In patients with chronic obstructive pulmonary disease (COPD), treatment with the glycopyrrolate/formoterol (GFF) combination is noninferior to treatment with tiotropium/formoterol (TFF), and both combinations have a similar safety profile and good tolerability. These were among study results recently published in Contemporary Clinical Trials Communications.

It has been hypothesized that glycopyrronium, a once-daily long-acting muscarinic antagonists (LAMA), has fewer side effects than tiotropium, which is “often called the gold standard” LAMA for long-term COPD management, said study authors. Recognizing that a dearth of studies exist that directly compare combination therapy with GFF and TFF in patients with COPD, the researchers sought to evaluate and compare the effectiveness of these 2 treatments.

A randomized, prospective, pilot, open-label, parallel-arm study was conducted at a tertiary care hospital in the Chengalpattu district, Tamil Nadu, India, for 12 weeks. The primary study outcome was to demonstrate the noninferiority between the 2 therapies with respect to improvement in forced expiratory volume in 1 second (FEV1) at the end of a 12-week treatment period. The secondary study outcome was an improvement in FEV1/forced vital capacity (FVC) ratio and health status. The FEV1/FVC ratio was evaluated with the use of spirometry at baseline, week 4, week 8, and week 12. Health status was assessed via use of St. George’s Respiratory Questionnaire (SGRQ).


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A total of 60 patients with moderate to severe COPD were randomized in a 1:1 ratio to the GFF group (n=30) or to the TFF group (n=30). Of the 60 study participants, 58 completed the study.

Study authors found that at week 12, the mean FEV1 value was 1.49±0.38 in the GFF arm vs 1.38±0.30 in the TFF arm (P <.01). Further, the FEV1/FVC ratio at 12 weeks was 0.67±0.09 vs 0.75±0.08, respectively (P <.01). In both groups, a significant difference was seen in the mean FEV1 value and the FEV1/FVC ratio, compared with baseline, vs the last follow-up in both groups (P <.01).

Following treatment, health status assessment per SGRQ demonstrated significant improvement in both groups. The incidence of adverse drug reactions was more common in the TFF arm compared with the GFF arm. The adverse events reported most often with TFF included dry mouth, constipation, and frequent urination/urinary retention.

Limitations of the current study included its small sample size, since it was a pilot study. The short study duration was a limiting factor as well. Additionally, the open-label design of the study might have led to selection bias.

The researchers concluded that based on the fact that treatment with GFF is associated with better tolerability than TFF, this combination therapy can be safely recommended for the long-term maintenance of patients with COPD.

Reference  

Jayanthi N, Krishnan K, Sudhir M, Girija S, P AN, Kumar JS. Comparative study on the effectiveness of glycopyrrolate/formoterol versus tiotropium/formoterol in patients with chronic obstructive pulmonary disease. Contemp Clin Trials Commun. Published online May 27, 2022. doi:10.1016/j.conctc.2022.100931