Patients with chronic obstructive pulmonary disease (COPD) treated with a metered dose inhaler containing glycopyrrolate and formoterol fumarate had improved lung function and reduced risk for exacerbations compared with other treatments, according to study results published in Respiratory Research.

Researchers conducted a prespecified pool analysis of several PINNACLE trials (PINNACLE-1, ClinicalTrials.gov Identifier: NC01854645; PINNACLE-2, ClinicalTrials.gov Identifier: NCT01854658; PINNACLE-4, and ClinicalTrials.gov Identifier: NCT0234358). Forced expiratory volume in 1 second (FEV1) measurements from patients with moderate to very severe COPD was compared between groups who had received either metered dose inhaler treatments of glycopyrrolate and formoterol fumarate together, glycopyrrolate alone, formoterol fumarate alone, or placebo twice daily for 24 weeks. Secondary end points included exacerbation risk, clinically important deterioration, and adverse events.

Of the 4983 patients with moderate to very severe COPD, 61.9% had a COPD assessment test (CAT) score ≥15, and 25.0% had experienced ≥1 moderate or severe exacerbation in the past year. After 24 weeks of treatment, the metered dose inhaler combination of glycopyrrolate and formoterol fumarate improved morning pre-dose trough FEV1 compared with glycopyrrolate alone, formoterol fumarate alone, and placebo. Furthermore, the risk for a moderate to severe exacerbation decreased by 18%, 15%, and 28%compared to glycopyrrolate alone, formoterol fumarate alone, and placebo, respectively. The risk of clinically important deterioration also decreased by ≥17% compared with the other treatments.

The study authors wrote, “Pooled analyses of lung function endpoints (pre-dose trough FEV1 and peak FEV1) from the PINNACLE studies supported the findings from the individual studies, with [glycopyrrolate and formoterol fumarate metered dose inhaler] 18/9.6 μg demonstrating significant, clinically meaningful improvements vs placebo and monocomponents in patients with moderate to very severe COPD.”


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Disclosure: The PINNACLE studies were supported by AstraZeneca. Please see the original reference for a full list of authors’ disclosures.

Reference

Martinez FJ, Lipworth BJ, Rabe KF, et al. Benefits of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in improving lung function and reducing exacerbations in patients with moderate-to-very severe COPD: a pooled analysis of the PINNACLE studies [published online May 25, 2020]. Respir Res. doi:10.1186/s12931-020-01388-y