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ObjectivesTo compare mortality risks in patients with rheumatoid arthritis-associated interstitial lung disease (RA-ILD) and patients with RA without ILD.DesignMatched cohort study.SettingThe study was conducted in Denmark, using nationwide, prospectively collected data.ParticipantsAmong patients with RA diagnosed between 2004 and 2016, 679 patients with RA-ILD were matched for birth year, gender and age at RA diagnosis with 11 722 patients with RA but without ILD.Main outcome measuresMortality risks were assessed using Kaplan-Meier mortality curves, and hazard rate ratios (HRRs) for death were estimated using Cox proportional hazards regression models.ResultsThe number of prevalent RA patients more than doubled from 15 352 to 35 362 individuals during the study period. RA-ILD was seen in 2.2% of incident RA patients. 34.0% of RA-ILD cases were diagnosed within 1 year prior to and 1 year after the RA diagnosis. One-year mortality was 13.9% (95% CI, 11.4% to 16.7%) in RA-ILD and 3.8% (95% CI, 3.5% to 4.2%) in non-ILD RA, 5-year mortality was 39.0% (34.4% to 43.5%) and 18.2% (17.3% to 19.1%) and 10-year mortality was 60.1% (52.9% to 66.5%) and 34.5% (32.8% to 36.1%), respectively. The HRRs for death were 2 to 10 times increased for RA-ILD compared with non-ILD RA, irrespective of follow-up period. Stratified analysis showed that the HRR for death was highest in the first months after the diagnosis of RA-ILD was made, especially in patients diagnosed with RA before diagnosis of ILD. HRR was higher in males and in patients without comorbidity as assessed by the Charlson Comorbidity Index.ConclusionsILD is a serious complication in RA, with a significantly increased mortality compared with a large matched cohort of RA comparisons without ILD.

Introduction: Interstitial lung disease (ILD) is a serious extraarticular manifestation of rheumatoid arthritis (RA), but no evidence-based therapy exists. Ongoing studies investigate the role of antifibrotic therapies for progressive fibrosing ILD (PF-ILD), including RA-ILD. The aim of the present study was to investigate the frequency of PF-ILD and the clinical characteristics of RA-ILD in a well-characterised, population-based cohort. Methods: We identified patients with RA-ILD diagnosed and followed at the ILD referral centre in Aarhus, Denmark, from 2004 to 2016. Adjusted hazard rate ratios for death were estimated using Cox regression models. The presence of PF-ILD was assessed using recently proposed definitions of relative forced vital capacity (FVC) decline ≥10%, relative diffusion capacity of the lung for carbon monoxide (DLco) decline ≥15% or worsening symptoms or a worsening radiological appearance accompanied by a ≥5 to <10% FVC decline. Results: We identified 102 patients with RA-ILD, and 52% had PF-ILD. Mean follow-up was 3.8 years and median survival was 7.1 years. Thirty-eight patients died during follow-up, and most deaths were from respiratory causes. Predictors of mortality in a multivariate model were DLco and high titres of IgM rheumatoid factor. Conclusion: PF RA-ILD was common and the associated mortality was high.

We estimated the direct and indirect costs associated with extrapulmonary nontuberculous mycobacteria (ENTM) disease in Denmark during 2005-2017. ENTM disease was associated with substantially higher healthcare costs, lower employment income, and increased public benefits before, around, and after diagnosis. Our findings highlight the substantial socioeconomic burden associated with ENTM disease.

We investigated the usefulness and effectiveness of tele-rehabilitation on exercise capacity in patients with idiopathic pulmonary fibrosis (IPF). A randomized study was carried out, including stable patients with IPF for 3 months of tele-rehabilitation: video and chat consultations with a physiotherapist and workout sessions with a virtual physiotherapist agent (VAPA). Moreover, 6-min walk test distance (6MWTD), forced vital capacity (FVC), diffusion capacity for carbon monoxide (DLCO), 7 days pedometry, Saint George Respiratory Questionnaire for interstitial lung disease, The King’s Brief Interstitial Lung Disease Questionnaire, and General Anxiety Disorder 7 Questionnaire were tested before and after 3 months of tele-rehabilitation, as well as after 3 and 6 months follow-up. Patient satisfaction and adherence were also measured for tele-rehabilitation with VAPA. Twenty-nine patients aged 70.9 ± 8.6 years, male 72.4%, FVC% 83.5 ± 17.7, DLCO% 50.6 ± 13.0, 6MWTD 468.4 ± 14.8 were included. Fifteen patients were randomized to tele-rehabilitation with VAPA and 14 to the control group. Differences in 6MWTD between groups were at baseline (+10 m (p = 0.11)) and after 3 (+39.5 m (p = 0.03)), 6 (+34.3 m (p = 0.02)), and 9 months (+40.5 m (p = 0.15)) follow-up. No difference was observed in pedometry and quality of life. Adherence was above 63%. Patient satisfaction was high. Tele-rehabilitation with VAPA appears to be useful in patients with IPF. Exercise capacity was better at follow up at 3 and 6 months compared with the control group. There was no change in quality of life or pedometry. Adherence and patient satisfaction were all high.

