Trial reportBMJ (Clinical research ed.)2013
Pneumonia and pneumonia related mortality in patients with COPD treated with fixed combinations of inhaled corticosteroid and long acting β2 agonist: observational matched cohort study (PATHOS).
Trial report in BMJ (Clinical research ed.), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT01146392 (A Retrospective Epidemiological Study to Map Out Patients With Chronic Obstructive Pulmonary Disease), which is not on this map. Cited by 93 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.
A Retrospective Epidemiological Study to Map Out Patients With Chronic Obstructive Pulmonary Disease (COPD) and Describe COPD Health Care in Real-Life Primary Care During the First Ten Years of the 21th Century
Who cites it
93 citing papers in PubMed, 6 syntheses or guidelines pooled it, 177 citations in OpenAlex.
- Intraclass comparison of inhaled corticosteroids for the risk of pneumonia in chronic obstructive pulmonary airway disorder: a network meta-analysis and meta-regression.International journal of clinical pharmacy · 2024Pooled it
- Single-inhaler triple vs single-inhaler dual therapy in patients with chronic obstructive pulmonary disease: a meta-analysis of randomized control trials.Respiratory research · 2021Pooled it
- Systematic review on long-term adverse effects of inhaled corticosteroids in the treatment of COPD.European respiratory review : an official journal of the European Respiratory Society · 2021Pooled it
- Intraclass Difference in Pneumonia Risk with Fluticasone and Budesonide in COPD: A Systematic Review of Evidence from Direct-Comparison Studies.International journal of chronic obstructive pulmonary disease · 2020Pooled it
- Pooled it
- Inhaled steroids and risk of pneumonia for chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2014Pooled it
- The role of FGF-2 in smoke-induced emphysema and the therapeutic potential of recombinant FGF-2 in patients with COPD.Experimental & molecular medicine · 2018Trial
- A 12-week open-label, randomized, controlled trial and 24-week extension to assess the efficacy and safety of fluticasone propionate/formoterol in children with asthma.Therapeutic advances in respiratory disease · 2016Trial
- Comparative effectiveness of budesonide/formoterol combination and fluticasone/salmeterol combination among chronic obstructive pulmonary disease patients new to controller treatment: a US administrative claims database study.Respiratory research · 2015Trial
- Fluticasone- vs Budesonide-Based Dual Therapy for COPD.JAMA network open · 2026Article
- High-risk adverse events in two types of single inhaler triple-therapy: a pharmacovigilance study based on the FAERS database.Frontiers in pharmacology · 2024Article
- Risk of Pneumonia in Patients with COPD Initiating Fixed Dose Inhaled Corticosteroid (ICS) / Long-Acting Bronchodilator (LABD) Formulations Containing Extrafine Beclometasone Dipropionate versus Patients Initiating LABD Without ICS.Pragmatic and observational research · 2024Article
- Article
- Comparison of pneumonia incidence between long-acting muscarinic antagonist and inhaled corticosteroid plus long-acting beta agonist in patients with COPD.Scientific reports · 2023Article
- Inhaled corticosteroids and adverse outcomes among chronic obstructive pulmonary disease patients with community-acquired pneumonia: a population-based cohort study.Frontiers in medicine · 2023Article
- Response to the Letter to the Editor Regarding "Intraclass Difference in Pneumonia Risk with Fluticasone and Budesonide in COPD: A Systematic Review of Evidence from Direct-Comparison Studies" [Response to Letter].International journal of chronic obstructive pulmonary disease · 2021Article
- Inhaled Corticosteroids Use and Risk of Invasive Pneumococcal Disease in a Population-based Study.Annals of the American Thoracic Society · 2020Article
- Article
- Risk of active tuberculosis among COPD patients treated with fixed combinations of long-acting beta2 agonists and inhaled corticosteroids.BMC infectious diseases · 2020Observational
- Article
33 more citing papers are in PubMed but not listed here.
Corrections and comments
- Erratum issued
Authors and funding
8 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo investigate the occurrence of pneumonia and pneumonia related events in patients with chronic obstructive pulmonary disease (COPD) treated with two different fixed combinations of inhaled corticosteroid/long acting β2 agonist.
designObservational retrospective pairwise cohort study matched (1:1) for propensity score.
settingPrimary care medical records data linked to Swedish hospital, drug, and cause of death registry data for years 1999-2009.
participantsPatients with COPD diagnosed by a physician and prescriptions of either budesonide/formoterol or fluticasone/salmeterol.
main outcome measuresYearly pneumonia event rates, admission to hospital related to pneumonia, and mortality.
results9893 patients were eligible for matching (2738 in the fluticasone/salmeterol group; 7155 in the budesonide/formoterol group), yielding two matched cohorts of 2734 patients each. In these patients, 2115 (39%) had at least one recorded episode of pneumonia during the study period, with 2746 episodes recorded during 19,170 patient years of follow up. Compared with budesonide/formoterol, rate of pneumonia and admission to hospital were higher in patients treated with fluticasone/salmeterol: rate ratio 1.73 (95% confidence interval 1.57 to 1.90; P<0.001) and 1.74 (1.56 to 1.94; P<0.001), respectively. The pneumonia event rate per 100 patient years for fluticasone/salmeterol versus budesonide/formoterol was 11.0 (10.4 to 11.8) versus 6.4 (6.0 to 6.9) and the rate of admission to hospital was 7.4 (6.9 to 8.0) versus 4.3 (3.9 to 4.6). The mean duration of admissions related to pneumonia was similar for both groups, but mortality related to pneumonia was higher in the fluticasone/salmeterol group (97 deaths) than in the budesonide/formoterol group (52 deaths) (hazard ratio 1.76, 1.22 to 2.53; P=0.003). All cause mortality did not differ between the treatments (1.08, 0.93 to 1.14; P=0.59).
conclusionsThere is an intra-class difference between fixed combinations of inhaled corticosteroid/long acting β2 agonist with regard to the risk of pneumonia and pneumonia related events in the treatment of patients with COPD.
trial registrationClinical Trials.gov NCT01146392.
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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.