RATIONALE: Antimicrobial therapy remains a controversial issue in nonsevere exacerbations of chronic obstructive pulmonary disease (COPD). OBJECTIVES: To evaluate the efficacy of antibiotic therapy in moderate exacerbations of mild-to-moderate COPD. METHODS: This study involved a multicenter, parallel, double-blind, placebo-controlled, randomized clinical trial. Patients aged 40 years or older, smokers, or ex-smokers of 10 pack-years or more with spirometrically confirmed mild-to-moderate COPD (FEV(1) > 50% predicted and FEV(1)/FVC ratio < 0.7) and diagnosed with an exacerbation were enrolled in the study. The patients were randomized to receive amoxicillin/clavulanate 500/125 mg three times a day or placebo three times a day for 8 days. MEASUREMENTS AND MAIN RESULTS: The primary outcome measure was clinical cure at end of therapy visit (EOT) at Days 9 to 11. A total of 310 subjects fulfilled all the criteria for efficacy analysis. A total of 117 patients with amoxicillin/clavulanate (74.1%) and 91 withplacebo (59.9%) were considered cured at EOT (difference, 14.2%; 95% confidence interval, 3.7-24.3). The median time to the next exacerbation was significantly longer in patients receiving antibiotic compared with placebo (233 d [interquartile range, 110-365] compared with 160 d [interquartile range, 66-365]; P < 0.05). The best C-reactive protein serum cut-off for predicting clinical failure with placebo was 40 mg/L, with an area under the curve of 0.732 (95% confidence interval, 0.614-0.851). CONCLUSIONS: Treatment of ambulatory exacerbations of mild-to-moderate COPD with amoxicillin/clavulanate is more effective and significantly prolongs the time to the next exacerbation compared with placebo.
RCT Entities:
RATIONALE: Antimicrobial therapy remains a controversial issue in nonsevere exacerbations of chronic obstructive pulmonary disease (COPD). OBJECTIVES: To evaluate the efficacy of antibiotic therapy in moderate exacerbations of mild-to-moderate COPD. METHODS: This study involved a multicenter, parallel, double-blind, placebo-controlled, randomized clinical trial. Patients aged 40 years or older, smokers, or ex-smokers of 10 pack-years or more with spirometrically confirmed mild-to-moderate COPD (FEV(1) > 50% predicted and FEV(1)/FVC ratio < 0.7) and diagnosed with an exacerbation were enrolled in the study. The patients were randomized to receive amoxicillin/clavulanate 500/125 mg three times a day or placebo three times a day for 8 days. MEASUREMENTS AND MAIN RESULTS: The primary outcome measure was clinical cure at end of therapy visit (EOT) at Days 9 to 11. A total of 310 subjects fulfilled all the criteria for efficacy analysis. A total of 117 patients with amoxicillin/clavulanate (74.1%) and 91 with placebo (59.9%) were considered cured at EOT (difference, 14.2%; 95% confidence interval, 3.7-24.3). The median time to the next exacerbation was significantly longer in patients receiving antibiotic compared with placebo (233 d [interquartile range, 110-365] compared with 160 d [interquartile range, 66-365]; P < 0.05). The best C-reactive protein serum cut-off for predicting clinical failure with placebo was 40 mg/L, with an area under the curve of 0.732 (95% confidence interval, 0.614-0.851). CONCLUSIONS: Treatment of ambulatory exacerbations of mild-to-moderate COPD with amoxicillin/clavulanate is more effective and significantly prolongs the time to the next exacerbation compared with placebo.
Authors: Aureliano Paolo Finch; Patricia van Velzen; Gerben Ter Riet; Peter J Sterk; Jan M Prins; Judith E Bosmans Journal: Pharmacoeconomics Date: 2019-05 Impact factor: 4.981
Authors: David Gillespie; Christopher C Butler; Janine Bates; Kerenza Hood; Hasse Melbye; Rhiannon Phillips; Helen Stanton; Mohammed Fasihul Alam; Jochen Wl Cals; Ann Cochrane; Nigel Kirby; Carl Llor; Rachel Lowe; Gurudutt Naik; Evgenia Riga; Bernadette Sewell; Emma Thomas-Jones; Patrick White; Nick A Francis Journal: Br J Gen Pract Date: 2021-03-26 Impact factor: 5.386
Authors: Dheeraj Gupta; Ritesh Agarwal; Ashutosh Nath Aggarwal; V N Maturu; Sahajal Dhooria; K T Prasad; Inderpaul S Sehgal; Lakshmikant B Yenge; Aditya Jindal; Navneet Singh; A G Ghoshal; G C Khilnani; J K Samaria; S N Gaur; D Behera Journal: Lung India Date: 2013-07
Authors: Nick A Francis; David Gillespie; Patrick White; Janine Bates; Rachel Lowe; Bernadette Sewell; Rhiannon Phillips; Helen Stanton; Nigel Kirby; Mandy Wootton; Emma Thomas-Jones; Kerenza Hood; Carl Llor; Jochen Cals; Hasse Melbye; Gurudutt Naik; Micaela Gal; Deborah Fitzsimmons; Mohammed Fasihul Alam; Evgenia Riga; Ann Cochrane; Christopher C Butler Journal: Health Technol Assess Date: 2020-03 Impact factor: 4.014