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Glycopyrronium (GLY) is a pharmacological maintenance treatment for chronic obstructive pulmonary disease (COPD). However, its effectiveness and tolerability for COPD patients in routine clinical practice have not been well-investigated. This study aimed to assess the effectiveness of GLY on health-related quality of life and its safety in patients with COPD in a routine clinical care setting. This multi-center, prospective, six-month observational study recruited patients diagnosed with COPD and treated with GLY at three medical centers in central Taiwan. The full analysis set (n = 102) had a significant improvement in the Clinical COPD Questionnaire total (mean ± SD = −0.39 ± 0.90, p = 0.002), symptoms (mean ± SD = −0.61 ± 0.90, p < 0.001) and mental state scores (mean ± SD = −0.54 ± 1.72, p = 0.021) but not the functional state score (mean ± SD = −0.10 ± 1.15, p = 0.529). During the observational period, 58 patients (52.73%) experienced adverse events; only one adverse event (dizziness) was suspected to be related to the study drug. Three patients (2.73%) discontinued the study and GLY treatment because of an adverse event. One patient (0.91%) died during the study period because of a cerebral infarction, which was judged to be not associated with GLY treatment. In conclusion, GLY could be effective in improving the health status and is safe for patients with COPD in a real-life setting. [ABSTRACT FROM AUTHOR]

Arschang Valipour,1 Sergey Avdeev,2 Adam Barczyk,3 Valentina Bayer,4 Zvi Fridlender,5 Mariela Georgieva,6 Ondřej Kudela,7 Alexey Medvedchikov,8 Ramona Miron,9 Maria Sanzharovskaya,8 Virginija Šileikienė,10 Jurij Šorli,11 Marc Spielmanns,12 Zsuzsanna Szalai13 1Department of Respiratory and Critical Care Medicine, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Vienna Health Care Group, Klinik Floridsdorf, Vienna, Austria; 2I.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia; 3Wydział Nauk Medycznych Śląskiego Uniwersytetu Medycznego, Katowice, Poland; 4Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 5Hadassah-Hebrew University Medical Center, Jerusalem, Israel; 6Medical Center “Sv.ivan Rilski” OOD, Vidin, Bulgaria; 7Department of Pneumology, Faculty of Medicine in Hradec Kralove, University Hospital Hradec Kralove, Charles University in Prague, Hradec Kralove, Czech Republic; 8Boehringer Ingelheim RCV GmbH & Co. KG, Vienna, Austria; 9Clinical Pneumophtysiology Hospital Iasi, Iasi, Romania; 10Faculty of Medicine, Clinic of Chest Diseases, Immunology and Allergology, Institute of Clinical Medicine, Vilnius University, Vilnius, Lithuania; 11Bolnišnica Topolšica, Topolšica, Slovenia; 12Zürcher RehaZentrum Wald, Wald, Switzerland; 13Petz Aladar County Teaching Hospital, Gyor, HungaryCorrespondence: Arschang ValipourDepartment of Respiratory and Critical Care Medicine, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Vienna Health Care Group, Klinik Floridsdorf, Brünner Straße 68, 1210 Vienna, AustriaTel +43 1 277 00-72201Fax +43 1 277 00 99 2208Email arschang.valipour@gesundheitsverbund.atBackground: The Clinical COPD Questionnaire (CCQ) is a simple patient-reported tool to measure clinical control of chronic obstructive pulmonary disease (COPD).Objective: This open-label, single-arm, non-interventional study (NCT03663569) investigated changes in CCQ score during treatment with tiotropium/olodaterol in clinical practice.Methods: Data were included from consenting COPD patients, enrolled in Bulgaria, Czech Republic, Hungary, Israel, Lithuania, Poland, Romania, Russia, Slovenia, Switzerland and Ukraine, who were receiving a new prescription for tiotropium/olodaterol according to the treating physician in a real-world environment. The primary endpoint was the occurrence of therapeutic success, defined as a 0.4-point decrease in CCQ score after treatment with tiotropium/olodaterol for approximately 6 weeks.Results: Overall, 4819 patients were treated; baseline and Week 6 CCQ scores were available for 4700 patients, mostly classified as Global Initiative for Chronic Obstructive Lung Disease (GOLD) B (51.6%) or D (42.7%). After 6 weeks’ treatment, 81.4% (95% confidence interval [95% CI] 80.24– 82.49) of patients achieved therapeutic success; mean improvement in overall CCQ score was 1.02 points (95% CI 1.00– 1.05). Improved CCQ score was seen in 92.2% of patients (95% CI 91.43– 92.98), 2.5% had no change and 5.3% showed a worsening. When stratified by prior treatment, the greatest benefit was seen in treatment-naïve patients, with 85.7% achieving therapeutic success, compared with 79.5% of those pretreated with long-acting β2-agonist (LABA)/inhaled corticosteroid (ICS) and 74.2% of those pretreated with LABA or long-acting muscarinic antagonist (LAMA) monotherapy. Overall, rescue medication decreased by 1.25 puffs/day (95% CI 1.19– 1.31) versus baseline. In total, 29 patients (0.6%) reported drug-related adverse events and 7 patients reported serious adverse events (0.15%).Conclusion: In 4700 COPD patients, 6 weeks’ treatment with tiotropium/olodaterol, as initial treatment or follow-up to LAMA or LABA monotherapy or LABA/ICS, improved CCQ and decreased rescue medication use. The adverse event profile was consistent with the known safety profile of tiotropium/olodaterol.Keywords: tiotropium, olodaterol, COPD, CCQ, Clinical COPD Questionnaire, non-interventional study

