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Introduction: N-acetylcysteine (NAC) is a mucolytic agent with antioxidant properties. Oxidative stress is a key pathogenic mechanism in chronic respiratory conditions such as COPD and chronic bronchitis (CB). In these meta-analyses we investigated the efficacy of NAC in subjects with COPD or CB, the latter being a potential pre-COPD condition (CB/pre-COPD)., Methods: The meta-analyses were conducted according to PRISMA guidelines. Exacerbations were assessed using total number of exacerbations. Improvement in patients' respiratory symptoms and/or patients quality of life (QoL) were measured by validated tools or assessed at the end of the study., Results: Twenty studies were included, of which seven evaluated NAC in patients with symptoms of CB/pre-COPD as entry criterion. NAC treated patients showed a significant reduction of the incidence of exacerbations as compared to placebo both in COPD (IRR=0.76; 95% confidence interval (CI) 0.59-0.99) and CB/pre-COPD (IRR=0.81; 95% CI 0.69-0.95). Sensitivity analyses in studies with duration higher than 5 months, confirmed the overall results. CB/pre-COPD patients treated with NAC were significantly more likely to experience an improvement in symptoms and/or QoL compared to placebo (odds ratio (OR)=3.47; 95% CI 1.92-6.26). A similar trend was observed in the few COPD studies evaluable. Sensitivity analyses showed a significant association of NAC with improvement in symptoms and/or QoL both in CB/pre-COPD and COPD patients., Conclusions: These findings provide novel data of NAC on the improvement in symptoms and QoL in addition to prevention of exacerbations in COPD and CB/pre-COPD. PROSPERO registry no. CRD42023468154., (Copyright © 2024 The Authors. Published by Elsevier España, S.L.U. All rights reserved.)

Background: The concept of clinical control has been proposed as an instrument for evaluating patients with COPD. However, the possible association between clinical control, reduced symptom severity and HRQoL has yet to be confirmed., Methods: This multicentre, prospective and observational study was carried out in 15 pulmonology clinics in Spain. The patients were followed up for six months, with a baseline visit (V0), followed by visits at three months (V1) and six months (V2). Clinical control was determined at V1, with the application of both clinical criteria and the COPD assessment test (CAT). All patients reported their symptoms by a validated symptom diary (E-RS) using a portable device, and their HRQoL was assessed using the EQ5D questionnaire. The relationship between clinical control and E-RS and HRQoL during follow-up was assessed with t -test., Results: A total of 126 patients were screened. After application of the inclusion/exclusion criteria, 93 were finally included (mean age 66 ± 8 years, 84.9% male), with a mean FEV 1 predicted of 49.8% ± 16.5%. Of these patients, 44 (47.3%) achieved clinical control at V1, according to CAT criteria, and 50 (53.8%), according to clinical criteria. The E-RS scores differed between controlled and uncontrolled patients at all time points, both according to CAT (mean differences of -4.6, -5.6 and -6.2 units at V0, V1 and V2, respectively, p<0.005 for all comparisons) and to clinical criteria (mean differences of -3.3, -5-6 and -4.99 units, respectively, p<0.005 for all comparisons). The controlled patients also presented a significantly better HRQoL, measured by the EQ5D questionnaire (mean difference 0.13 and 0.10 at V2 by CAT or clinical criteria, respectively, p<0.05)., Conclusion: Clinical control in patients with COPD, whether measured by CAT or by clinical criteria, is associated with a lower symptom load and a better HRQoL., Competing Interests: Dr. Alcázar-Navarrete reports grants, non-financial support and personal fees from GSK, grants, personal fees and non-financial support from Novartis AG, personal fees and non-financial support from Boehringer Ingelheim, personal fees and non-financial support from Chiesi, grants, personal fees and non-financial support from Laboratorios Menarini, personal fees from Gebro, personal fees and non-financial support from Astra-Zeneca, personal fees from Laboratorios Rovi, personal fees from Laboratorios Ferrer, grants, personal fees, non-financial support from Menarini, outside the submitted work. Dra. Fuster has nothing to disclose. Dra García-Sidro reports personal fees from GSK, Pfizer, Novartis AG, Menarini, Boehringer Ingelheim, Astra-Zeneca, Gebro and Laboratorios Rovi, outside the submitted work. Dr. García Rivero has nothing to disclose. Dr. Abascal-Bolado has nothing to disclose. Dr. Pallarés-Sanmartín has received lecture fees, consultancy fees and/or support for conference attendance from various pharmaceutical companies such as Novartis, GlaxoSmithKline, Chiesi, Boehringer Ingelheim, Mundipharma, Menarini, Laboratorios Esteve, Astra Zeneca, Teva Pharmaceutical, Ferrer, Rovi, Bial, Faes Farma, ALK Abelló and Gebro Pharma outside the submitted work. Dr. Marquez- Martín has nothing to disclose. Dr. Valido Morales has received lecture fees, consultancy fees and/or support for conference attendance from various pharmaceutical companies, such as GlaxoSmithKline, Chiesi, Boehringer Ingelheim, Menarini, Pfizer, Novartis, Laboratorios Esteve, Teva Pharmaceutical, Ferrer, Rovi, Astra Zeneca, Bial, Grifols, Faes Farma and Gebro Pharma, outside the submitted work. Dr. Callejas González has received lecture fees, consultancy fees and/or support for conference attendance from various pharmaceutical companies, such as GlaxoSmithKline, Chiesi, Boehringer Ingelheim, Mundipharma, Menarini, Pfizer, Novartis, Laboratorios Esteve, Teva Pharmaceutical, Ferrer, Rovi, Roche, Astra Zeneca, Bial, Actelion, Grifols, CSL Behring, Faes Farma and Gebro Pharma, and reports personal fees from GlaxoSmithKline, personal fees from Chiesi, personal fees from Boehringer Ingelheim, personal fees from Mundipharma, personal fees from Menarini, personal fees from Pfizer, personal fees from Novartis, personal fees from Laboratorios Esteve, personal fees from Teva Pharmaceutical, personal fees from Ferrer, personal fees from Rovi, personal fees from Roche, personal fees from Astra Zeneca, personal fees from Bial, personal fees from Actelion, personal fees from Grifols, personal fees from CSL Behring, personal fees from Faes Farma, personal fees from Gebro Pharma, outside the submitted work. Dra. Palop reports personal fees from Astra Zeneca, GlaxoSmithKline, Chiesi, Boehringer -Ingelheim, Novartis, Teva, Menarini, Rovi, outside the submitted work. Dr. JA Riesco reports grants and personal fees from GSK, grants, personal fees and non-financial support from Pfizer, Novartis AG, Menarini, personal fees and non-financial support from Boehringer Ingelheim, personal fees and non-financial from Astra-Zeneca, Grants and personal fees from Gebro, personal fees from Laboratorios Rovi, outside the submitted work. Dr. Golpe reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Menarini, Rovi, Zambon, Grifols, Novartis, Ferrer, Gebro Pharma, Laboratorios Esteve and GlaxoSmithKline, outside the submitted work. Dr. Soler-Cataluña reports speaking fees from Laboratorio Esteve, Mundipharma, grants, personal fees, speaking fees from AstraZeneca, grants, personal fees, non-financial support from Boehringer Ingelheim, personal fees from Bial, personal fees from Ferrer, personal fees, non-financial support from Menarini, personal fees, non-financial support from Novartis, personal fees from Rovi and Teva; consulting fees from AirLiquide, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Laboratorios Esteve, Mundipharma grants, personal fees from Chiesi, personal fees from Ferrer, grants, personal fees from; research grants from GlaxoSmithKline and Boehringer Ingelheim, outside the submitted work. Marc Miravitlles has received speaker fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Menarini, Rovi, Bial, Sandoz, Zambon, CSL Behring, Grifols and Novartis, consulting fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Bial, Gebro Pharma, Kamada, CSL Behring, Laboratorios Esteve, Ferrer, Mereo Biopharma, Verona Pharma, TEVA, Spin Therapeutics, pH Pharma, Novartis, Sanofi and Grifols and research grants from GlaxoSmithKline and Grifols; reports personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Menarini, Rovi, Bial, Sandoz, Zambon, CSL Behring, Grifols and Novartis, personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Bial, Gebro Pharma, Kamada, CSL Behring, Laboratorios Esteve, Ferrer, Mereo Biopharma, Verona Pharma, TEVA, Spin Therapeutics, pH Pharma, Novartis, Sanofi and Grifols, grants from GlaxoSmithKline and Grifols., outside the submitted work. The authors report no other potential conflicts of interest for this work., (© 2020 Alcazar-Navarrete et al.)

