COPD clinical control as a predictor of future exacerbations: concept validation in the SPARK study population.

The concept of chronic obstructive pulmonary disease (COPD) control has been proposed to guide treatment decisions in COPD. In this study, we aimed to validate the prospective value of this concept in the SPARK study population. Control was assessed based on COPD stability and impact. Patients with low impact and stability during weeks 1-12 were classified as controlled, and exacerbations were measured during a 52-week follow-up. Of the 2044 patients included a majority were non-controlled (80%), frequently due to high impact. During the follow-up, the rate of moderate/severe exacerbations was significantly lower in controlled patients (rate ratio, 0.56, 95% CI 0.48 to 0.65 p<0.0001) and time-to-first moderate/severe exacerbation was significantly delayed. This study demonstrated an association between control status and risk of exacerbations.

Predictive value of control of COPD for risk of exacerbations: An international, prospective study.

BACKGROUND AND OBJECTIVE: The concept of clinical control in COPD has been developed to help in treatment decisions, but it requires validation in prospective studies. METHODS: This international, multicentre, prospective study aimed to validate the concept of control in COPD. Patients with COPD were classified as controlled/uncontrolled by clinical criteria or CAT scores at baseline and followed up for 18 months. The main outcome was the difference in rate of a composite endpoint of moderate and severe exacerbations or death over the 18-month follow-up period. RESULTS: A total of 307 patients were analysed (mean age = 68.6 years and mean FEV1 % = 52.5%). Up to 65% and 37.9% of patients were classified as controlled by clinical criteria or CAT, respectively. Controlled patients had significantly less exacerbations during follow-up (by clinical criteria: 1.1 vs 2.6, P < 0.001; by CAT: 1.1 vs 1.9, P = 0.014). Time to first exacerbation was significantly prolonged for patients controlled by clinical criteria only (median: 93 days, IQR: 63; 242 vs 274 days, IQR: 221; 497 days; P < 0.001). Control status by clinical criteria was a better predictor of exacerbations compared to CAT criteria (AUC: 0.67 vs 0.57). CONCLUSION: Control status, defined by easy-to-obtain clinical criteria, is predictive of future exacerbation risk and time to the next exacerbation. The concept of control can be used in clinical practice at each clinical visit as a complement to the current recommendations of initial treatment proposed by guidelines.

Factors affecting the selection of an inhaler device for COPD and the ideal device for different patient profiles. Results of EPOCA Delphi consensus.

BACKGROUND: This study aimed to identify the relevant factors for the choice of an inhaler device by physicians and the selection of the most important characteristics of a device according to different characteristics of patients with COPD. METHOD: In this two-round Delphi survey, 96 Spanish COPD-expert pulmonologists completed an internet-based, self-administered questionnaire, which consisted of a first part with 19 items related to the prioritization of the drug or the device, the experience, ability and preference of the patient, and the experience and preferences of the healthcare professional. For each item, responses were grouped into three categories based on a 9-point Likert-type scale, calculating the response frequency and the degree of consensus. The second part included 18 items related to the inhalation devices with the aim to identify the main characteristics of a device for 8 different profiles of patients with COPD. RESULTS: Experts considered that the selection of a device was relevant when choosing the treatment for COPD patients, although 62.5% of them prioritised the selection of the drug over the device. The experience of the patient (89.6%) and his/her ability to handle the device (97.9%), together with coordination (96.9%), ability to learn (87.5%) and adherence to therapy (84.4%) were the main aspects considered in the selection of inhalation device. The panel identified Respimat® as the most adequate device for patients with either low inspiratory flow or severely impaired lung function and Spiromax® for patients with either impaired fine motor skills or older than 70 years. CONCLUSIONS: Selection of the inhalation device is recognized by specialists as a strategic therapeutic decision and should be based on the characteristics of the individual patient. Some devices may be more adequate for different patient profiles.

Validating the Concept of COPD Control: A Real-world Cohort Study from the United Kingdom.

