Patient-Reported Outcome Measures in Atopic Dermatitis and Chronic Urticaria Are Underused in Clinical Practice.

BACKGROUND: Patient-reported outcome measures (PROMs) are validated and standardized tools that complement physician evaluations and guide treatment decisions. They are crucial for monitoring atopic dermatitis (AD) and chronic urticaria (CU) in clinical practice, but there are unmet needs and knowledge gaps regarding their use in clinical practice. OBJECCTIVE: We investigated the global real-world use of AD and CU PROMs in allergology and dermatology clinics as well as their associated local and regional networks. METHODS: Across 72 specialized allergy and dermatology centers and their local and regional networks, 2,534 physicians in 73 countries completed a 53-item questionnaire on the use of PROMs for AD and CU. RESULTS: Of 2,534 physicians, 1,308 were aware of PROMs. Of these, 14% and 15% used PROMs for AD and CU, respectively. Half of physicians who use PROMs do so only rarely or sometimes. Use of AD and CU PROM is associated with being female, younger, and a dermatologist. The Patient-Oriented Scoring Atopic Dermatitis Index and Urticaria Activity Score were the most common PROMs for AD and CU, respectively. Monitoring disease control and activity are the main drivers of the use of PROMs. Time constraints were the primary obstacle to using PROMs, followed by the impression that patients dislike PROMs. Users of AD and CU PROM would like training in selecting the proper PROM. CONCLUSIONS: Although PROMs offer several benefits, their use in routine practice is suboptimal, and physicians perceive barriers to their use. It is essential to attain higher levels of PROM implementation in accordance with national and international standards.

Core Outcome Set for IgE-mediated food allergy clinical trials and observational studies of interventions: International Delphi consensus study 'COMFA'.

BACKGROUND: IgE-mediated food allergy (FA) is a global health concern with substantial individual and societal implications. While diverse intervention strategies have been researched, inconsistencies in reported outcomes limit evaluations of FA treatments. To streamline evaluations and promote consistent reporting, the Core Outcome Measures for Food Allergy (COMFA) initiative aimed to establish a Core Outcome Set (COS) for FA clinical trials and observational studies of interventions. METHODS: The project involved a review of published clinical trials, trial protocols and qualitative literature. Outcomes found as a result of review were categorized and classified, informing a two-round online-modified Delphi process followed by hybrid consensus meeting to finalize the COS. RESULTS: The literature review, taxonomy mapping and iterative discussions with diverse COMFA group yielded an initial list of 39 outcomes. The iterative online and in-person meetings reduced the list to 13 outcomes for voting in the formal Delphi process. One more outcome was added based on participant suggestions after the first Delphi round. A total of 778 participants from 52 countries participated, with 442 participating in both Delphi rounds. No outcome met a priori criteria for inclusion, and one was excluded as a result of the Delphi. Thirteen outcomes were brought to the hybrid consensus meeting as a result of Delphi and two outcomes, 'allergic symptoms' and 'quality of life' achieved consensus for inclusion as 'core' outcomes. CONCLUSION: In addition to the mandatory reporting of adverse events for FA clinical trials or observational studies of interventions, allergic symptoms and quality of life should be measured as core outcomes. Future work by COMFA will define how best to measure these core outcomes.

Recognition of COVID-19 with occupational origin: a comparison between European countries.