Purpose: On March 16, 2020, the Spanish government declared a state of alarm due to the rapid spread of coronavirus disease 2019 (COVID-19). Patients with chronic obstructive pulmonary disease (COPD) were restricted to remain confined at home, and medical visits were cancelled for 3 months. The impact of this lockdown on the manifestations of COPD and the quality-of-life of these patients has not been explored., Patients and Methods: One hundred patients with COPD were interviewed by telephone from May 2-18, 2020. The interviews included questions about the lockdown, missed medical appointments, fears of the disease, possible COVID-19 infection, and exacerbations of COPD suffered during this period and their management. In addition, the COPD Assessment Test, the Hospital Anxiety and Depression, and the 5-Dimension Euro Quality-of-Life questionnaires were administered., Results: Sixty-four (64%) patients claimed to have strictly complied with the lockdown, and only 42 (42%) stated they had left home at least once during lockdown. Only one patient (1%) was hospitalized due to COVID-19, and 13 (13%) patients presented an exacerbation of COPD self-managed at home with no admissions due to exacerbation of COPD during this period. A medical consultation or complementary test was cancelled in 90% of the patients, but 61% had a medical telephone visit with a high degree of satisfaction (mean 9.3/10). Most patients declared that their feeling regarding lung disease and general health was similar or even better during lockdown (82% and 81%, respectively)., Conclusion: Our results indicate that in general lockdown had a low impact on COPD patients. Only one patient was affected by COVID-19, but moderate exacerbations of COPD were not infrequent. Although many medical visits and test were cancelled, patients were very satisfied with the medical telephone visits., Competing Interests: Marc Miravitlles has received speaker fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, Menarini, Rovi, Bial, Sandoz, Zambon, CSL Behring, Grifols, and Novartis, consulting fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Bial, Gebro Pharma, Kamada, CSL Behring, Laboratorios Esteve, Ferrer, Mereo Biopharma, Verona Pharma, TEVA, Spin Therapeutics, pH Pharma, Novartis, Sanofi, and Grifols, and research grants from GlaxoSmithKline and Grifols, outside the submitted work, and reports no other potential conflicts of interest in this work. The remaining authors have no conflicts of interest to disclose for this work., (© 2020 Pleguezuelos et al.)

Purpose: Impaired health-related quality of life (HRQoL) is associated with poor health outcomes in chronic obstructive pulmonary disease (COPD). The aim of this study was to determine health utilities in patients with COPD and to identify the variables with the greatest impact., Methods: This is a pooled analysis of data from 4 observational studies performed in stable COPD patients. Evaluation of patient HRQoL utilities was performed using the Spanish version of the self-administered EuroQoL 5 Dimensions (EQ-5D) questionnaire. EQ-5D utilities were described and compared according to several markers of disease severity., Results: 6198 patients reported a mean (SD) EQ-5D index of 0.67 (0.26). A linear dose response relationship between EQ-5D utility and modified Medical Research Council (mMRC) score, forced expiratory volume in one 1 s (% predicted), COPD hospital admissions in the previous year, self-reported daily walking time, Charlson index, body mass index, obstruction, dyspnoea and exacerbation (BODEx) index, COPD assessment test (CAT), hospital anxiety and depression scale was observed (p for trend < 0.001). In multivariate analysis, patients reporting lower utility values were those with more dyspnoea, more comorbidities, using long-term oxygen therapy, with previous hospitalisations due to a COPD exacerbation and higher (worse) CAT score., Conclusion: HRQoL measures such as EQ-5D can assist clinicians to understand the impact of respiratory disease on COPD patients.

