Efficacy and tolerability of LABA/LAMA fixed-dose combinations Aclidinium/Formoterol, Glycopyrronium/Indacaterol and Umeclidinium/Vilanterol in the treatment of COPD in daily practice – results of the non-interventional DETECT study

LABA (Long Acting Beta2-Agonists) and/or LAMA (Long Acting Muscarinic Antagonists) represent first treatment options for patients with symptomatic COPD. Although they display different mechanisms of activity, in combination they have a stronger bronchodilating effect than monotherapy so that they are particularly recommended in patients whose symptoms could not be improved sufficiently by a single active ingredient.

Objective of the DETECT-study was to investigate the impact of the approved LABA/LAMA fixed-dose combinations (FDCs) Aclidinium/Formoterol (AC/FT, b. i. d.), Glycopyrronium/Indacaterol (GLY/IND, q. d.) and Umeclidinium/Vilanterol (UME/VL, q. d.) in patients with COPD in daily clinical practice. Therefore, a prospective, non-randomized, 12-month, observational study was implemented to assess the effectiveness of these treatments in COPD patients who had been switched to FDC within the last three months or for whom such a changeover was intended. Changes in lung function were analyzed by documentation of the Forced Expiratory Volume (FEV1) and Forced Vital Capacity (FVC). Quality of life and well-being were evaluated by the COPD Assessment Test (CAT^™). Furthermore, number of exacerbations and early morning COPD symptoms were documented.

In total, 3,653 patients were enrolled by 254 practices of pneumologists, internists, and general practitioners: AC/FT, 2,121 patients; GLY/IND, 1,056; UME/VL, 476. There was no difference in baseline characteristics between treatment groups. After 15 months of FDC-therapy, FEV1 and FVC values significantly improved during the observational time with AC/FT (increase by 0.09 and 0.10 L, respectively), GLY/IND (0.06/0.05 L) and UME/VL (0.12/0.10 L). CAT-scores decreased indicating improved COPD-severity (AC/FT, −4.17; GLY/IND, −3.66; UME/VL, −4.06). Moreover, number of exacerbations as well as early morning COPD symptoms similarly diminished in all treatment groups. A comparable proportion of patients with adverse drug reactions was noticed: AC/FT, 4.07% of patients; GLY/IND, 3.52%; UME/VL, 3.64%.

In summary, AC/FT, GLY/IND and UME/VL provided clinical benefits in lung function, COPD symptoms and risk of exacerbations in a broad cohort of COPD-patients under routine medical practice conditions. All three treatments were well tolerated.