After careful consideration, the American Thoracic Society canceled its annual meeting that was to take place in Philadelphia, Pennsylvania from May 15-20, because of the ongoing coronavirus disease 2019 (COVID-19) pandemic. Although the live events will not proceed as planned, our readers can still find coverage of research that was scheduled to be presented at the meeting. A virtual event is being planned for later this year.
In patients with chronic obstructive pulmonary disease (COPD), treatment with single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) resulted in more health status improvements and greater lung function benefit compared with multiple-inhaler triple therapy (MITT) with inhaled corticosteroid + long-acting muscarinic antagonist + long-acting beta-agonist (ICS+LAMA+LABA) combination therapy, according to findings intended to be presented at the American Thoracic Society (ATS) International Conference. (Select research is slated to be presented in a virtual format later this year.)
In patients with COPD, use of multiple inhalers is associated with more errors and worse adherence than single-inhaler regimens. However, real-world effectiveness data on the health status of patients using single-inhaler vs multiple-inhaler regimens are lacking. Therefore, researchers conducted a randomized, open-label, phase 4 effective study (INTREPID; ClinicalTrials.gov Identifier: NCT03467425) to evaluate the effect of a single-inhaler FF/UMEC/VI triple therapy compared with a MITT using ICS+LAMA+LABA on health status, measured with the COPD Assessment Test (CAT), over 24 weeks in 5 European countries. The primary end point was the proportion of CAT responders (≥2 unit decrease in CAT score from baseline at week 24).
The intent-to-treat population totaled 3092 patients (FF/UMEC/VI, n=1545; MITT, n=1547). The researchers found that the odds of being a CAT responder at week 24 were statistically significantly greater with FF/UMEC/VI than with MITT (odds ratio, 1.31; P <.001). At week 24, FF/UMEC/VI improved the forced expiratory volume in 1 second (FEV1) change from baseline by 50 mL more than MITT (P <.001). In total, 38 of the 653 (6%) patients treated with FF/UMEC/VI patients and 7 of the 230 (3%) patients treated with MITT made 1 or more critical errors in inhalation technique at week 24 (P =.103).
In addition, safety profiles were similar between the cohorts, with no new safety findings. Of note, treatment pneumonia serious adverse events occurred in 26 (2%) and 30 (2%) patients in the FF/UMEC/VI and MITT cohorts, respectively.
The researchers concluded, “In usual clinical care, treatment with single-inhaler FF/UMEC/VI results in significantly more patients with health status improvements, and greater lung function benefit, vs MITT, with similar safety profiles.”
Disclosure: This clinical trial was supported by GlaxoSmithKline. Please see the original reference for a full list of authors’ disclosures.
Halpin DM, Worsley S, Ismaila AS, et al. Intrepid: Clinical effectiveness of once-daily single-inhaler fluticasone furoate/umeclidinium/vilanterol versus multiple-inhaler triple therapy in usual clinical practice. Am J Respir Crit Care Med. 2020;201:A4313.