OBJECTIVES: This study aims to present an overview of the formal recognition of COVID-19 as occupational disease (OD) or injury (OI) across Europe. METHODS: A COVID-19 questionnaire was designed by a task group within COST-funded OMEGA-NET and sent to occupational health experts of 37 countries in WHO European region, with a last update in April 2022. RESULTS: The questionnaire was filled out by experts from 35 countries. There are large differences between national systems regarding the recognition of OD and OI: 40% of countries have a list system, 57% a mixed system and one country an open system. In most countries, COVID-19 can be recognised as an OD (57%). In four countries, COVID-19 can be recognised as OI (11%) and in seven countries as either OD or OI (20%). In two countries, there is no recognition possible to date. Thirty-two countries (91%) recognise COVID-19 as OD/OI among healthcare workers. Working in certain jobs is considered proof of occupational exposure in 25 countries, contact with a colleague with confirmed infection in 19 countries, and contact with clients with confirmed infection in 21 countries. In most countries (57%), a positive PCR test is considered proof of disease. The three most common compensation benefits for COVID-19 as OI/OD are disability pension, treatment and rehabilitation. Long COVID is included in 26 countries. CONCLUSIONS: COVID-19 can be recognised as OD or OI in 94% of the European countries completing this survey, across different social security and embedded occupational health systems.

Associations of burnout with job demands/resources during the pandemic in health workers from Southeast European countries.

Introduction: Despite several studies assessing job demands and burnout in countries from the Southeast European (SEE) region, there is still a lack of data about the psychological impact of the pandemic on health workers (HWs). Aims: The present study aimed to demonstrate and compare levels of burnout dimensions in HWs from SEE countries and to reveal the burnout-job demands/resources relationships in these workers during the pandemic. Materials and methods: During the autumn of 2020, this online multicentric cross-sectional survey studied a large group (N = 4.621) of HWs working in SEE countries. The Maslach Burnout Inventory was used for the measurement of burnout dimensions. We analyzed the job demands by using the Hospital Experience Scale. Remuneration and relationships with superiors were measured using the Questionnaire sur les Ressources et Contraintes Professionnelles (English version). Results: A series of ANOVA comparisons of means revealed the countries in which respondents showed higher mean values of emotional exhaustion (Bosnia and Herzegovina, Bulgaria, Croatia, Moldova, Montenegro, and North Macedonia) and the countries in which respondents showed lower mean values of this burnout dimension (Israel and Romania) (Welch F = 17.98, p < 0.001). We also found differences among HWs from different countries in job demands and job resources. The testing of hierarchical regression models, which have been controlled for certain confounding factors, clearly revealed that emotional exhaustion was predicted by job demands (R2 = 0.37) and job resources (R2 = 0.16). Conclusion: Preventive measures for the improvement of mental health in HWs during the pandemic and beyond have to take into account the differences between countries regarding the country context and current scientific knowledge. A modified stress test should be implemented in hospitals regarding future shocks that might include new pandemics, terrorism, catastrophes, or border conflicts.

Determinants of Burnout among Teachers: A Systematic Review of Longitudinal Studies.

We aimed to review the determinants of burnout onset in teachers. The study was conducted according to the PROSPERO protocol CRD42018105901, with a focus on teachers. We performed a literature search from 1990 to 2021 in three databases: MEDLINE, PsycINFO, and Embase. We included longitudinal studies assessing burnout as a dependent variable, with a sample of at least 50 teachers. We summarized studies by the types of determinant and used the MEVORECH tool for a risk of bias assessment (RBA). The quantitative synthesis focused on emotional exhaustion. We standardized the reported regression coefficients and their standard errors and plotted them using R software to distinguish between detrimental and protective determinants. A qualitative analysis of the included studies (n = 33) identified 61 burnout determinants. The RBA showed that most studies had external and internal validity issues. Most studies implemented two waves (W) of data collection with 6-12 months between W1 and W2. Four types of determinants were summarized quantitatively, namely support, conflict, organizational context, and individual characteristics, based on six studies. This systematic review identified detrimental determinants of teacher exhaustion, including job satisfaction, work climate or pressure, teacher self-efficacy, neuroticism, perceived collective exhaustion, and classroom disruption. We recommend that authors consider using harmonized methods and protocols such as those developed in OMEGA-NET and other research consortia.

Occupational Asthma: The Knowledge Needs for a Better Management.