Chronic obstructive pulmonary disease (COPD) imposes a substantial burden on individuals with the disease, which can include a range of symptoms (breathlessness, cough, sputum production, wheeze, chest tightness) of varying severities. We present an overview of the biomedical literature describing reported relationships between COPD symptoms and disease burden in terms of quality of life, health status, daily activities, physical activity, sleep, comorbid anxiety, and depression, as well as risk of exacerbations and disease prognosis. In addition, the substantial variability of COPD symptoms encountered (morning, daytime, and nighttime) is addressed and their implications for disease burden considered. The findings from this narrative review, which mainly focuses on real-world and observational studies, demonstrate the impact of COPD symptoms on the burden of disease and that improved recognition and understanding of their impact is central to alleviating this burden.

Chronic obstructive pulmonary disease (COPD) is associated with high morbidity and mortality. COPD is typified by persistent, progressive airflow limitation and a range of respiratory and systemic symptoms such as breathlessness, coughing, wheezing, depression, anxiety, general fatigue, and sleeping difficulties. Despite receiving treatment for COPD, many patients suffer from regular symptoms that affect their daily lives and lead to increased morbidity. These symptoms vary in severity, frequency, and type, and can occur at any time throughout the 24-h day, with over half of patients with COPD experiencing symptoms in the morning, during the day, and at nighttime. Despite the prevalence of symptoms, patient and physician perception of the impact of COPD symptoms on patients' lives is not always in concordance. Dual bronchodilator therapy with a long-acting muscarinic antagonist (LAMA) and long-acting beta agonist (LABA) has the potential to treat the symptoms of COPD in addition to improving lung function. This review therefore examines the burden of symptoms experienced throughout the day by patients with COPD and the evidence for combined LAMA/LABA treatment in terms of symptom management. As patients with COPD experience varying symptoms throughout the course of their disease, the role of tailoring treatment to the individual needs of the patient is also examined. We conclude that the symptoms of COPD are troublesome, variable, can occur during all parts of the 24-h day, and have a substantial impact on patients' health status and quality of life. In order to provide effective, patient-orientated care, patients with COPD should be evaluated on the basis of lung function, the frequency of symptoms, and patient-perceived impact of symptoms on their lives. Therapy should be chosen carefully based on individualized assessment, ensuring personalization to the individual needs of the patient.

Introduction: Depression is a prevalent comorbidity in COPD and has an impact on the prognosis of these patients, thereby making it important to study the factors associated with depression in patients with COPD., Method: A multicenter, observational and cross-sectional study was conducted to study the factors associated with depression in patients with COPD measured by the hospital anxiety and depression (HAD) questionnaire. We analyzed anthropometric variables and the number of exacerbations in the previous year and calculated the 6-min walking test and the body mass index, airflow obstruction, dyspnea, and exercise (BODE) index. All the patients completed the quality of life EQ-5D and the LCADL physical activity questionnaires. The relationship of these variables with depression was evaluated with two multiple logistic regression models., Results: One hundred fifteen patients were evaluated (93 % male) with a mean age of 66.9 years (SD 8.8) and a mean FEV1 % of 44.4 % (SD 15.7 %). 24.3 % presented symptoms of depression (HAD-D > 8). These latter patients had worse lung function, greater dyspnea, reduced exercise capacity, a higher score in the BODE index, poorer quality of life, reduced physical activity, and more exacerbations. In the first logistic regression model, quality of life and the BODE index were associated with depression (AUC: 0.84; 0.74-0.94). In the second model including the variables in the BODE index, quality of life and dyspnea measured with the MRC scale (AUC: 0.87; 0.79-0.95) were associated with depression., Conclusions: Nearly one-quarter of the patients with COPD in this study presented clinically significant depression associated with worse quality of life, reduced exercise capacity, greater dyspnea, and a higher score in the BODE index.

Background: To determine generic utilities for Spanish chronic obstructive pulmonary disease (COPD) patients stratified by different classifications: GOLD 2007, GOLD 2013, GesEPOC 2012 and BODEx index., Methods: Multicentre, observational, cross-sectional study. Patients were aged ≥40 years, with spirometrically confirmed COPD. Utility values were derived from EQ-5D-3 L. Means, standard deviations (SD), medians and interquartile ranges (IQR) were computed based on the different classifications. Differences in median utilities between groups were assessed by non-parametric tests., Results: 346 patients were included, of which 85.5% were male with a mean age of 67.9 (SD = 9.7) years and a mean duration of COPD of 7.6 (SD = 5.8) years; 80.3% were ex-smokers and the mean smoking history was 54.2 (SD = 33.2) pack-years. Median utilities (IQR) by GOLD 2007 were 0.87 (0.22) for moderate; 0.80 (0.26) for severe and 0.67 (0.42) for very-severe patients (p < 0.001 for all comparisons). Median utilities by GOLD 2013 were group A: 1.0 (0.09); group B: 0.87 (0.13); group C: 1.0 (0.16); group D: 0.74 (0.29); comparisons were statistically significant (p < 0.001) except A vs C. Median utilities by GesEPOC phenotypes were 0.84 (0.33) for non exacerbator; 0.80 (0.26) for COPD-asthma overlap; 0.71 (0.62) for exacerbator with emphysema; 0.72 (0.57) for exacerbator with chronic bronchitis (p < 0.001). Comparisons between patients with or without exacerbations and between patients with COPD-asthma overlap and exacerbator with chronic bronchitis were statistically-significant (p < 0.001). Median utilities by BODEx index were: group 0-2: 0.89 (0.20); group 3-4: 0.80 (0.27); group 5-6: 0.67 (0.29); group 7-9: 0.41 (0.31). All comparisons were significant (p < 0.001) except between groups 3-4 and 5-6., Conclusion: Irrespective of the classification used utilities were associated to disease severity. Some clinical phenotypes were associated with worse utilities, probably related to a higher frequency of exacerbations. GOLD 2007 guidelines and BODEx index better discriminated patients with a worse health status than GOLD 2013 guidelines, while GOLD 2013 guidelines were better able to identify a smaller group of patients with the best health.