The concept of Chronic Obstructive Pulmonary Disease (COPD) control has been developed to inform therapeutic decision-making. We explored the validity of a definition of COPD control in a representative population of patients with COPD in the United Kingdom. Electronic medical records and linked COPD questionnaire data from the Optimum Patient Care Research Database were used to characterize control status. Patients were aged ≥40 years, with spirometry-confirmed COPD, current or ex-smokers, and continuous records throughout the study period. Control was evaluated based on COPD stability and patients' (i) clinical features or (ii) COPD Assessment Test (CAT) score over a three-month baseline period and linked to time to first exacerbation. Of 2788 eligible patients, 2511 (90%) had mild/moderate COPD and 277 (10%) had severe/very severe COPD based on Body Mass Index, Obstruction, Dyspnoea, Exacerbations (BODEx) cut-off of 4. Within the mild/moderate cohort, 4.5% of patients were controlled at baseline according to clinical features and 21.5% according to CAT threshold of 10. Within the severe/very severe cohort, no patients were controlled at baseline according to the proposed clinical features and 8.3% were controlled according to CAT threshold of 20. Compared with uncontrolled patients, time to first exacerbation was longer for controlled patients with mild/moderate COPD but not for those with severe/very severe COPD. Lowering the BODEx threshold for severity classification to 2 increased the number of patients achieving control. CAT scores were not good predictors of the risk of future exacerbation. With the proposed definition, very few patients were defined as controlled.

Requirements, Strengths and Weaknesses of Inhaler Devices for COPD Patients from the Expert Prescribers' Point of View: Results of the EPOCA Delphi Consensus.

The study aimed to assess the preferences of expert physicians about the requirements for inhalation devices for patients with chronic obstructive pulmonary disease (COPD) and to identify the most relevant advantages and disadvantages to their prescription. In a two-round Delphi survey, 96 Spanish COPD-expert pulmonologists completed an internet-based questionnaire to evaluate the degree of importance of the characteristics of the inhaler devices in their choice for COPD. The requirements needed for use in COPD were that the device permits a high pulmonary deposit of the drug, allowed its dispensation at low inspiratory flows, did not require hand-mouth coordination, generated an exact and reproducible dose, its operation was easy to teach, provided the perception of a correct inhalation, had an intuitive use mechanism and security mechanisms to prevent overdosing and generates a reduced oropharyngeal deposit (very good consensus). Modulite®, Respimat® and NEXThaler® were associated with high pulmonary deposit, and Respimat® showed correct dispensation at low inspiratory flows. All dry-powder inhaler devices were associated with the advantage of not requiring coordination, and Respimat® was the only device considered as difficult to teach by more than 50% of the experts. Breezhaler® and Genuair® were positively associated with patients' awareness of correct inhalation, whereas Spiromax® stood out for its intuitive use mechanism. In conclusion, our study contributes to defining the inhaler device properties required for their use in patients with COPD, and to identify the devices that, in the opinion of experts, best meet each requirement.