The management of occupational asthma (OA) may be influenced by several factors and removal from exposure is the main tertiary prevention approach, but it is not always feasible without personal and socioeconomic consequences. Reducing the delay between the onset of suggestive symptoms of OA and the diagnosis of OA is associated with a better prognosis. Workers' education to increase awareness to trigger agents and a medical surveillance program directed especially at at-risk workers could be helpful in reducing this latency time. An early identification of workers who develop rhinitis and conjunctivitis which often precede the onset of asthma symptoms could be important for an early identification of OA. This is particularly important for cases of asthma caused by high-molecular-weight sensitizers and in the early years of employment. The availability of financial support and compensation measures for workers with OA may influence the latency time before diagnosis and, consequently, may influence the OA outcomes. In conclusion, there is a need for high-quality cohort studies that will increase knowledge about risk factor that may influence the timing of diagnosis of OA. This knowledge will be useful for implementation of future surveillance and screening programs in workplaces.

Predictors of Occupational Burnout: A Systematic Review.

We aimed to review occupational burnout predictors, considering their type, effect size and role (protective versus harmful), and the overall evidence of their importance. MEDLINE, PsycINFO, and Embase were searched from January 1990 to August 2018 for longitudinal studies examining any predictor of occupational burnout among workers. We arranged predictors in four families and 13 subfamilies of homogenous constructs. The plots of z-scores per predictor type enabled graphical discrimination of the effects. The vote-counting and binomial test enabled discrimination of the effect direction. The size of the effect was estimated using Cohen's formula. The risk of bias and the overall evidence were assessed using the MEVORECH and GRADE methods, respectively. Eighty-five studies examining 261 predictors were included. We found a moderate quality of evidence for the harmful effects of the job demands subfamily (six predictors), and negative job attitudes, with effect sizes from small to medium. We also found a moderate quality of evidence for the protective effect of adaptive coping (small effect sizes) and leisure (small to medium effect sizes). Preventive interventions for occupational burnout might benefit from intervening on the established predictors regarding reducing job demands and negative job attitudes and promoting adaptive coping and leisure.

Harmonized definition of occupational burnout: A systematic review, semantic analysis, and Delphi consensus in 29 countries.

Objective A consensual definition of occupational burnout is currently lacking. We aimed to harmonize the definition of occupational burnout as a health outcome in medical research and reach a consensus on this definition within the Network on the Coordination and Harmonisation of European Occupational Cohorts (OMEGA-NET). Methods First, we performed a systematic review in MEDLINE, PsycINFO and Embase (January 1990 to August 2018) and a semantic analysis of the available definitions. We used the definitions of burnout and burnout-related concepts from the Systematized Nomenclature of Medicine Clinical Terms (SNOMED-CT) to formulate a consistent harmonized definition of the concept. Second, we sought to obtain the Delphi consensus on the proposed definition. Results We identified 88 unique definitions of burnout and assigned each of them to 1 of the 11 original definitions. The semantic analysis yielded a first proposal, further reformulated according to SNOMED-CT and the panelists` comments as follows: "In a worker, occupational burnout or occupational physical AND emotional exhaustion state is an exhaustion due to prolonged exposure to work-related problems". A panel of 50 experts (researchers and healthcare professionals with an interest for occupational burnout) reached consensus on this proposal at the second round of the Delphi, with 82% of experts agreeing on it. Conclusion This study resulted in a harmonized definition of occupational burnout approved by experts from 29 countries within OMEGA-NET. Future research should address the reproducibility of the Delphi consensus in a larger panel of experts, representing more countries, and examine the practicability of the definition.

Immunological Outcomes of Allergen-Specific Immunotherapy in Food Allergy.