Alpha-1-antitrypsin deficiency (AATD) is an inherited disorder responsible for early onset emphysema associated with a significant impairment of health-related quality of life (HRQoL). Our aim was to assess the usefulness of different instruments to evaluate the HRQoL in patients with AATD compared to non-AATD COPD. Observational, cross-sectional study in which all patients filled out a series of questionnaires: the COPD severity score (COPDSS), the EuroQoL 5-Dimensions (EQ-5D), the Living with COPD (LCOPD) and the COPD Assessment Test (CAT). A total of 96 patients were included, 35 with AATD (mean age 56.5 yrs, 57.1% male and mean FEV1(%) 48.7% and 61 non-AATD COPD (70.3 yrs, 80.3% men and FEV1(%) 47%. The questionnaire scores were similar, with a tendency towards worse scores in AATD for the EQ-5D (VAS) (64.8 (20.2) vs. 71.6 (17.1); p = 0.08). The correlations between the different scores and FEV1(%) were significant in both groups for COPDSS and LCOPD, but not for CAT and EQ-5D. In general, the correlations of scores with FEV1(%) were stronger for AATD compared with non-AATD COPD patients: COPDSS r = -0.570, p < 0.01 for AATD and r = -0.260, p < 0.05 for COPD; LCOPD r = -0.502, p < 0.001 for AATD and r = -0.304, p < 0.05 for non-AATD COPD. Patients with AATD have a similar degree of HRQoL impairment as older subjects with non-AATD COPD and showed a stronger correlation between HRQoL measurements and lung function impairment compared with non-AATD COPD. This may be related to the characteristics of the disease in these patients who are usually younger, with less co-morbidity and lower smoking consumption.

Background: A primary objective in the treatment of patients with chronic obstructive pulmonary disease (COPD) is to improve their health status., Objective: To identify the factors associated with changes in health-related quality of life (HRQoL) in patients with COPD after one year of follow-up in primary care., Method: Multicenter, prospective study with one year of follow-up. The end-point was the change in total score on the Saint George's Respiratory Questionnaire (SGRQ). Patients with a clinically relevant (>4 points) decrease or increase in SGRQ total score were compared. Factors associated with the changes in HRQoL observed after one year were determined by logistic regression analysis., Results: A total of 791 patients (mean age, 70.2 years) were analyzed. Mean FEV1 (% predicted) was 52.4%. Average total SGQR score was 37.1 (SD = 19.1) at baseline and 35.6 (SD = 18.9) at follow-up. Significantly improved HRQoL was observed in 36.7% of patients, and was associated with starting polymedication, pulmonology visits, and balanced diet; ending respiratory rehabilitation, quitting smoking; and not being a frequent exacerbator. Quality of life worsened significantly in 29.2% of patients, and was associated with worsening respiratory symptoms and increased hospital admissions., Conclusions: Although overall changes in HRQoL observed after one year were minimal, more than one third of patients improved significantly, and one third had significantly worse HRQoL. Clinical factors were independently associated with these changes, emphasizing the relevance to improved HRQoL of starting a healthy lifestyle and respiratory treatments and the negative impact on HRQoL of COPD symptoms onset and admissions., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Objective: The living with chronic obstructive pulmonary disease (LCOPD) scale was developed in the United Kingdom and the United States to assess the quality of life (QoL) of people with chronic obstructive pulmonary disease. The scale was shown to be well accepted by patients, to be unidimensional, and to have very good psychometric properties. This article reports on the adaptation of the measure for use in representative Southern European (Italian and Spanish) and Eastern European (Russian) languages., Study Design and Setting: The same methodology was used in each country: translation panels were held to produce new language versions. These were then tested with patients to ensure face and content validity. Finally, test-retest postal surveys were conducted to establish internal consistency, reproducibility, and construct validity., Results: Few problems were found in translating the LCOPD, and patient interviews indicated that the measure was considered relevant and easy to complete. The validation surveys showed that the new versions of the LCOPD were consistent, reproducible, and had good construct validity. The psychometric properties of the new versions were similar to those found for the original U.K. and U.S. versions., Conclusion: The study was successful in adapting the LCOPD for use in Southern and Eastern European languages., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Background: There is ample evidence of the differences between genders in chronic obstructive pulmonary disease (COPD). The purpose of this study was to identify the factors that contribute to these differences., Methods: This was a multi-center, cross-sectional observational study including 4574 patients of 40 years of age and older who attended primary care and pulmonary clinics. Data were collected on COPD characteristics, comorbidities, quality of life as assessed by both the EuroQoL 5D questionnaire (EQ-5D) and the Airways Questionnaire 20 (AQ20), and prevalence of anxiety and depression. Data collected were compared between males and females., Results: Mean age was 67 years and 740 patients (16.7%) were female. Women were significantly younger, had better pulmonary function, and smoked less; however, they showed poorer quality of life (EQ-5D: 0.6 [SD = 0.3] versus 0.7 [0.3]; p < 0.001; and AQ20: 10.4 [SD = 4.6] versus 9.2 [SD = 4.5]; p < 0.001) and a higher rate of anxiety (34.5% versus 20.6%; p < 0.001) and depression (31.7% versus 22.1%; p < 0.001). In a multivariate analysis, female gender was significantly associated to poorer quality of life (AQ20) but not to a higher rate of dyspnea., Conclusion: Women with COPD are younger and have lower rates of impaired lung function; however, they show poorer quality of life and more frequent COPD-associated anxiety and depression., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Background: The current debate about the lower limit of normal (LLN) vs the 0.7 fixed ratio to diagnose COPD is not completely resolved, and little information about the clinical impact of these different criteria is available. We compared differences in health-related quality of life, exacerbations, exercise tolerance, physical activity, comorbidity, and systemic biomarkers of subjects with FEV(1)/FVC < 0.7 but > LLN (ratio-only group) vs subjects without COPD and those with mild or moderate to severe COPD., Methods: A population-based sample of 3,802 subjects aged 40 to 80 years from the Epidemiologic Study of COPD in Spain was selected. Subjects were evaluated with postbronchodilator spirometry, quality-of-life and physical activity questionnaires, and 6-min walk tests. Exacerbations within the previous year and comorbidities were recorded. Systemic biomarkers were measured after excluding subjects with conditions associated with systemic inflammatory processes., Results: Fixed-ratio COPD overdiagnosis affects up to 4.6% of subjects aged 40 to 80 years, is more frequent in men, and increases with age. After adjusting for confounding factors, the ratio-only group had a worse health-related quality of life than the non-COPD group, with poorer scores in all questionnaire domains (P < .05). However, no differences between the two groups for respiratory exacerbations, 6-min walk distance, physical activity, or systemic biomarkers were observed. Ratio-only subjects did not present greater risk for cardiovascular disease (adjusted relative OR, 1.47; 95% CI, 0.81-2.64), whereas subjects with mild COPD did (adjusted relative OR, 2.32; 95% CI, 1.11-4.84)., Conclusions: Subjects receiving a diagnosis of COPD by the fixed ratio present worse self-reported quality of life than subjects without COPD but had similar exercise, frequency of exacerbations, and indices of systemic effects.

