Concomitant treatment with nebulized formoterol and tiotropium in subjects with COPD: A placebo-controlled trial

SummaryAdding a long-acting β2-agonist (LABA) by dry powder inhaler (DPI) to tiotropium provides significantly increased and sustained bronchodilation in chronic obstructive pulmonary disease (COPD) patients over either product alone. To demonstrate similar benefits with a nebulized LABA, a placebo-controlled trial was conducted to evaluate the efficacy and safety of formoterol fumarate inhalation solution in subjects receiving tiotropium as a maintenance treatment for COPD.After a 7–14-day screening period using tiotropium 18μg once daily, subjects with diagnosed COPD (⩾25% to <65% predicted FEV1) were randomized to receive 20μg formoterol fumarate inhalation solution twice daily for nebulization plus tiotropium (FFIS/TIO) or nebulized placebo twice daily plus tiotropium (PLA/TIO) for 6 weeks. Efficacy was assessed with spirometry at each visit (Day 1, Week 1, 3, 6), the transition dyspnea index (TDI), and St. George's Respiratory Questionnaire (SGRQ).Baseline characteristics were comparable, including mean FEV1% predicted. At Week 6, FEV1 AUC0–3 was 1.52L for FFIS/TIO-treated subjects vs. 1.34L for PLA/TIO-treated subjects (p