The evaluation of a remote support program on quality of life and evolution of disease in COPD patients with frequent exacerbations.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) patients often present considerable individual medical burden in their symptoms, limitations, and well-being that complicate medical treatment. To improve their overall health status, while reducing the number of exacerbations, a multidisciplinary approach including different elements of care is needed. The aim of this study was to evaluate the effects of a remote support program on COPD patients at high risk of experiencing worsening of their disease and other health-related outcomes. METHODS: An observational, multicenter, prospective study aimed at evaluating the impact of a 7-month remote support program on COPD patients in exacerbations control and changes in health status measured with the COPD assessment test (CAT). Factors associated with a clinically relevant decrease in CAT were assessed using a logistic regression analysis. RESULTS: A total of 114 subjects started the program. The majority of the study population were males (81.6 %), retired (70.2 %), without academic qualifications or with a low level of education (68.4 %), and ex-smokers (79.8 %). The mean ± SD age was 69.6 ± 9.1 years and the BMI was 27.8 ± 5.5 Kg/m2. Overall, 41.9 % (95 % CI 31.9-52.0) patients, significantly improved health status (CAT decrease ≥ 2 points). Univariate analysis showed that significant improvement in CAT was associated with baseline CAT scores [high CAT score 19.2 (±7.5) vs. low CAT score 12.4 (±6.4); OR = 1.15, 95 % CI: 1.07-1.24; p < 0.001] and with being non-compliant [62.5 % (15/24) of non-compliant vs 34.7 % (24/69) of compliant patients significantly improved CAT scores; OR = 3.13, 95 % CI: 1.19-8.19; p = 0.021). After controlling for the effect of all variables in a multivariable logistic regression model, the only factor that remained significant was baseline CAT score. The proportion of smokers in the total population remained constant during the study. There was a significant reduction in the number of exacerbations after entering this remote support program with median -1 (IQR: -2, 0), (p < 0.001). The Morisky-Green questionnaire showed an increase of treatment compliance, namely at baseline, 25.8 % (24/93) of patients were noncompliant while in the end 66.7 % (16/24) of them became compliant) (p = 0.053). CONCLUSIONS: A remote support program for high-risk COPD patients results in an improvement of the patients' health status, particularly in those with initially poor health status, and it helps to reduce COPD exacerbations.

Generic utilities in chronic obstructive pulmonary disease patients stratified according to different staging systems.

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.

Repeated Aspergillus isolation in respiratory samples from non-immunocompromised patients not selected based on clinical diagnoses: colonisation or infection?

BACKGROUND: Isolation of Aspergillus from lower respiratory samples is associated with colonisation in high percentage of cases, making it of unclear significance. This study explored factors associated with diagnosis (infection vs. colonisation), treatment (administration or not of antifungals) and prognosis (mortality) in non-transplant/non-neutropenic patients showing repeated isolation of Aspergillus from lower respiratory samples. METHODS: Records of adult patients (29 Spanish hospitals) presenting ≥ 2 respiratory cultures yielding Aspergillus were retrospectively reviewed and categorised as proven (histopathological confirmation) or probable aspergillosis (new respiratory signs/symptoms with suggestive chest imaging) or colonisation (symptoms not attributable to Aspergillus without dyspnoea exacerbation, bronchospasm or new infiltrates). Logistic regression models (step-wise) were performed using Aspergillosis (probable + proven), antifungal treatment and mortality as dependent variables. Significant (p < 0.001) models showing the highest R2 were considered. RESULTS: A total of 245 patients were identified, 139 (56.7%) with Aspergillosis. Aspergillosis was associated (R2 = 0.291) with ICU admission (OR = 2.82), congestive heart failure (OR = 2.39) and steroids pre-admission (OR = 2.19) as well as with cavitations in X-ray/CT scan (OR = 10.68), radiological worsening (OR = 5.22) and COPD exacerbations/need for O2 interaction (OR = 3.52). Antifungals were administered to 79.1% patients with Aspergillosis (100% proven, 76.8% probable) and 29.2% colonised, with 69.5% patients receiving voriconazole alone or in combination. In colonised patients, administration of antifungals was associated with ICU admission at hospitalisation (OR = 12.38). In Aspergillosis patients its administration was positively associated (R(2) = 0.312) with bronchospasm (OR = 9.21) and days in ICU (OR = 1.82) and negatively with Gold III + IV (OR = 0.26), stroke (OR = 0.024) and quinolone treatment (OR = 0.29). Mortality was 78.6% in proven, 41.6% in probable and 12.3% in colonised patients, and was positively associated in Aspergillosis patients (R2 = 0.290) with radiological worsening (OR = 3.04), APACHE-II (OR = 1.09) and number of antibiotics for treatment (OR = 1.51) and negatively with species other than A. fumigatus (OR = 0.14) and aspergillar tracheobronchitis (OR = 0.27). CONCLUSIONS: Administration of antifungals was not always closely linked to the diagnostic categorisation (colonisation vs. Aspergillosis), being negatively associated with severe COPD (GOLD III + IV) and concomitant treatment with quinolones in patients with Aspergillosis, probably due to the similarity of signs/symptoms between this entity and pulmonary bacterial infections.