Background: Socioeconomic status (SES) is an important determinant of health and premature death. However, the impact of poor SES on the health status of patients with chronic obstructive pulmonary disease (COPD) has not been well determined., Objective: It was our aim to assess the impact of SES on the quality of life in COPD patients., Methods: This was a cross-sectional, observational, multicenter study. A total of 4,574 patients completed the EuroQol 5-dimension questionnaire (EQ-5D) and the Airways Questionnaire 20 (AQ20). SES was based on the subject's occupation and educational level. Occupational categories were based on the major group classification of the International Standard Classification of Occupations., Results: The mean age of the population was 67.1 years and the mean forced expiratory volume was 43.4%. There was a gradient of impairment in health-related quality of life (HRQoL) according to the educational level, with significantly worse scores for the EQ-5D and the AQ20 for medium and low educational levels compared with high education (p < 0.001). Similarly, HRQoL was also significantly impaired in more unskilled workers, with a gradient of the AQ20 from 8.6 units (SD 4.8) in class I to 10.1 units (4.6) in class V (p < 0.001) and from 0.75 units in class I to 0.63 units in class V for the EQ-5D index, as well as from 62.9 units in class I to 55.6 units in class V for the EQ-5D visual analogue scale (p < 0.001 for all comparisons). These differences remained significant after controlling for covariates., Conclusions: Patients with a lower educational level and belonging to the unskilled professional groups had a poorer HRQoL. This is evident even in a country where access to health care services is universal and free., (Copyright © 2011 S. Karger AG, Basel.)

Objective: To investigate the impact of exacerbations in health-related quality of life (HRQL) of patients with COPD and to compare the effect of treatment of COPD exacerbations with moxifloxacin (400 mg/day for 5 days) and amoxicillin/clavulanate (500/125 mg 3 times a day for 10 days) on HRQL., Methods: 229 outpatients with stable COPD (mean age 68.2 years; mean FEV(1) % predicted 49.3%) participated in a prospective, observational study of 2 years' duration. The St George's Respiratory Questionnaire (SGRQ) was completed at baseline and every 6 months thereafter., Results: COPD exacerbations (mean 2.7 episodes/patient) occurred in 136 patients (124 patients received the study medications [amoxicillin/clavulanate 54, moxifloxacin 70]). Differences between baseline and the final visit were higher for moxifloxacin compared with amoxicillin/clavulanate for total SGRQ score (-2.60 [13.1] vs 4.21 [16.2], P = 0.05) and "Symptoms" subscale (-5.64 [16.7] vs 8.27 [21], P = 0.02). The same findings were observed in patients with two or more exacerbations., Conclusions: In COPD outpatients, treatment of exacerbations with moxifloxacin had a more favorable long-term effect on quality of life than amoxicillin/clavulanate.

Background and Objective: AM3 is an immunomodulator that significantly improves the quality of life of patients with chronic obstructive pulmonary disease (COPD). This study examined the effect of AM3 on the quality of life of patients in different risk groups and identified the factors associated with change in this variable., Patients and Method: This was a randomized, double-blind, placebo-controlled trial involving parallel groups of patients. The duration of the trial was 6 months. The study involved 253 patients with a mean (standard deviation) age of 67.7 (8.1) years and a mean forced expiratory volume in one second (FEV1) of 49.7% (10.2%)., Results: Only 121 patients (47.8%) suffered at least one exacerbation during the 6 months period. At the end of the study period, the improvement in St. George's Respiratory Questionnaire (SGRQ) score in those patients who suffered an exacerbation but who received AM3 was significantly greater than that experienced by similar placebo-treated patients (-8.10 compared to -2.5 units; p=0.034). Patients treated with inhaled corticoids also improved more with AM3 than with placebo (-9.17 compared to -4.44; p=0.035). In the 108 patients with an FEV1 of <50%, the improvements were not significantly different (-9.57 vs. -6.57; p=0.23). The factors influencing the change in SGRQ score were baseline SGRQ (p<0.001), exacerbations (p<0.008), an FEV1 of <50% (p<0.032) and treatment with AM3 (p<0.004)., Conclusions: Among the patients who experienced exacerbations, treatment with AM3 helped prevent the deterioration of their quality of life. Along with AM3 treatment, the factors that independently influenced the change in SGRQ score were suffering from an exacerbation and poorer pulmonary function.