IgE-mediated food allergies are caused by adverse immunologic responses to food proteins. Allergic reactions may present locally in different tissues such as skin, gastrointestinal and respiratory tract and may result is systemic life-threatening reactions. During the last decades, the prevalence of food allergies has significantly increased throughout the world, and considerable efforts have been made to develop curative therapies. Food allergen immunotherapy is a promising therapeutic approach for food allergies that is based on the administration of increasing doses of culprit food extracts, or purified, and sometime modified food allergens. Different routes of administration for food allergen immunotherapy including oral, sublingual, epicutaneous and subcutaneous regimens are being evaluated. Although a wealth of data from clinical food allergen immunotherapy trials has been obtained, a lack of consistency in assessed clinical and immunological outcome measures presents a major hurdle for evaluating these new treatments. Coordinated efforts are needed to establish standardized outcome measures to be applied in food allergy immunotherapy studies, allowing for better harmonization of data and setting the standards for the future research. Several immunological parameters have been measured in food allergen immunotherapy, including allergen-specific immunoglobulin levels, basophil activation, cytokines, and other soluble biomarkers, T cell and B cell responses and skin prick tests. In this review we discuss different immunological parameters and assess their applicability as potential outcome measures for food allergen immunotherapy that may be included in such a standardized set of outcome measures.

Outcomes for clinical trials of food allergy treatments.

OBJECTIVE: Food allergy is a common condition that can have a significant impact on the quality of life of affected individuals and their caregivers. Recent years have witnessed an increased effort to identify new treatments for food allergy. Here, we review the need to identify core outcomes for measurement in clinical trials of food allergy treatments. DATA SOURCES: We reviewed the literature regarding core outcome set development, the important role that these play in prioritizing patient-relevant outcomes, and the potential for core outcomes to accelerate the path to product marketing by allowing prompt and reliable evidence synthesis after trial publication. STUDY SELECTIONS: We reviewed recent clinical trials of food allergy treatments to understand which outcomes have previously been measured, and also reviewed available core outcome set initiatives for other allergic conditions to understand which other outcomes might be explored in future trials. RESULTS: Clinical trials of food allergy treatments have largely focused on outcomes that are relevant to investigators and commercial investors, especially the threshold of reactivity and immunologic changes. Future trials should consider addressing patient-important outcomes and should report the experiences of both adult and child participants and their caregivers. CONCLUSION: There is a pressing need for core outcome set development for food allergy treatment trials.

Asthma and Chronic Obstructive Pulmonary Disease Associated With Occupational Exposure in Dairy Farmers - Importance of Job Exposure Matrices.

AIM: To evaluate the prevalence of chronic respiratory symptoms, lung function impairment, and chronic obstructive respiratory diseases in dairy farmers. Our objective is to then examine their relation to exposure duration and to explore the usefulness of job exposure matrices as tools for exposure assessment, and predictors for respiratory health impairment. METHODS: A cross-sectional study was performed, including 83 dairy farmers (mean age: 52.6 ± 8.7 years; mean exposure duration: 23.7 ± 7.6 years) and 80 office workers as a control group (mean age: 52.7 ± 8.2 years) matched for age, smoking habits, and socioeconomic status. Methods of evaluating examined subjects included a questionnaire on respiratory symptoms in the last 12 months, spirometry and histamine challenge, as well as the use of job exposure matrices (JEM). RESULTS: Dairy farmers had a significantly higher prevalence of cough (38.5), phlegm (27.7%), and wheezing (21.7%), than controls (p < 0.05). All mean baseline spirometric parameters were lower in dairy farmers compared to the controls, but statistical significance was confirmed only for MEF25, MEF50, and MEF75% (p = 0.010, p = 0.001, and p = 0.004, respectively). The prevalence of bronchial hyperresponsiveness, asthma, and chronic obstructive pulmonary disease was higher in dairy farmers but without statistical significance. JEM were useful tools for exposure assessment and predictors of factors for asthma and COPD development. CONCLUSION: The results suggest that occupational exposure among crop farmers is associated with a higher prevalence of respiratory symptoms, lung function impairment, and a higher prevalence of chronic respiratory diseases. JEM showed good potential for farming exposure evaluation and promoted their applicability within the diagnostic algorithm focused on respiratory health assessment.

