Combination bronchodilator therapy in the management of chronic obstructive pulmonary disease

Respiratory Research

Table 4 LABA and LAMA combinations under investigation: ongoing trials

LAMA	LABA	Trial numbers	Summary of ongoing Phase II/III studies
Aclidinium	Formoterol	NCT01572792, NCT0143797, NCT01462942, NCT01437540, NCT01049360	4 Phase III studies and 1 Phase II study, examining the long-term efficacy and safety of 2 different doses of aclidinium + formoterol vs monotherapy with either component and placebo
Glycopyrrolate	Formoterol	NCT01587079, NCT01587079	2 Phase II studies (both recently completed), examining efficacy of the combination vs the monotherapy components and tiotropium
Glycopyrronium	Indacaterol	NCT01120691 (SPARK), NCT01202188 (GLEAM) (pivotal studies, both completed), NCT0171251, NCT01604278, NCT01727141, NCT01529632, NCT01709903	2 recently completed pivotal Phase III studies investigating efficacy and safety, exacerbations, exercise, and TDI, and 5 ongoing Phase III studies, examining safety and efficacy of combination vs placebo, monotherapy components, and salmeterol/fluticasone
Tiotropium	Olodaterol	NCT01431274, NCT01431287 (pivotal studies), NCT01525615, NCT01533922, NCT01533935, NCT01559116, NCT01536262	7 Phase III studies, investigating efficacy and safety of combination vs monotherapy components and effects on exercise
Umeclidinium (GSK573719)	Vilanterol	NCT01313637, NCT01316900, NCT01316913, NCT01313650 (pivotal studies, recently completed), NCT01716520, NCT01491802	6 Phase III studies (4 recently completed, 2 ongoing), focused primarily on efficacy, with other studies examining AE incidence, exercise endurance time, and exertional dyspnea

ClinicalTrials.gov was searched for Phase II and III trials of fixed-dose combinations of LAMA + LABA. Access date: 12/05/12.
LABA = long-acting β₂-agonist; LAMA = long-acting muscarinic antagonist; AE = adverse event; TDI = Transition Dyspnea Index; FDA = Food and Drug Administration.

ISSN: 1465-993X