Objective: The aim of this study was to determine the impact of chronic obstructive pulmonary disease (COPD) on activities of daily living in a large group of patients in Spain who responded to a specific questionnaire. A second aim was to explore the practical utility of the questionnaire and determine which variables could be used to identify "fragile" patients or patients in greater need of attention. To do this, we examined the relationship between questionnaire results and clinical variables, lung function measurements, socioeconomic status, and validated quality of life questionnaires., Methods: We conducted an observational, descriptive, multicenter, cross-sectional study in which 227 respiratory specialists from all over Spain collected data from 1057 patients with COPD. Each patient was given a specific questionnaire containing 7 items that measured the extent to which COPD affected different aspects of their lives. The patients rated each item on a scale of 0 to 2, depending on the level of impact. Total possible scores, thus, ranged from 0 to 14, and patients with a score of 9 or higher were classified as fragile. We then explored the relationship between questionnaire results and clinical variables, socioeconomic status, spirometric values, and quality of life as measured by the St George's Respiratory Questionnaire (SGRQ)., Results: We studied 1057 patients (95.2% male) with a mean (SD) age of 67 (9) years and a mean predicted forced expiratory volume in 1 second (FEV1) of 41.8% (13.3%). The mean questionnaire score was 6.3 (3.1). The activities that were affected most were sport and leisure, habitual physical activity, and sex life (major impact reported by 52.5%, 30.3%, and 20.2% of patients, respectively). We found a correlation between questionnaire scores and known disease severity markers such as SGRQ scores, dyspnea, number of exacerbations, and FEV1 in liters. Patients included in the fragile category were older and had a lower socioeconomic status., Conclusions: COPD impact questionnaire scores correlated well with SGRQ scores and the usual clinical variables and lung function measurements for evaluating disease severity (dyspnea, FEV1, and exacerbations). The questionnaire could, therefore, be a useful tool for identifying fragile patients who, in addition to having poorer clinical status and lung function measurements, have a lower socioeconomic status.

Background: COPD has a severe impact on patient quality of life. AM3 is an orally effective immunomodulator that can normalize the defective antimicrobial functions of the immune system effector cells of COPD patients., Objectives: We analyzed the effect of AM3 on exacerbation frequency and health-related quality of life (HRQL) of COPD patients with moderate disease., Design: A randomized, double-blind, placebo-controlled trial., Setting: Outpatient departments of 21 hospitals., Methods: A total of 253 COPD patients with a mean age of 67.7 years (SD, 8.1 years) and mean FEV(1) percentage of predicted of 49.6% (SD, 10.2%) were evaluated. Patients received (orally) either 3 g/d AM3 or a matched placebo for 180 consecutive days. Patient quality of life was measured using the St. George's Respiratory Questionnaire (SGRQ)., Results: There were no differences in the exacerbation frequency of the two groups (0.82 episodes per patient in the AM3 arm vs 0.84 in the placebo arm), and 55.3% of patients were exacerbation free in the AM3 arm compared to 48.8% in the placebo arm (p = 0.11). At the end of treatment, quality of life was significantly better in the AM3 arm than in the placebo arm (SGRQ total score, 32.9; SD, 16.4, compared to 37.5; SD, 17.5 [p < 0.05]: activity score, 47.5; SD, 22.4, compared to 54.6; SD, 20.5 [p < 0.05]). The improvements in total SGRQ scores were 8.9 U (SD, 13.4 U) in the AM3 arm and 5.6 U (SD, 15.9 U) in the placebo arm (p = 0.076). Improvements on the symptoms subscale were 15.9 U (SD, 20.7 U) for the AM3 arm and 10.2 U (SD, 21.3 U) for the placebo arm (p < 0.05). Both AM3 and the placebo were clinically, biochemically, and hematologically well tolerated., Conclusions: AM3 is a safe, easily tolerated, effective treatment that improves the quality of life of COPD patients as measured by SGRQ scores. This effect was observed with no significant reduction in the frequency of exacerbations.

There is a lack of emphasis on health-related QOL (HR-QOL) changes associated with acute exacerbation of chronic bronchitis (CB) or chronic obstructive pulmonary disease (COPD). The aim of this review is to examine the use of HR-QOL instruments to evaluate acute exacerbation of CB or COPD, so as to form recommendations for future research.A literature search of papers published between 1966 and July 2003 identified more than 300 articles that used acute exacerbation of CB or COPD as the search term. However, only 21 of these studies employed HR-QOL measures as predictors of outcome or in the assessment of the impact, evolution or treatment of acute exacerbations of COPD or CB. A variety of HR-QOL measures were used, both generic and disease specific. The disease-specific St George's Respiratory Questionnaire (SGRQ), devised for patients with stable CB and with a recall period of 1-12 months, was the most widely used measure, with the Chronic Respiratory disease Questionnaire (CRQ) and the Baseline and Transitional Dyspnoea Index (BDI, TDI) being the only other disease-specific measures used. Most measures, both generic and disease specific, performed adequately when used during acute exacerbation of CB or COPD and indicated poor HR-QOL during acute exacerbation, which improved on resolution of the exacerbation. Relationships were evident between HR-QOL during an acute exacerbation and various outcomes, including post-exacerbation functional status, hospital re- admission for acute exacerbation or COPD, and mortality. There is a need for studies of treatments for acute exacerbation of CB or COPD to include an appropriate HR-QOL instrument to aid in the stratification of patients so as to target the right treatment to the right patient group. While a new instrument could be developed to measure HR-QOL during acute exacerbation of CB or COPD, currently available disease-specific measures such as the CRQ and the SGRQ appear to be acceptable to patients during acute exacerbation. However, the recall period of the SGRQ symptoms component should be shortened to make it more appropriate for use during acute exacerbation.

Dyspnea refers to the sensation of breathlessness, shortness of breath, or difficulty breathing that is commonly observed in patients with respiratory and cardiac disease. In the United States alone, dyspnea is reported in up to 4 million all-cause emergency room visits annually. Dyspnea can be a symptom of several different underlying physical conditions, typically involving the lung and heart. Indeed, it is an important symptom in chronic obstructive pulmonary disease (COPD), where it is associated with limited physical activity, increased anxiety and depression, decreased health-related quality of life (HRQoL), and reduced survival. Currently there is no single physiological correlate that will accurately predict dyspnea, particularly because the mechanisms that contribute to respiratory discomfort can vary between diseases and between individuals experiencing breathlessness who have been diagnosed with the same disease. Therefore, various subjective clinical and psychophysical scales and questionnaires are typically used to measure or predict dyspnea. It is the goal of this review to discuss the pathophysiological mechanisms leading to dyspnea, particularly those associated with COPD, the physical and psychological impact on patients, assessment approaches, and modalities currently used to treat it. [ABSTRACT FROM AUTHOR]

