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  • Open Access Icon
  • Research Article
  • 10.15326/jcopdf.2023.0445
Respiratory Microbiome Profiles Associated With Distinct Inflammatory Phenotype and Clinical Indexes in Chronic Obstructive Pulmonary Disease.
  • Jan 1, 2024
  • Chronic Obstructive Pulmonary Diseases Journal of the COPD Foundation
  • Tao Yu + 3 more

Respiratory microbiome studies have fostered our understanding of the various phenotypes and endotypes of heterogeneous chronic obstructive pulmonary disease (COPD). This study aimed to identify microbiome-driven clusters that reflect the clinical features and dominant microbiota of COPD. This cross-sectional study included 32 patients with stable COPD between December 2019 and December 2020 from the outpatient clinic of the China-Japan Friendship Hospital. Sputum samples were tested for 16S rRNA. Patients were classified according to the species level using an unsupervised clustering method to compare the inflammatory phenotypes of 2 clusters and analyze the correlation between the main bacteria and clinical indicators in each cluster. Patients were further divided into 2 clusters according to microorganisms. Neutrophils in cluster 1 were significantly increased compared with cluster 2. Cluster 1 was predominantly Bacteroides, while cluster 2 was dominated by Prevotella and Fusobacterium at the genus level. Fusobacterium was negatively correlated with the COPD Assessment Test (CAT) score, and Bacteroides were positively correlated with the number of acute exacerbations of COPD. This study found that differential flora was negatively associated with CAT scores and the number of acute exacerbations of COPD. This microbiome-driven, unbiased clustering method for COPD can help identify new endotype-related COPD phenotypes.

  • Open Access Icon
  • Research Article
  • Cite Count Icon 2
  • 10.15326/jcopdf.2023.0425
Inhaler Formulary Change in COPD and the Association with Exacerbations, Health Care Utilization, and Costs.
  • Jan 1, 2024
  • Chronic Obstructive Pulmonary Diseases Journal of the COPD Foundation
  • Kevin I Duan + 8 more

Prescription formularies specify which medications are available to patients. Formularies change frequently, potentially forcing patients to switch medications for nonclinical indications (nonmedical switching). Nonmedical switching is known to impact disease control and adherence. The consequences of nonmedical switching have not been rigorously studied in COPD. We conducted a cohort study of Veterans with COPD on inhaler therapy in January 2016 when formoterol was removed from the Department of Veterans Affairs (VA) national formulary. A 2-point difference-in-differences analysis using multivariable negative binomial and generalized linear models was performed to estimate the association of the formulary change with patient outcomes in the 6 months before and after the change. Our primary outcome was the number of COPD exacerbations in 6 months, with secondary outcomes of total health care encounters and encounter-related costs in 6 months. We identified 10,606 Veterans who met our inclusion criteria, of which 409 (3.9%) experienced nonmedical switching off formoterol. We did not identify a change in COPD exacerbations (-0.04 exacerbations; 95% confidence interval [CI] -0.12, 0.03) associated with the formulary change. In secondary outcome analysis, we did not observe a change in the number of health care encounters (-0.12 visits; 95% CI -1.00, 0.77) or encounter-related costs ($369; 95% CI -$1141, $1878). Among COPD patients on single inhaler therapy, nonmedical inhaler switches due to formulary discontinuation of formoterol were not associated with changes in COPD exacerbations, encounters, or encounter-related costs. Additional research is needed to confirm our findings in more severe disease and other settings.

  • Open Access Icon
  • Research Article
  • Cite Count Icon 10
  • 10.15326/jcopdf.2022.0306
The Association Between Systemic Arterial Hypertension and Chronic Obstructive Pulmonary Disease. Results from the U.S. National Health and Nutrition Examination Survey 1999-2018: A Cross-sectional Study.
  • Jan 1, 2023
  • Chronic Obstructive Pulmonary Diseases Journal of the COPD Foundation
  • Xiaopeng Liang + 2 more