Use of Antivirals in SARS-CoV-2 Infection. Critical Review of the Role of Remdesivir.

The aim of this report is to review the literature and shed light on the uncertainties surrounding the use of antiviral agents in general and remdesivir in COVID-19 patients. This review evaluated a battery of antiviral compounds and their effectiveness in the treatment of COVID-19 since the beginning of the pandemic. Remdesivir is the only antiviral approved by the EMA and FDA for the treatment of SARS-CoV-2 infection. This work extensively reviews remdesivir data generated from clinical trials and observational studies, paying attention to the most recent data, and focusing on outcomes to give readers a more comprehensive understanding of the results. This review also discusses the recommendations issued by official bodies during the pandemic in the light of the current knowledge. The use of remdesivir in the treatment of SARS-CoV-2 infection is justified because a virus is the causative agent that triggers the inflammatory responses and its consequences. More trials are needed to improve the management of this disease.

Pulmonologists' Opinion on the Use of Inhaled Corticosteroids in Chronic Obstructive Pulmonary Disease Patients in Spain: A Cross-Sectional Survey.

Introduction: Identifying the variables that guide decision-making in relation to the use of inhaled corticosteroids (ICS) can contribute to the appropriate use of these drugs. The objective of this study was to identify the clinical variables that physicians consider most relevant for prescribing or withdrawing ICS in COPD. Methods: A cross-sectional survey was conducted in Spain from November 2020 to May 2021. Therapeutic decisions on the use of ICS in 11 hypothetical COPD patient profiles were collected using an online survey answered by specialists with experience in the management of patients with COPD. Mixed-effects logistic regression was used to analyze the impact of patients' characteristics in the therapeutic decision for prescribing ICS or proceeding to its withdrawal. Results: A total of 74 pulmonologists agreed to collaborate in the survey and answered the questionnaire. The results showed great variability, with only 2 profiles achieving consensus for starting or withdrawing the treatment. The frequency and severity of exacerbations influenced the decision to prescribe ICS in a dose-response fashion (1 exacerbation odds ratio (OR) = 1.86, 95% confidence interval (CI) 1.02 to 3.43, two exacerbations OR = 11.6, 95% CI: 4.47 to 30.2 and three OR = 123, 95% CI: 25 to 601). Similarly, increasing blood eosinophils and history of asthma were associated with ICS use. On the other hand, pneumonia reduced the probability of initiating treatment with ICS (OR = 0.54 [0.29 to 0.98]). Lung function and dyspnea degree did not influence the clinician's therapeutic decision. The results for withdrawal of ICS were similar but in the opposite direction. Conclusion: In accordance with guidelines, exacerbations, blood eosinophils and history of asthma or pneumonia are the factors considered by pulmonologist for the indication or withdrawal of ICS. However, the agreement in prescription or withdrawal of ICS when confronted with hypothetical cases is very low, suggesting a great variability in clinical practice.

Blood Eosinophil Counts and Their Variability and Risk of Exacerbations in COPD: A Population-Based Study.

BACKGROUND: There is controversy regarding the role of blood eosinophil levels as a biomarker of exacerbation risk in chronic obstructive pulmonary disease (COPD). Our aim was to quantify blood eosinophil levels and determine the risk of exacerbations associated with these levels and their variability. METHODS: Observational, retrospective, population-based study with longitudinal follow-up in patients with COPD identified in a primary care electronic medical record database in Catalonia, Spain, covering 80% of the general population. Patients were classified into 4 groups using the following cut-offs: (a) <150cells/µl; (b) ≥150 and <300cells/µl; (c) ≥300 and <500cells/µl; (d) ≥500cells/µl. RESULTS: A total of 57,209 patients were identified with a mean age of 70.2 years, a mean FEV1(% predicted) of 64.1% and 51.6% had at least one exacerbation the previous year. The number of exacerbations in the previous year was higher in patients with the lowest and the highest eosinophil levels compared with the intermediate groups. During follow-up the number of exacerbations was slightly higher in the group with the lowest blood eosinophil levels and in those with higher variability in eosinophil counts, but ROC curves did not identify a reliable threshold of blood eosinophilia to discriminate an increased risk of exacerbations. CONCLUSIONS: Our results do not support the use of blood eosinophil count as a reliable biomarker of the risk of exacerbation in COPD in a predominantly non-exacerbating population. Of note was that the small group of patients with the highest variability in blood eosinophils more frequently presented exacerbations.