Background: COPD ranks within the top three causes of mortality in the global burden of disease, yet it remains largely underdiagnosed. We assessed the underdiagnosis of COPD and its determinants in national and international surveys of general populations.Methods: We analyzed representative samples of adults aged ≥ 40 years randomly selected from well-defined administrative areas worldwide (44 sites from 27 countries). Postbronchodilator FEV1/FVC < lower limit of normal (LLN) was used to define chronic airflow limitation consistent with COPD. Undiagnosed COPD was considered when participants had postbronchodilator FEV1/FVC < LLN but were not given a diagnosis of COPD.Results: Among 30,874 participants with a mean age of 56 years, 55.8% were women, and 22.9% were current smokers. Population prevalence of (spirometrically defined) COPD ranged from 3.6% in Barranquilla, Colombia, to 19.0% in Cape Town, South Africa. Only 26.4% reported a previous lung function test, and only 5.0% reported a previous diagnosis of COPD, whereas 9.7% had a postbronchodilator FEV1/FVC < LLN. Overall, 81.4% of (spirometrically defined) COPD cases were undiagnosed, with the highest rate in Ile-Ife, Nigeria (98.3%) and the lowest rate in Lexington, Kentucky (50.0%). In multivariate analysis, a greater probability of underdiagnosis of COPD was associated with male sex, younger age, never and current smoking, lower education, no previous spirometry, and less severe airflow limitation.Conclusions: Even with substantial heterogeneity in COPD prevalence, COPD underdiagnosis is universally high. Because effective management strategies are available for COPD, spirometry can help in the diagnosis of COPD at a stage when treatment will lead to better outcomes and improved quality of life. [ABSTRACT FROM AUTHOR]

Patients with chronic obstructive pulmonary disease (COPD) may experience variability in symptoms during the day, even in periods of stability. Morning is the most troublesome time of the day for the majority of patients, complicating the performance of daily activities and resulting in a substantial impact on quality of life. Morning symptoms are related to the severity of the disease and are the cause of high worker absenteeism and increased economic burden. Patient-reported outcome (PRO) questionnaires have been developed to identify this variability in symptoms and to evaluate the impact of the disease in patients' lives. Several PRO questionnaires have already been used to assess the effect of therapeutic interventions on symptoms in the morning, such as the Capacity of Daily Living during the Morning (CDML) and the Global Chest Symptoms Questionnaire (GCSQ), both of which have been validated in clinical trials. Results of pharmacological trials indicate that the use of a bronchodilator with a fast onset of action produces a signiicant improvement in respiratory symptoms in the morning. Glycopyrronium bromide, a once-daily, long- acting muscarinic antagonist (LAMA), is selective for human M3 and M1 receptors over the M2 receptor . Receptor kinetics showing more rapid equilibration with the M3 receptor for glycopyrronium bromide than for tiotropium bromide may be the reason for the difference in onset of the bronchodilator effect. Glycopyrronium bromide's rapid onset of action may reduce the frequency and intensity of morning symptoms in COPD. [ABSTRACT FROM AUTHOR]

Chronic obstructive pulmonary disease (COPD) symptoms in the morning, including dyspnea and sputum production, affect patients' quality of life and limit their ability to carry out even simple morning activities. It is now emerging that these symptoms are associated with increased risk of exacerbations and work absenteeism, suggesting that they have a more profound impact on patients than previously thought. The development of validated patient-reported outcome (PRO) questionnaires to capture patients' experience of COPD symptoms in the morning is, therefore, vital for establishing effective and comprehensive management strategies. Although it is well established that long-acting bronchodilators are effective in improving COPD symptoms, the limited available data on their impact on morning symptoms and activities have been obtained with non-validated PRO questionnaires. In this review, we discuss the impact of COPD symptoms in the morning and available tools used to evaluate them, and highlight specific gaps that need to be addressed to develop standardized instruments able to meet regulatory requirement. We also present available evidence on the effect of pharmacological therapies on morning symptoms. [ABSTRACT FROM AUTHOR]

Background: The Living with COPD (LCOPD), COPD and Asthma Fatigue Scale (CAFS), and COPD and Asthma Sleep Impact Scale (CASIS) are instruments developed to assess the overall impact of chronic obstructive pulmonary disease (COPD) on daily life, fatigue, and sleep impairment, respectively. Objectives: To assess the usefulness of these instruments and to identify factors associated with the concepts they measure. Method: The questionnaires were administered to patients with moderate to severe COPD. Descriptive analyses of sociodemographic and clinical data were performed, and bivariate and multivariate analyses were used to identify factors associated with the overall impact of COPD on patients' lives, fatigue, and sleep impairment. Results: A total of 408 patients was included (mostly males, 91.2%), with an average age of 68 years (SD = 9.3). Statistically significant differences were observed in the scores of the three questionnaires with regard to level of education, presence of chronic cough or expectoration, level of dyspnea, number of exacerbations, physical activity level, presence of depression and anxiety, and number of treatments indicated for COPD. The LCOPD and CAFS questionnaires also discriminated between different levels of airflow obstruction and, in the case of CAFS, age and gender. Linear regression showed that level of dyspnea, physical activity, and presence of anxiety were significantly related to the LCOPD, CAFS and CASIS scores. The presence of depression was significant in the LCOPD and CAFS questionnaires and chronic cough was significant in the CAFS questionnaire. Conclusions: The LCOPD, CAFS, and CASIS instruments are valid and useful in understanding the overall impact of COPD on daily life, fatigue, and sleep impairment in patients with moderate to severe COPD. Copyright © 2012 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Background and objective The best strategy to achieve optimal integrated management to patients with chronic obstructive pulmonary disease ( COPD) in primary care ( PC) is not clear. We aimed to evaluate the effectiveness of an intervention in PC based on an integrated programme, which combines diverse strategies directed at health professionals to improve quality of life and clinical outcomes of their patients with COPD. We compared the outcome with results from standard practice. Methods A prospective, multicentre, quasi-experimental study and a 12-month follow up was performed. Intervention consisted of an integrated education programme in PC. The main outcome variable was the change in total score of the St. George's Respiratory Questionnaire ( SGRQ) at the end of follow up between the control and intervention group. Results A total of 801 patients participated in the study with a mean age of 70.2 years and a mean FEV1 (% predicted) of 55%. At 1-year follow up, the SGRQ score did not significantly differ. Although the intervention group showed an improvement in dietary, exercise and smoking habits, there was an increase in reported exacerbations and hospital admissions ( P < 0.001). Conclusions Implementation of an integrated education programme in a PC setting, which combines diverse strategies directed at health professionals, did not achieve the expected changes in quality of life measured by SGRQ at 1-year follow up. Nonetheless, this study observed an improvement in patients' lifestyle choices, even though this did not result in a significant change in the clinical evolution or heath status over 12 months. [ABSTRACT FROM AUTHOR]