Effects of a Long-Term Use of Carbocysteine on Frequency and Duration of Exacerbations in Patients with Bronchiectasis.

BACKGROUND: The failure of mucus clearance in bronchiectasis can be improved by chest physiotherapy or/and mucoactive agents. AIM: To assess the effects of long-term use of carbocysteine on frequency and duration of exacerbations in patients with bronchiectasis. METHODS: We performed an observational, non-randomized, open study (a real-life study) including 64 patients with bronchiectasis divided into two groups, examined group (EG) and control group (CG). All participants were treated with appropriate treatment for the stable disease, but in the study, subjects of EG two capsules 375 mg carbocysteine three times a day was added over three months. Daily diary cards realised collection of data regarding the occurrence and duration of exacerbation in all study subjects. RESULTS: Over the study period 43 exacerbations were documented, 17 in the EG and 26 in the CG, 10 (23.4%) of which required hospital treatment (four in the EG [23.5%] and six in the CG [23.1%]). A mean number of exacerbations over the study period was significantly lower in the EG (0.5 ± 0.1) as compared to their mean number in the CG (0.8 ± 0.2) (P = 0.0000). Mean duration of exacerbations expressed in days needed for complete resolution of symptoms or return of the symptoms to their baseline severity in the EG was significantly shorter than the mean duration of exacerbations in the CG (10.1 ± 2.6 vs 12.8 ± 2.1; P = 0.0000). The frequency of adverse effects, i.e. mild gastrointestinal manifestations and headache which did not require discontinuation of the treatment, in the EG during the study period was 15.6%. CONCLUSION: Our findings indicated positive effects of carbocysteine regarding the frequency and duration of exacerbations, as well as its good tolerability in the patients with bronchiectasis.

Moxifloxacin in the Outpatient Treatment of Moderate Exacerbations of Chronic Obstructive Pulmonary Disease.

BACKGROUND: Bacterial infections are involved in more than a half of the exacerbations of chronic obstructive pulmonary disease (COPD). AIM: To evaluate the efficacy and safety of moxifloxacin in the outpatient treatment of moderate exacerbations of bacterial origin in the COPD patients. METHODS: We performed a prospective, observational study including 64 COPD patients with moderate exacerbation of bacterial origin empirically treated with moxifloxacin. In 31 of them, moxifloxacin was used as an initial antibiotic (Group 1), whereas in 33 of them moxifloxacin was used after treatment failure with another antibiotic (Group 2). All patients have treated 7 days with moxifloxacin 400 mg once daily per os, and they were followed up for 20 days, with an intermediate visit at 3, 5 and 7 days at which the duration of symptoms and the side effects of the drug were evaluated. RESULTS: We registered high clinical success rate, i.e. the complete resolution of the symptoms or their return to the baseline severity, similar in both groups (84.3% in all study subjects, 83.9% in the Group 1 and 84.8% in the Group 2). The mean time to complete resolution of the cardinal symptoms or their return to the baseline severity was 5.2 ± 1.1 days. Also, the mean time to complete resolution of the certain cardinal symptoms (increased dyspnea, increased sputum volume and increased sputum purulence) or their return to the baseline severity is given 4.9, 4.7 and 4.2 days, respectively. The incidence of adverse effects during the treatment with moxifloxacin in all study subjects was 10.9%, 9.6% in Group 1 and 12.1% in Group 2. There was no serious adverse effect that required discontinuation of the treatment. Relapse during a 20 days follow-up period was registered in 7.4% of the all study subjects with complete resolution of the cardinal symptoms or their return to the baseline severity, i.e. in two patients from both Group 1 and Group 2 (7.6% and 7.1%, respectively). 4. CONCLUSION: Our findings suggest high efficacy and good tolerability of moxifloxacin in the treatment of moderate COPD exacerbations of bacterial origin.