Changes in Control Status of COPD Over Time and Their Consequences: A Prospective International Study.

INTRODUCTION: Control status may be a useful tool to assess response to treatment at each clinical visit in COPD. Control status has demonstrated to have long-term predictive value for exacerbations, but there is no information about the short-term predictive value of the lack of control and changes in control status over time. METHOD: Prospective, international, multicenter study aimed at describing the short-term (6 months) prognostic value of control status in patients with COPD. Patients with COPD were classified as controlled/uncontrolled at baseline and at 3,6-month follow-up visits using previously validated criteria of control. Moderate and severe exacerbation rates were compared between controlled and uncontrolled visits and between patients persistently controlled, uncontrolled and those changing control status over follow-up. RESULTS: A total of 267 patients were analyzed: 80 (29.8%) were persistently controlled, 43 (16%) persistently uncontrolled and 144 (53.7%) changed control status during follow-up. Persistently controlled patients were more frequently men, with lower (not increased) body mass index and higher FEV1(%). During the 6 months following an uncontrolled patient visit the odds ratio (OR) for presenting a moderate exacerbation was 3.41 (95% confidence interval (CI) 2.47-4.69) and OR=4.25 (95%CI 2.48-7.27) for hospitalization compared with a controlled patient visit. CONCLUSIONS: Evaluation of control status at each clinical visit provides relevant prognostic information about the risk of exacerbation in the next 6 months. Lack of control is a warning signal that should prompt investigation and action in order to achieve control status.

Evaluation of Changes in Control Status in COPD: An Opportunity for Early Intervention.

BACKGROUND: Control has been proposed as a dynamic tool that can capture changes in the clinical status of patients with COPD. METHODS: This prospective, multicenter, observational study aimed to compare changes in control over a 3-month period with changes in risk level, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage, and clinical phenotype (nonexacerbator, asthma-COPD overlap, or exacerbator with emphysema or with chronic bronchitis). Control was defined as the presence of low clinical impact, assessed according to the degree of dyspnea, use of rescue medication, physical activity and sputum color, and clinical stability assessed by clinical changes and exacerbations in the last 3 months. Impact and stability were alternatively assessed with COPD Assessment Test (CAT) scores. RESULTS: We included 354 patients, with a mean FEV1 of 49.8% ± 16.9%. At 3 months, the proportion of controlled patients was 50.3% according to clinical evaluation and 47.8% according to CAT score. Eighty-seven patients (29.2%) changed their control status as assessed by clinical variables, and 85 patients (28.5%) changed their status according to CAT score. In contrast, the risk level only changed in 26 patients (8.7%) (P < .001), 27 patients (9.1%) experienced changes in their clinical phenotype (P < .001), and 59 patients (19.8%) experienced changes in their GOLD stage (P = .008). Patients who showed an improvement in control status had better CAT scores at the end of follow-up (P < .001). CONCLUSIONS: In only 3 months, almost one-third of patients experienced changes in their control status. Changes in control status were significantly more frequent than changes in phenotype, risk level, and GOLD stage, and resulted in significant changes in health status.

[Telephone Support for Copd Patients During COVID-19]. / Soporte telefónico al paciente con EPOC en tiempos de la COVID-19.

