This article is part of Pulmonology Advisor’s coverage of the American Thoracic Society Virtual 2020 meeting.
Patients with chronic obstructive pulmonary disease (COPD) who received a metered dose inhaler (MDI) containing budesonide, glycopyrrolate, and formoterol fumarate showed lung function improvements through 52 weeks compared to glycopyrrolate and formoterol fumarate alone, according to results of a clinical trial sub-study presented virtually at the American Thoracic Society 2020 Virtual meeting, held from August 5-10, 2020.
Researchers conducted the Phase 3 ETHOS trial (ClinicalTrial.gov Identifier: NCT02465567) to assess the efficacy and safety of budesonide/glycopyrrolate/formoterol fumarate MDI at 2 different budesonide doses. In the pulmonary function test sub-study, the researchers assessed lung function at 2 doses of budesonide/glycopyrrolate/formoterol fumarate MDI, glycopyrrolate/formoterol fumarate MDI, and budesonide/formoterol fumarate MDI in a subset of patients.
Spirometry testing results from patients with moderate to very severe COPD were evaluated at baseline and after 24 and 52 weeks following treatment with an MDI containing either budesonide, glycopyrrolate, and formoterol fumarate or glycopyrrolate and formoterol fumarate alone. Both MDI treatments had a high and low dose group. Lung function measurements such as morning pre-dose trough forced expiratory volume in 1 second (FEV1) and FEV1 area under the curve from 0 to 4 hours were then compared between treatment groups.
Of the 3088 patients with moderate to very severe COPD in the modified intent to treat population, both dosing levels of the MDI containing budesonide, glycopyrrolate, and formoterol fumarate significantly improved morning pre-dose trough FEV1 and FEV1 area under the curve from 0 to 4 hours at weeks 24 and 52 (P ≤.0035 for both).
“Both [budesonide, glycopyrrolate, and formoterol fumarate] MDI 320/18/9.6 μg and [budesonide, glycopyrrolate, and formoterol fumarate] MDI 160/18/9.6 μg significantly improved trough FEV1 vs [glycopyrrolate/formoterol fumarate] MDI and FEV1 [area under the curve] 0-4 [hours] vs [budesonide/formoterol fumarate] MDI at Week 24,” the study authors wrote. “The lung function benefits with both doses of [budesonide, glycopyrrolate, and formoterol fumarate] were maintained after 52 weeks of treatment.”
Disclosure: This clinical trial was supported by AstraZeneca. Please see the original reference for a full list of authors’ disclosures.
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Rabe KF, Martinez FJ, Singh D, et al. Improvements in lung function with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) versus dual therapies in patients with COPD: a sub-study of the ETHOS trial. Presented at: American Thoracic Society 2020 Virtual; August 5-10, 2020. Abstract #P1069.