Systemic arterial hypertension (HTN) is one of the common comorbidities among patients with chronic obstructive pulmonary disease (COPD). This study aimed to investigate the association between HTN and COPD. A total of 46,804 eligible non-pregnant participants aged ≥ 20 years examined in the Mobile Examination Center of the National Health and Nutrition Examination Survey (NHANES) 1999-2018 were included in this cross-sectional study. Participants with invalid data on covariates, HTN, and COPD were excluded. The association between HTN and COPD was studied using logistic regression upon adjusting the potential covariates. Among the participants, 46.1% (95% confidence interval [CI], 45.3-46.9) had HTN, and 6.8% (95% CI, 6.4-7.2) had self-reported COPD. COPD was associated with HTN (OR [odds ratio]=1.18, 95% CI [1.05-1.31], P<0.01) after adjusting for demographics, socioeconomic factors, smoking, diabetes, body mass index, and medication use, including inhaled corticosteroids and methylxanthines. The association between HTN and COPD was significant among adults younger than 60 years (P<0.01). Stratified by smoking status, there was a significant association between HTN and COPD in current heavy smokers (1.25, 95% CI [1.01-1.58]; P=0.04). In this nationwide survey, COPD was associated with HTN. The association was more robust among adults younger than 60 years and current heavy smokers. Future prospective studies are needed to examine the relationship between HTN and COPD.

  • Open Access Icon
  • Research Article
  • Cite Count Icon 2
  • 10.15326/jcopdf.2023.0417
The Current Landscape of COPD-Related Clinical Trials Registered on the World Health Organization's International Clinical Trials Registry Platform: A Comprehensive Analysis of Study Characteristics and Publication Status.
  • Jan 1, 2023
  • Chronic Obstructive Pulmonary Diseases Journal of the COPD Foundation
  • Meimei Xu + 3 more

Despite studies investigating the publication rates and factors influencing publication outcomes of clinical trials in some disease fields, there is a notable lack of research focusing on chronic obstructive pulmonary disease (COPD) clinical trials. This study aims to explore the characteristics of COPD-related clinical trials and identify factors associated with publication status and publication time. A systematic search was conducted on the World Health Organization International Clinical Trials Registry Platform on April 28, 2022, to identify completed interventional clinical trials related to COPD. Various trial features were analyzed, and factors influencing publication status and time were examined. A total of 2577 completed interventional clinical trials focusing on COPD were identified. A total of 42.76% of trials enrolled ≤50 participants. The majority of trials were randomized (81.72%), blind (57.39%), parallel-assignment (59.14%), single-center (51.30%), multi-arm (83.86%), nonindustry funded (52.00%), and conducted for therapeutic purposes (73.11%). The 2-year cumulative publication rate was found to be 27.9%. The median time of study duration, dissemination lag, and publication lag were 17.27, 21.07, and 24.70 months, respectively. Multivariate analysis revealed that sample size, blind design, and study phase significantly influenced the likelihood of publication, while intervention model, primary purpose, study phase, funder, and study duration were significant factors affecting publication time. The findings highlight the inadequacy of large multi-center interventional clinical trials for COPD and indicate a low 2-year cumulative publication rate. Strengthening collaboration among investigators and adopting scientifically robust designs for larger phase 3 clinical trials are crucial to advancing COPD research and enhancing publication outcomes.

  • Open Access Icon
  • Research Article
  • 10.15326/jcopdf.2023.0387
Randomized Controlled Trials on Chronic Obstructive Pulmonary Disease in Africa: A Systematic Review.
  • Jan 1, 2023
  • Chronic Obstructive Pulmonary Diseases Journal of the COPD Foundation
  • Eric Sven Kroeber + 7 more

The rising burden of chronic obstructive pulmonary disease (COPD) in African countries is attributed to the growing and ageing of the populations, lifestyle, and environmental changes. This systematic review aims to map the available evidence on interventions on COPD in Africa. We performed a systematic search in six (including local African) databases and registries with updates until January 2022. We included randomized controlled trials (RCTs) the included patients diagnosed with COPD that were conducted in Africa, studying outcomes on acute respiratory episodes and rates, physical and functional abilities, and adverse events. We followed the PRISMA guidelines. The study quality was assessed using the Cochrane Risk of Bias tool. We primarily summarized the results in a narrative way. Out of 1594 identified publications we included 18 studies with altogether 1504 participants, conducted in Egypt, South Africa, and Tunisia. Eight studies investigated interventions for patients in stable phases treated in outpatient settings and ten included patients with acute COPD exacerbation treated in emergency or intensive care settings. The interventions mainly include ventilatory support, pharmacological and rehabilitative interventions. Reported treatment effects were heterogeneous ranging from no beneficial effects to clinically relevant benefits. The included studies were conducted in countries with high infrastructural development and half of them were set in intensive care units. Despite the paucity of RCTs on COPD management, research activities have been increasing over the last years.