Frequent productive cough in COPD relates to exacerbation risk and treatment benefit from budesonide/glycopyrrolate/formoterol fumarate: a post hoc analysis of KRONOS.
Abstract
BACKGROUND: Frequent productive cough (FPC) is associated with increased exacerbation risk in chronic obstructive pulmonary disease (COPD). These post hoc analyses examined COPD exacerbations in participants without a recent exacerbation history by baseline FPC status (defined as COPD Assessment Test [CAT] subscores ≥2 for both cough and sputum) and for budesonide/glycopyrrolate/formoterol fumarate (BGF) versus dual therapies.
METHODS: KRONOS (NCT02497001) was a 24-week, double-blind, parallel-group, multi-center, Phase III, randomized study in symptomatic people with moderate-to-very severe COPD; COPD exacerbation in the preceding 12 months was not required. Participants were randomized 2:2:1:1 to receive BGF 320/18/9.6 μg, glycopyrrolate/formoterol fumarate (GFF) 18/9.6 μg, budesonide/formoterol fumarate (BFF) 320/9.6 μg via metered-dose inhaler, or open-label budesonide/formoterol fumarate 400/12 μg via dry-powder inhaler (BUD/FORM), as two inhalations twice-daily.
RESULTS: Of 1411 participants in the modified intent-to-treat population without a recent COPD exacerbation history, 965 (68.4 %) had baseline FPC. Moderate/severe exacerbation rates were higher in those with versus without FPC (BGF, 0.47 vs 0.29; BFF, 0.45 vs 0.37; BUD/FORM, 0.67 vs 0.14), except for GFF (0.79 vs 0.83). BGF was associated with reduced moderate/severe exacerbation rates among those with FPC (41 % reduction) and without FPC (65 % reduction) at baseline versus GFF, with similar findings observed…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 1,411 participants or records.
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