title: The lung function profile of once-daily tiotropium and olodaterol via Respimat(®) is superior to that of twice-daily salmeterol and fluticasone propionate via Accuhaler(®) (ENERGITO(®) study).
abstract: BACKGROUND
  Tiotropium + olodaterol has demonstrated improvements beyond lung function benefits in a large Phase III clinical program as a once-daily maintenance treatment for COPD and may be a potential option for the initiation of maintenance treatment in COPD. Despite guideline recommendations that combined long-acting β2-agonists and inhaled corticosteroids should only be used in individuals at high risk of exacerbation, there is substantial use in individuals at lower risk. This raises the question of the comparative effectiveness of this combination as maintenance treatment in this group compared to other combination regimens.
  
  
  OBJECTIVE
  The study aimed to assess the effect on lung function of once-daily tiotropium + olodaterol versus twice-daily salmeterol + fluticasone propionate in all participants with Global initiative for chronic Obstructive Lung Disease 2 or 3 (moderate to severe) COPD.
  
  
  METHODS
  This was a randomized, double-blind, double-dummy, four-treatment, complete crossover study in which participants received once-daily tiotropium + olodaterol (5/5 µg and 2.5/5 µg) via Respimat(®) and twice-daily salmeterol + fluticasone propionate (50/500 µg and 50/250 µg) via Accuhaler(®) for 6 weeks. The primary end point was change in forced expiratory volume in 1 second (FEV1) area under the curve from 0 hour to 12 hours (AUC0-12) relative to the baseline after 6 weeks.
  
  
  RESULTS
  Tiotropium + olodaterol 5/5 µg and 2.5/5 µg demonstrated statistically significant improvements in FEV1 AUC0-12 compared to salmeterol + fluticasone propionate (improvements from baseline were 317 mL and 295 mL with tiotropium + olodaterol 5/5 µg and 2.5/5 µg, and 188 mL and 192 mL with salmeterol + fluticasone propionate 50/500 µg and 50/250 µg, respectively). Tiotropium + olodaterol was superior to salmeterol + fluticasone propionate in lung function secondary end points, including FEV1 area under the curve from 0 hour to 24 hours (AUC0-24).
  
  
  CONCLUSIONS
  Once-daily tiotropium + olodaterol in participants with moderate-to-severe COPD provided superior lung function improvements to twice-daily salmeterol + fluticasone propionate. Dual bronchodilation can be considered to optimize lung function in individuals requiring maintenance treatment for COPD.
authors.affiliation: Insaf GmbH Institut für Atemwegsforschung, Wiesbaden, Germany.
authors.forename: Kai-Michael
authors.initials: KM
authors.lastname: Beeh
authors.affiliation: Department of Internal Medicine, Ghent University Hospital, Ghent, Belgium.
authors.forename: Eric
authors.initials: E
authors.lastname: Derom
authors.affiliation: Servicio de Neumología, Hospital Universitario Quirón, Madrid, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Echave-Sustaeta
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
authors.forename: Lars
authors.initials: L
authors.lastname: Grönke
authors.affiliation: Boehringer Ingelheim, Burlington, ON, Canada.
authors.forename: Alan
authors.initials: A
authors.lastname: Hamilton
authors.affiliation: InVentiv Health Clinical, Wilmington, DE, USA.
authors.forename: Dongmei
authors.initials: D
authors.lastname: Zhai
authors.affiliation: Department of Respiratory Medicine and Allergology, Lund University, Lund, Sweden.
authors.forename: Leif
authors.initials: L
authors.lastname: Bjermer
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D048588:Benzoxazines / Q000008:administration & dosage*; D001993:Bronchodilator Agents / Q000008:administration & dosage; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D000068298:Fluticasone / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D029424:Pulmonary Disease, Chronic Obstructive / Q000175:diagnosis / Q000188:drug therapy / Q000503:physiopathology; D012129:Respiratory Function Tests / Q000379:methods; D000068299:Salmeterol Xinafoate / Q000008:administration & dosage*; D000069447:Tiotropium Bromide / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D048588:Benzoxazines; D001993:Bronchodilator Agents; D004338:Drug Combinations; D000068299:Salmeterol Xinafoate; D000068298:Fluticasone; C549647:olodaterol; D000069447:Tiotropium Bromide
keywords: COPD; FEV1; inhaled corticosteroid; lung function; maintenance treatment; tiotropium