Job Demands, Burnout, and Teamwork in Healthcare Professionals Working in a General Hospital that Was Analysed At Two Points in Time.

AIM: The purpose of the paper was to assess job demands, burnout, and teamwork in healthcare professionals (HPs) working in a general hospital that was analysed at two points in time with a time lag of three years. METHODS: Time 1 respondents (N = 325) were HPs who participated during the first wave of data collection (2011). Time 2 respondents (N = 197) were HPs from the same hospital who responded at Time 2 (2014). Job demands, burnout, and teamwork were measured with Hospital Experience Scale, Maslach Burnout Inventory, and Hospital Survey on Patient Safety Culture, respectively. RESULTS: Significantly higher scores of emotional exhaustion (21.03 vs. 15.37, t = 5.1, p < 0.001), depersonalization (4.48 vs. 2.75, t = 3.8, p < 0.001), as well as organizational (2.51 vs. 2.34, t = 2.38, p = 0.017), emotional (2.46 vs. 2.25, t = 3.68, p < 0.001), and cognitive (2.82 vs. 2.64, t = 2.68, p = 0.008) job demands were found at Time 2. Teamwork levels were similar at both points in time (Time 1 = 3.84 vs. Time 2 = 3.84, t = 0.043, p = 0.97). CONCLUSION: Actual longitudinal study revealed significantly higher mean values of emotional exhaustion and depersonalization in 2014 that could be explained by significantly increased job demands between analysed points in time.

Eosinophil Cationic Protein Concentrations among Crop and Dairy Farmers with Asthma.

OBJECTIVE: To assess the mean serum eosinophil cationic protein (s-ECP) concentrations among crop and dairy farmers and office controls, and further examine its relation to exposure duration, smoking habit, as well as presence or absence of asthma. METHODS: A cross-sectional survey was performed including examined group (EG), composed by agricultural workers (87 crop - EG1 and 83 dairy farmers - EG2), and control group (CG) composed by 80 office workers within the same enterprise. We have used a questionnaire to record the chronic respiratory symptoms, detailed work history, specific farming activities and tasks performed and smoking history. Evaluation of examined subjects also included lung function tests, diagnosis of asthma, and measurement of s-ECP as a marker of inflammation. RESULTS: The main finding of the present study is that s-ECP concentrations were raised in subjects with asthma independent of the smoking habit. The mean s-ECP concentrations were higher in subjects of EG1 and EG2 compared with those in CG, but without reaching statistical significance. Mean s-ECP concentrations were significantly higher among subjects in EG1 exposed more than 20 years, while mean s-ECP concentrations were non-significantly higher in subjects of EG2 exposed more than 20 years, compared to those exposed less than 20 years. Mean s-ECP concentrations were higher among smokers within all three groups, but without reaching statistical significance between smokers and non-smokers. Mean s-ECP concentrations were significantly higher in subjects with asthma within EG1 (P = 0.049) and EG2 (P = 0.040), but also within those in CG (P = 0.046). CONCLUSION: Data obtained suggest that airway inflammation is present in farmers with asthma, and s-ECP is an important biomarker in means of reflecting disease severity and prognosis among exposed workers.

C-Reactive Protein Concentrations Among Crop and Dairy Farmers with Stable Chronic Obstructive Pulmonary Disease.

AIM: To assess the mean serum C-reactive protein concentrations among farmers and office controls, and further examined its relation to exposure duration, smoking habit, as well as presence or absence of COPD. METHODS: A cross-sectional survey was performed including examined group (EG), composed of agricultural workers (87 crop - EG1 and 83 dairy farmers - EG2), and control group (CG) composed by 80 office workers. Evaluation of subjects included a questionnaire on chronic respiratory symptoms, lung function tests, COPD diagnostics, and measurement of CRP serum concentrations. RESULTS: Serum CRP concentrations were raised in stable COPD patients independent of smoking habit or exposure duration. The mean CRP serum concentrations were higher in the subjects of EG1 and EG2 compared with those in CG, but without statistical significance. This count for mean CRP serum concentrations in subjects of EG1 and EG2 exposed more than 20 years and for those in smokers in all three groups as well. The mean CRP serum concentrations were significantly higher in subjects with COPD within EG1 (P=0.049) and EG2 (P=0.040), while those in CG were not. CONCLUSION: Data obtained suggest that systemic inflammation is present in farmers with COPD and CRP is an important biomarker in COPD in means of reflecting disease severity and prognosis of exposed farmers.