IntroductionCannabis-based medicine may alleviate breathlessness. This study will investigate whether dronabinol, a synthetic form of Δ9-tetrahydrocannabinol (Δ9-THC), reduces breathlessness in patients with severe and very severe chronic obstructive pulmonary disease (sCOPD) compared to placebo.MethodsThis single-centre, randomised, double-blinded, placebo-controlled, crossover trial will enrol 30 patients with sCOPD and persistent breathlessness despite optimal treatment. Patients will be recruited from a pulmonary outpatient clinic in Denmark over 24 months. Eligible patients (aged ≥18 years) will receive either dronabinol or placebo for 4 weeks, followed by a 2-week washout, before crossing over to the other treatment for 4 weeks. Exclusion criteria include ongoing infection, substance abuse and significant comorbidities. Primary outcome is breathing discomfort or unpleasantness measured using the 0–10 Numerical Rating Scale. Secondary outcomes include lung function (forced expiratory volume in one second), hair cortisol concentrations, functional tests, plasma THC blood concentrations and questionnaires assessing breathlessness, activity, quality of life, anxiety and depression. Continuous monitoring of vital signs, activity and sleep will be performed using a Garmin Venu 3 smartwatch. Data will be entered into electronic case report forms and monitored by the Good Clinical Practice (GCP) unit in Odense.DiscussionThis will be the largest randomised, double-blinded, crossover trial to investigate dronabinol in patients with COPD and will provide new knowledge on the efficacy and safety.Ethics and disseminationWritten informed consents will be obtained from study patients. The study has been approved by the Danish Medicines Agency (case number: 2023010659) and the medical research ethics committees (case number: 2301456). It is registered in the European Union Clinical Trials Registry (2024-513593-22-00) and ClinicalTrials.gov (NCT06473701). The trial follows the Declaration of Helsinki II and International Council for Harmonisation-GCP guidelines. Findings will be disseminated in peer-reviewed publications.Trial registration numberThe European Union Clinical Trials Registry (2024-513593-22-00) and ClinicalTrials.gov (NCT06473701).

Background Patients with idiopathic pulmonary fibrosis (IPF) have impaired health-related quality of life (HRQL). To measure HRQL, an IPF-specific version of the St. George’s Respiratory Questionnaire (SGRQ-I) was developed, but not sufficiently validated. This study aimed to assess the validity (i.a. known-groups validity and concurrent validity) and test-retest reliability of SGRQ-I in IPF patients with different disease durations. Methods Patients with IPF were consecutively recruited and completed SGRQ, SGRQ-I, King’s Brief Interstitial Lung Disease questionnaire (K-BILD), University of California, San Diego Shortness of Breath Questionnaire (SOBQ) and Short Form-36 (SF-36) along with pulmonary function tests and a 6-min walk test (6MWT) at baseline. After two weeks, SGRQ-I and Global Rating of Change Scales (GRCS) were completed. Results At baseline and after two weeks, 150 and 134 patients completed the questionnaires, respectively. The internal consistency of SGRQ-I was high (Cronbach’s α = 0.92). Good concurrent validity was demonstrated by high intraclass correlation coefficients (ICC = 0.97), Bland-Altman plots and moderate to strong correlations to K-BILD, SOBQ and SF-36 (r = − 0.46 to 0.80). High ICC (0.92) and a Bland-Altman plot indicated good test-retest reliability. SGRQ-I was good at discriminating between patients with different stages of disease (Δscore > 18.1, effect sizes > 0.10). Validity was similar across groups of different disease duration. Conclusions SGRQ-I proved to be valid at distinguishing between different disease severities, valid compared to other HRQL instruments, applicable across different disease durations and reliable upon repetition. SGRQ-I is a valid option for measuring HRQL in patients with IPF. Trial registration The study was registered at clinicaltrials.org ( NCT02818712 ) on 15 June 2016.

Chronic obstructive pulmonary disease (COPD) affects millions of people worldwide. Obesity is commonly seen concomitantly with COPD. People with COPD have reduced quality of life, reduced physical activity, chronic respiratory symptoms, and may suffer from frequent clinical exacerbations. Liraglutide is a glucagon-like peptide-1 receptor agonist (GLP-1RA) approved for weight loss and treatment of type-2 diabetes mellitus. In addition, liraglutide exerts anti-inflammatory actions by reducing IL-6 and MCP-1 levels. We investigated the effect of liraglutide on pulmonary function in people suffering from obesity and COPD. In this controlled, double-blind trial, 40 people with obesity and COPD from two outpatient clinics were allocated randomly to receive liraglutide (3.0 mg, s.c.) or placebo (s.c.) for 40 weeks. At baseline and after 4, 20, 40, and 44 weeks, participants underwent pulmonary-function tests, 6-min walking test, and replied to a questionnaire regarding the clinical impact of COPD (COPD assessment test (CAT)-score). Compared with placebo, liraglutide use resulted in significant weight loss, increased forced vital capacity (FVC) and carbon monoxide diffusion capacity, and improved CAT-score. We found no significant changes in forced expiratory volume in one second (FEV ), FEV /FVC, or 6-min walking distance. In patients suffering from obesity and COPD, 40 weeks of treatment with liraglutide improved some measures of pulmonary function. Our study suggests that liraglutide at 3.0 mg may be appropriate treatment in patients with obesity and COPD.