The state of alarm declared by the Spanish government as the main measure for preventing contagion has involved a change in the clinical management of chronic patients. Although new communication technologies offer us many ways to establish direct but remote contact, the peculiarities of the COPD patient often mean that their healthcare is reduced to telephone calls. The challenge of caring for COPD patients is made even more complex when it has to be delivered over the phone. The interview must be conducted without examining the patient, without performing additional tests, and without checking their inhalation technique. Therefore, healthcare providers who conduct these interviews must be trained to perform them properly in order to make the right decisions. This document is aimed at healthcare professionals who need to provide some form of telephone care to COPD patients during the SARS-CoV-2 pandemic and is based on the authors' experience in telephone interviews conducted during this period. It summarizes essential aspects of how this interview should be approached, how to conduct it, what factors should be kept in mind, how to organize the interview, and how to keep patients informed. It is very likely that from now on this type of interview will be common practice in the care of our patients, so we need to learn how to structure a new model of healthcare for many of the clinical visits that have until now been conducted face-to-face.

Comparison of clinical baseline characteristics between Asian and Western COPD patients in a prospective, international, multicenter study.

We aimed to compare clinical characteristics between Asian and Western chronic obstructive pulmonary disease (COPD) patients. This was a sub-analysis of an international, multicenter, prospective cohort study. Asian patients were enrolled in Singapore and South Korea. Western patients were enrolled in Spain, Poland, Ireland, the United Kingdom, and Malta. A total of 349 patients were analyzed. Among them, 110 (32%) patients were Asian and 239 (68%) Western. Male sex was more predominant in Asian than in Western (95% versus 63%, respectively; P<0.01). Body mass index was significantly lower in Asian (23.5 versus 27.1; P<0.01). The proportion of patients with a history of exacerbation was lower in Asian (12% versus 64%; P<0.01). Although patients were enrolled by same inclusion criteria, there were several differences between Asian and Western COPD patients. Our study has shown unbiased real-world differences between Asian and Western COPD patients. Since prospective follow-up study is currently ongoing, the result of this study can be fundamental base of future analysis.

Validation of clinical control in COPD as a new tool for optimizing treatment.

BACKGROUND: It has recently been proposed that the concept of clinical control in COPD may be useful for deciding treatment in COPD, but the original control criteria (OCC) were considered too restrictive. OBJECTIVE: Define and subsequently validate "modified" control criteria (MCC) of COPD. METHOD: Prospective observational study in COPD patients with a 1-year follow-up. Control was defined as the presence of low clinical impact and clinical stability. To evaluate clinical impact, the following clinical parameters were assessed: the degree of dyspnea, use of rescue medication, physical activity, and sputum color. Stability was assessed by clinical changes and exacerbations in the last 3 months. The COPD assessment test score and their changes were also evaluated as alternative control criteria. To define the MCC, adjustment for disease severity using BODEx index (MCC-B) or FEV1 (MCC-F) was evaluated, and the best cutoff point was established. Time to first combined event (emergency visit, hospitalization, or death) was analyzed to evaluate the predictive capacity of risk of the OCC, MCC-B, and MCC-F. RESULTS: We included 265 patients, 224 (83.9%) men, with a mean age (±SD) of 68±9 years and FEV1 of 58%±17%. The proportion of controlled patients was higher using clinical MCC-B or MCC-F (61.5% and 59.6%) than OCC (27.5%). Similar percentages were found using COPD assessment test scores. The time to the first combined event was significantly greater in controlled patients using MCC criteria (P<0.001, all cases). The predictive capacity of risk was similar in MCC-B (c-statistic [C]=0.639) and MCC-F (C=0.637) and higher than OCC (C=0.589). CONCLUSIONS: The new MCC identified a higher number of controlled COPD patients. These patients have a better quality of life and lower risk of poor outcomes. The concept of control and the new MCC could be a useful tool to optimize therapy.

Evaluation of criteria for clinical control in a prospective, international, multicenter study of patients with COPD.