Exacerbations in COPD Patients with Bronchiectasis.

There is evidence that coexisting bronchiectasis (BE) in patients with chronic obstructive pulmonary disease (COPD) aggravates the course of the disease. In this study, we aimed to evaluate the frequency and severity of bacterial exacerbations in COPD patients with BE. The frequency and duration of bacterial exacerbations treated in a 12-month period, as well as the duration of the exacerbation-free interval, were evaluated in 54 patients with COPD (Group D) who were diagnosed and assessed according to official recommendations. In 27 patients, BE was diagnosed by high-resolution computed tomography (HRCT), whereas an equal number of COPD patients who were confirmed negative for BE by HRCT, served as controls. We found a significantly higher mean number of exacerbations in a 12-month period in COPD patients with BE (2.9 ± 0.5), as compared to their mean number in controls (2.5 ± 0.3) (p = 0.0008). The mean duration of exacerbation, i.e. the mean number of days elapsed before complete resolution of the symptoms or their return to the baseline severity, was significantly longer in COPD patients with BE as compared to their mean duration in controls (6.9 ± 1.8 vs. 5.7 ± 1.4; p = 0.0085). In addition, the mean exacerbation-free interval expressed in days, in patients with COPD with BE, was significantly shorter than in COPD patients in whom BE were excluded (56.4 ± 17.1 vs. 67.2 ± 14.3; p = 0.0149). Overall, our findings indicate that coexisting BE in COPD patients may lead to more frequent exacerbations with a longer duration.

Effects of Pleuran (Β-Glucan from Pleurotus Ostreatus) Supplementation on Incidence and Duration of COPD Exacerbations.

BACKGROUND: 1,3/1,6-ß-glucans are recognised as immunomodulators in human and veterinary medicine for over 50 years. AIM: To assess the effects of pleuran (1,3/1,6-ß-glucan from Pleurotus ostreatus) on incidence and duration of bacterial exacerbations in patients with COPD. METHODS: We performed an observational, non-randomized, open-label study including 32 COPD patients (Group D) in whom besides the recommended chronic treatment for the stable disease were administered supplement combination containing pleuran 100 mg, vitamin C 60 mg and zinc 5 mg once daily over a three month-period (Group 1). Also, an equal number of Group D COPD patients who besides the recommended treatment for stable disease received the supplement combination containing vitamin C 60 mg and zinc 5 mg once daily, matched to the study subjects of the Group 1 by sex and age served as control (Group 2). RESULTS: Over the study period 57 exacerbations (24 in the Group 1 and 33 in the Group 2) were documented. A mean number of exacerbations over the study period was significantly lower in the Group1 (0.7 ± 0.4) as compared to their mean number in the Group 2 (1.0 ± 0.6) (P = 0.0218). Furthermore, a mean duration of exacerbations expressed in days needed for cure or clinical improvement (i.e. complete resolution of symptoms or return of the symptoms to their baseline severity) in the Group 1 (6.7 ± 0.8 days) was significantly shorter than the mean duration of exacerbations in the Group 2 (7.4 ± 1.3 days) (P = 0.0118). There was not reported any adverse effect during the study period by study subjects from both examined groups. CONCLUSION: Our findings indicated that pleuran might impact the incidence and duration of bacterial exacerbations in patients with COPD. There is a need for further studies for more precise determination of the influence of pleuran on the course of COPD.