Patients with chronic obstructive pulmonary disease (COPD) commonly present with cardiovascular disease (CVD). We investigated the association between COPD exacerbations and major cardiovascular (CV) events in a COPD population with a history of CVD. This population-based and register-based cohort study identified all Danish COPD patients aged ≥40 years who visited a hospital-based, pulmonary outpatient clinic for COPD between 1st January, 2010, and 31st December, 2016, from a nationwide COPD registry. Patients with a history of a major CV event 36‒6 months prior to their COPD measurement date and no CV event 6 months before this date were included. During a 6-month assessment period, the risks of a new CV event (hospitalization with fatal/non-fatal stroke, myocardial infarction, or heart failure) and moderate and severe COPD exacerbations were evaluated. Odds ratios with 95% confidence intervals for CV events and death were estimated using adjusted logistic regression models. Of the 1501 COPD patients included, 55% experienced a COPD exacerbation and 13% experienced both an exacerbation and a CV event during follow-up (6 months). The odds of a CV event were 1.5 times higher in patients with a moderate exacerbation and more than 6-times higher in those with a severe exacerbation vs patients with no exacerbation(s). The majority of CV events occurred within 30 days post exacerbation in patients who experienced both an exacerbation and a CV event. In total, 113 patients died during the study period: 28% of deaths were caused by CVD and 72% by reasons other than CVD, mostly COPD. In patients with known CVD, severe COPD exacerbations are associated with increased odds of major CV events that occur within 30 days post exacerbation, highlighting the need to prevent exacerbations in COPD patients with concomitant CVD to potentially improve both respiratory and CV health.

IntroductionUnderstanding patient perspectives on asthma and chronic obstructive pulmonary disease (COPD) is limited, with no prior studies employing such a large-scale, proactive survey to systematically target individuals with a confirmed prescription for inhalation medication. This study aims to explore how patients with asthma or COPD manage their lives, including treatment experiences, symptoms and impacts on daily life.Methods and analysisA nationwide survey will be launched in January 2025, targeting adults (≥18 years) in Denmark diagnosed with asthma or COPD and prescribed or dispensed inhalation medication between 1 October 2023 and 30 September 2024. Data from the Danish Health Data Authority’s Register of Medicinal Product Statistics will identify eligible individuals. The electronic survey will be distributed via e-Boks to approximately 450 000 individuals.The questionnaire integrates validated tools—COPD Assessment Test, Modified Medical Research Council scale, EuroQol 5-Dimension 5-Level and Asthma Control Test—alongside expert-developed questions on symptoms, diagnosis, disease control, treatment and patient experiences. Questionnaire development included 10 cognitive interviews with patients from the Outpatient Clinic at Vejle Hospital.Descriptive statistics will be used to analyse both continuous and categorical data, with sensitivity analyses conducted as well. Data management will be handled in Research Electronic Data Capture, and statistical analyses will be performed using Stata V.18.0.Ethics and disseminationThe study is registered with the Danish Data Protection Agency (24/5229) and Open Patient Data Explorative Network (OP_2094) and follows the Declaration of Helsinki. Results will be published in peer-reviewed journals, presented at national and international conferences and shared through patient associations.

Background Patients suffering from fibrotic interstitial lung diseases (fILD) have a poor prognosis and a high symptom burden. Palliative treatment includes relief of symptoms such as breathlessness. There is no evidence-based treatment for chronic breathlessness but opioids are often used despite concerns due to the hypothetical risk of respiratory depression. This study investigated the effect of oral morphine drops in patients with fILD on chronic breathlessness and safety. Methods In a double-blinded placebo-controlled study, 36 patients with fILD were randomised to either four daily doses of 5 mg of oral morphine drops or placebo for 1 week. Endpoints and safety parameters were obtained at baseline, at follow-up after 1 h and 1 week. Results The primary endpoint, the visual analogue score (VAS) of dyspnea was reduced by 1.1 ± 0.33 cm in the morphine group at follow-up compared to baseline ( P  < 0.01), whereas the reduction was 0.35 ± 0.47 cm in the placebo group. However, the difference between the two groups was not statistically significant ( p  = 0.2). Oral morphine drops did not affect respiratory frequency, pulse rate, blood pressure, peripheral saturation or the 6-min walk test. More patients treated with morphine reported constipation, nausea and confusion. Conclusion Oral administration of morphine drops, 20 mg a day, in patients with fILD did not significantly reduce dyspnea VAS score during 1 week compared to placebo. Oral morphine did not induce respiratory depression, but was related to an increased risk of constipation, nausea and confusion. Trial registration The trial is registered in clinicaltrials.gov (Identifier: NCT02622022 ). Registered 4 December 2015.