BACKGROUND: The concept of clinical control in COPD has been developed to help in treatment decisions, but it requires validation in prospective studies. METHOD: This international, multicenter, prospective study aimed to validate the concept of control in COPD [control = stability (no exacerbations or impairment in CAT scores) + low impact (low level of symptoms)]. Data from the screening visit was used to: investigate the level of control, compare characteristics of patients according to the control status, and perform a sensitivity analysis of the levels of control using either clinical criteria or questionnaires (COPD Assessment Test -CAT- or Clinical COPD Questionnaire -CCQ-). RESULTS: A total of 314 patients were analysed, mean age was 68.5 years and mean FEV1 was 52.6% of predicted. According to the prespecified criteria 21% of patients were classified as controlled, all of them with mild/moderate COPD (Body mass index, Obstruction, Dyspnea and Exacerbations, -BODEx-index <5). A high level of dyspnea, a high CAT score or an exacerbation in the previous 3 months were found, using univariate analysis, to be the main reasons for patients not being classified as controlled. Multivariate analysis showed that female sex, chronic bronchitis and having exacerbations in the previous year were associated with uncontrolled COPD. Changing the severity cut off of BODEx from 5 to 3 did not change significantly the percentage of patients fulfilling the criteria of control. CONCLUSIONS: The proposed criteria of control were only fulfilled by 21% of patients. The suggested cut offs and their predictive value for poor outcomes need to be refined in prospective studies.

Active smoking and COPD phenotype: distribution and impact on prognostic factors.

PURPOSE: Smoking can affect both the phenotypic expression of COPD and factors such as disease severity, quality of life, and comorbidities. Our objective was to evaluate if the impact of active smoking on these factors varies according to the disease phenotype. PATIENTS AND METHODS: This was a Spanish, observational, cross-sectional, multicenter study of patients with a diagnosis of COPD. Smoking rates were described among four different phenotypes (non-exacerbators, asthma-COPD overlap syndrome [ACOS], exacerbators with emphysema, and exacerbators with chronic bronchitis), and correlated with disease severity (body mass index, obstruction, dyspnea and exacerbations [BODEx] index and dyspnea grade), quality of life according to the COPD assessment test (CAT), and presence of comorbidities, according to phenotypic expression. RESULTS: In total, 1,610 patients were recruited, of whom 46.70% were classified as non-exacerbators, 14.53% as ACOS, 16.37% as exacerbators with emphysema, and 22.40% as exacerbators with chronic bronchitis. Smokers were predominant in the latter 2 groups (58.91% and 57.67%, respectively, P=0.03). Active smoking was significantly associated with better quality of life and a higher dyspnea grade, although differences were observed depending on clinical phenotype. CONCLUSION: Active smoking is more common among exacerbator phenotypes and appears to affect quality of life and dyspnea grade differently, depending on the clinical expression of the disease.

Expert Statement on the Single-Agent Use of Inhaled Bronchodilator in the Treatment of Stable Mild-Moderate Chronic Obstructive Pulmonary Disease. / Documento de expertos del uso de broncodilatadores inhalados en monoterapia en el tratamiento de la EPOC estable leve-moderada.

OBJECTIVE: To describe the evidence- and experience-based expert consensus on the use of single-agent bronchodilators in patients with stable mild-moderate chronic obstructive pulmonary disease (COPD). METHODS: Using Delphi methodology, a panel of 7 respiratory medicine experts was established, who, in the first nominal group meeting defined the scope, users, and document sections. The panel drew up 14 questions on the use of single-agent bronchodilators in patients with mild-moderate stable COPD to be answered with a systematic review of the literature. The results of the review were discussed in a second nominal group meeting and 17 statements were generated. Agreement/disagreement with the statements was tested among16 different experts including respiratory medicine experts and primary care physicians. Statements were scored from1 (total disagreement) to10 (total agreement). Agreement was considered if at least 70% voted ≥7. The level of evidence and grade of recommendation of the systematic literature review was assessed using the Oxford Centre for Evidence-based Medicine levels. RESULTS: A total of 12 of the 17 statements were selected. Specific statements were generated on different profiles of patients with stable mild-moderate COPD in whom single-agent bronchodilators could be prescribed. CONCLUSIONS: These statements on the use of single-agent bronchodilators might improve the outcomes and prognosis of patients with stable mild-moderate COPD.