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Background: Elevated circulating levels of several inflammatory biomarkers have been described in selected patient populations with COPD, although less is known about their population-based distribution. The aims of this study were to compare the levels of several systemic biomarkers between stable COPD patients and healthy subjects from a population-based sample, and to assess their distribution according to clinical variables. Methods: This is a cross-sectional study design of participants in the EPI-SCAN study (40-80 years of age). Subjects with any other condition associated with an inflammatory process were excluded. COPD was defined as a postbronchodilator FEV1/FVC < 0.70. The reference group was made of non-COPD subjects without respiratory symptoms, associated diseases or prescription of medication. Subjects were evaluated with quality-of-life questionnaires, spirometry and 6-minute walk tests. Serum C-reactive protein (CRP), tumor necrosis factor (TNF)-α, interleukins (IL-6 and IL-8), alpha1-antitrypsin, fibrinogen, albumin and nitrites/nitrates (NOx) were measured. Results: We compared 324 COPD patients and 110 reference subjects. After adjusting for gender, age, BMI and tobacco consumption, COPD patients showed higher levels of CRP (0.477 ± 0.023 vs. 0.376 ± 0.041 log mg/L, p = 0.049), TNF-a (13.12 ± 0.59 vs. 10.47 ± 1.06 pg/mL, p = 0.033), IL-8 (7.56 ± 0.63 vs. 3.57 ± 1.13 pg/ml; p = 0.033) and NOx (1.42 ± 0.01 vs. 1.36 ± 0.02 log nmol/l; p = 0.048) than controls. In COPD patients, serum concentrations of some biomarkers were related to severity and their exercise tolerance was related to serum concentrations of CRP, IL-6, IL-8, fibrinogen and albumin. Conclusions: Our results provide population-based evidence that COPD is independently associated with low-grade systemic inflammation, with a different inflammatory pattern than that observed in healthy subjects. [ABSTRACT FROM AUTHOR]

Objective: The GIANT study collected information on patients with acute exacerbations of chronic bronchitis (AECB) and chronic obstructive pulmonary disease (COPD) and the effect of treatment with moxifloxacin.Methods: AECB history, concomitant diseases, moxifloxacin treatment, concomitant medication, clinical symptoms and adverse events were recorded. A questionnaire at the end of treatment recorded the impact on patients’ daily lives.Results: Among 9225 patients from eight European countries, marked variation was seen in characteristics including age, smoking history and type of exacerbation. Spirometry use was more common among chest physicians (66.7%) than GPs (15.5%). Patients with Anthonisen type 1 and 2 exacerbations had more frequent exacerbations and these patients experienced a greater impact on daily activities compared with patients with type 3 episodes. Patient symptoms improved with moxifloxacin treatment after a mean (SD) of 3.4 (1.8) days, allowing return to normal daily activities after 5.4 (4.4) days and with full recovery taking 6.5 (3.1) days.Conclusions: Characteristics of patients with AECB and acute exacerbations of COPD differ among European countries. Spirometry is under-used, particularly in primary care and antibiotic treatment does not always follow current guidelines. Results confirm the efficacy of moxifloxacin in the treatment of AECB in real-life conditions. [ABSTRACT FROM PUBLISHER]

Large, multicenter, randomized controlled trials in COPD have recently been completed. The largest of these studies are "Towards a Revolution in COPD Health" (TORCH) and "Understanding Potential Long-Term Impacts on Function with Tiotropium" (UPLIFT®). These studies make considerable contributions to understanding the natural history of COPD. The objective of this article is to review the data from these different trials in order to find what can be learnt of the management of COPD. The long-term improvements in lung function, health-related quality of life, and possibly survival from the use of long-acting bronchodilators in these trials suggest an influence on the progression of the disease. [ABSTRACT FROM AUTHOR]

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Objectives: To describe the health-related quality of life (HRQL) in a cohort of COPD patients recruited in primary care and identify the variables of the patients and the treatment associated with impaired HRQL.Method: Multicenter, observational study of patients with COPD recruited in Primary Care centers. Data regarding HRQL measured by the St. George's respiratory questionnaire (SGRQ) are presented. The total population was divided into two subgroups, high and Low SGRQ, using the median of the total SGRQ score. Univariate analysis and logistic regression analysis with calculation of adjusted odds ratios were used to investigate the factors significantly associated with a higher SGRQ score (poor HRQL).Results: A total of 27 investigators included 222 valid patients with a mean age of 68.2 years (SD = 9.9) and a mean FEV1(%) of 49.2% (SD = 15.4%). The median total SGRQ score was 39.5 and patients with a high score had a longer evolution of COPD (p < 0.0001), more severe dyspnea (p < 0.0001) and a worse FEV1(%) (46.3% vs. 51.9%; p = 0.008). Factors independently associated with the total SGRQ score were cough and dyspnea, duration of COPD and treatment with inhaled steroids.Conclusion: Patients with COPD controlled in primary care demonstrate an important impairment in HRQL, with chronic cough and dyspnea being associated with more impaired HRQL. Strategies aimed at modifying these factors should significantly improve the well-being of COPD patients. [ABSTRACT FROM PUBLISHER]

Copyright of Archivos de Bronconeumología (English Edition) is the property of Sociedad Espanola de Neumologia y Cirugia Toracica (SEPAR) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)