Targeted Retreatment of Incompletely Recovered Chronic Obstructive Pulmonary Disease Exacerbations with Ciprofloxacin A Double-Blind, Randomized, Placebo-controlled, Multicenter, Phase III Clinical Trial



Ritchie, Andrew I, Brill, Simon E, Vlies, Ben H, Finney, Lydia J, Allinson, James P, Alves-Moreira, Luana, Wiseman, Dexter J, Walker, Paul P ORCID: 0000-0002-5449-9551, Baker, Emma, Elkin, Sarah L
et al (show 5 more authors) (2020) Targeted Retreatment of Incompletely Recovered Chronic Obstructive Pulmonary Disease Exacerbations with Ciprofloxacin A Double-Blind, Randomized, Placebo-controlled, Multicenter, Phase III Clinical Trial. American Journal of Respiratory and Critical Care Medicine, 202 (4). pp. 549-557.

Access the full-text of this item by clicking on the Open Access link.

Abstract

<b>Rationale:</b> Chronic obstructive pulmonary disease (COPD) exacerbations are prone to nonrecovery, but there are no data about the effectiveness of retreatment for these prolonged events. We examined whether further therapy with ciprofloxacin for incompletely resolved COPD exacerbations prolonged the time until the next event.<b>Objectives:</b> To assess whether incompletely recovered COPD exacerbations benefit from additional treatment with ciprofloxacin, at Day 14.<b>Methods:</b> In a multicenter, randomized double-blind placebo-controlled trial, we studied retreatment with oral ciprofloxacin 500 mg or matched placebo twice daily for 7 days in patients with Global Initiative for Chronic Obstructive Lung Disease stage II-IV COPD and persistent symptoms and/or serum C-reactive protein ≥8 mg/L initiated 14 (±3) days after an index COPD exacerbation. The primary outcome was the time to the next exacerbation within a 90-day period.<b>Measurements and Main Results:</b> Among 826 patients screened at four centers, 144 eligible participants with incomplete recovery were randomized to receive ciprofloxacin (<i>n</i> = 72) or placebo (<i>n</i> = 72). Within 90 days of randomization, 57% of the patients in the ciprofloxacin group and 53% in the placebo group experienced one or more exacerbations. The median time to the next exacerbation was 32.5 days (interquartile range 13-50) in the placebo arm and 34 days (interquartile range 17-62) in the ciprofloxacin arm, which was not significantly different (adjusted hazard ratio, 1.07; 95% confidence interval, 0.68-1.68; <i>P</i> = 0.76). No significant differences were seen in quality-of-life scores or lung function between the treatment groups.<b>Conclusions:</b> In patients with persistent symptoms and/or raised C-reactive protein 14 days after a COPD exacerbation, an additional course of ciprofloxacin resulted in no additional benefit compared with placebo. This suggests that nonrecovered exacerbations are not driven by ongoing bacterial infection and may potentially be targeted with antiinflammatory therapy.Clinical trial registered with www.clinicaltrials.gov (NCT02300220).

Item Type: Article
Uncontrolled Keywords: chronic obstructive pulmonary disease, exacerbations, retreatment, ciprofloxacin, incomplete recovery
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Clinical Directorate
Faculty of Health and Life Sciences > Institute of Life Courses and Medical Sciences
Depositing User: Symplectic Admin
Date Deposited: 05 Jul 2021 15:56
Last Modified: 18 Jan 2023 21:36
DOI: 10.1164/rccm.201910-2058OC
Open Access URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC74273...
Related URLs:
URI: https://livrepository.liverpool.ac.uk/id/eprint/3128898