
keywords: COPD; Formoterol; Tiotropium