Trial reportJournal of negative results in biomedicine2015
A double-blind, randomised, placebo-controlled study of roxithromycin and doxycycline combination, roxithromycin alone, or matching placebo for 12 weeks in adults with frequent exacerbations of chronic obstructive pulmonary disease.
Trial report in Journal of negative results in biomedicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 6 syntheses or guidelines pooled it, 18 citations in OpenAlex.
- Prophylactic antibiotics for adults with chronic obstructive pulmonary disease: a network meta-analysis.The Cochrane database of systematic reviews · 2021Pooled it
- Head-to-head oral prophylactic antibiotic therapy for chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2019Pooled it
- Adverse events in people taking macrolide antibiotics versus placebo for any indication.The Cochrane database of systematic reviews · 2019Pooled it
- Effects of long-term macrolide therapy at low doses in stable COPD.International journal of chronic obstructive pulmonary disease · 2019Pooled it
- Prophylactic antibiotic therapy for chronic obstructive pulmonary disease (COPD).The Cochrane database of systematic reviews · 2018Pooled it
- Long-term macrolide treatment for the prevention of acute exacerbations in COPD: a systematic review and meta-analysis.International journal of chronic obstructive pulmonary diseasePooled it
- Social determinants of health in clinical trials examining long-term oral antibiotics in COPD: a systematic review.ERJ open research · 2026Review
- Efficacy of Prophylactic Antibiotics in COPD: A Systematic Review.Antibiotics (Basel, Switzerland) · 2024Review
- Revisiting the Use of Antibiotics to Prevent COPD Exacerbation: Is Doxycycline the Answer?American journal of respiratory and critical care medicine · 2023Article
- Inhaled Antibiotics and Airway Bacterial Decolonization for Patients with Chronic Obstructive Pulmonary Disease: The Rationale and Future.Journal of translational internal medicine · 2022Article
- Antimicrobial therapies for prevention of recurrent acute exacerbations of COPD (AECOPD): beyond the guidelines.Respiratory research · 2022Review
- The Saudi Thoracic Society Evidence-based guidelines for the diagnosis and management of chronic obstructive pulmonary disease.Annals of thoracic medicineArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAzithromycin prophylaxis has been shown to reduce COPD exacerbations but there is poor evidence for other antibiotics. We compared exacerbation rates in COPD patients with a history of frequent exacerbations (at least three moderate or severe COPD exacerbations in the past two years) during a 12-week treatment course and over a subsequent 48-week follow up period.
results292 patients were randomised to one of three treatments for 12 weeks: roxithromycin 300 mg daily and doxycycline 100 mg daily (n = 101); roxithromycin 300 mg daily (n = 97); or matching placebos (n = 94). There were no differences in the annualised moderate and severe exacerbation rates after treatment with roxithromycin/doxycycline (2.83 (95 % CI 2.37-3.40)) or roxithromycin only (2.69 (2.26-3.21)) compared to placebo (2.5 (2.08-3.03)) (p = 0.352 and p = 0.5832 respectively). Furthermore, there were no differences in the annualised exacerbation rates during 12-week treatment with roxithromycin/doxycycline (1.64 (95 % CI 1.17-2.30)), roxithromycin only (1.75 (1.24-2.41)) or placebo (2.23 (1.68-3.03)) (p = 0.1709 and p = 0.2545 respectively). There were also no significant differences between groups for spirometry or quality of life scores over either the 12-week treatment or 48-week post-treatment periods. Both active treatments were associated with nausea but otherwise adverse events were comparable among treatment groups.
conclusionsTwelve-weeks of prophylaxis with roxithromycin/doxycycline combination or roxithromycin alone did not reduce COPD exacerbations in patients with history of frequent exacerbations. These findings do not support the use of these antibiotics to prevent exacerbations in COPD patients.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.