Introduction: Chronic Obstructive Pulmonary Disease (COPD), a globally prevalent disease holds a huge stake among all pulmonary patients being admitted throughout the year. Various disease specific and health related quality of life questionnaires such as the Constructed Response Question (CRQ) and St. George’s Respiratory Questionnaire (SGRQ) are readily available, although, attributing to their complex structure, they can’t be used in a widespread manner. Some new scores like COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ) were developed to ease-off this dilemma. However, there is a need to justify usage of these patient-friendly simplified scores by objectifying their inter-score reliability and correlation with disease severity and progression using statistical analysis. Aim: To analyse efficacious use of CAT, CCQ score and modified Medical Research Council (mMRC) scale in assessing health status of COPD with exacerbation. Additionally, it was also targeted to assess the inter-score correlation and reliability. Materials and Methods: A total of 180 confirmed cases of COPD with exacerbation were included in this study and subjected to requisite biochemical parameters, assessment scores at their admission, after 1 week and then after 4-6 week (at stabilisation) and spirometry. 136 patients were followed-up to 4-6 weeks and studied. Quantitative and qualitative variables thus obtained were compared statistically to find out correlation, if any. A p-value of

Introduction: Chronic Obstructive Pulmonary Disease (COPD), a globally prevalent disease holds a huge stake among all pulmonary patients being admitted throughout the year. Various disease specific and health related quality of life questionnaires such as the Constructed Response Question (CRQ) and St. George’s Respiratory Questionnaire (SGRQ) are readily available, although, attributing to their complex structure, they can’t be used in a widespread manner. Some new scores like COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ) were developed to ease-off this dilemma. However, there is a need to justify usage of these patient-friendly simplified scores by objectifying their inter-score reliability and correlation with disease severity and progression using statistical analysis. Aim: To analyse efficacious use of CAT, CCQ score and modified Medical Research Council (mMRC) scale in assessing health status of COPD with exacerbation. Additionally, it was also targeted to assess the inter-score correlation and reliability. Materials and Methods: A total of 180 confirmed cases of COPD with exacerbation were included in this study and subjected to requisite biochemical parameters, assessment scores at their admission, after 1 week and then after 4-6 week (at stabilisation) and spirometry. 136 patients were followed-up to 4-6 weeks and studied. Quantitative and qualitative variables thus obtained were compared statistically to find out correlation, if any. A p-value of <0.05 was considered significant. Results: Mean difference between CAT score at exacerbation and at 1 week and CAT score at exacerbation and at 4-6 weeks were statistically significant. The changes in CCQ scores from exacerbation to 1 week and 6 weeks were also found to be statistically significant. Similar pattern was also observed in assessing timescale variability of mMRC score. There was good correlation between CAT, CCQ and mMRC scores at exacerbation, 1 week and it continually intensified as patients progressed towards a more stable state (4-6 weeks). Similar pattern was also observed with significant progressive positive correlation between change in CAT, CCQ and mMRC scores from exacerbation to 1 week and from exacerbation to 4-6 weeks. Conclusion: These score have a high correlative reliability when used to assess health status among various stages of disease from exacerbation towards a stable state. Similarly, correlation between change of individual score from exacerbation towards recovery state was also high. [ABSTRACT FROM AUTHOR]

Background: The Clinical COPD Questionnaire (CCQ) has been suggested by the Global Initiative of Chronic Obstructive Lung Disease (GOLD) as a comprehensive symptom measurement tool, which helps to classify patients in order to direct pharmacological treatment. Therefore, it is essential to understand its determinants. Objectives: To identify the determinants of the overall CCQ score and scores of its 3 subdomains among chronic obstructive pulmonary disease (COPD) patients from China. Methods: A total of 1,241 COPD patients in the outpatient department of the Second Xiangya Hospital in China were recruited. Basic information and clinical data were collected. Differences in the GOLD categories based on Modified Medical Research Council Dyspnea Scale (mMRC), COPD Assessment Test (CAT), and CCQ were compared. Multiple linear regression analyses were performed to evaluate determinant factors of the total CCQ and subdomain scores. Results: The total CCQ and/or separate domain scores significantly differed with sex, age, BMI, smoking status, biomass fuel exposure, exacerbation frequency, mMRC, CAT, and GOLD grades and groups. Subjects with asthma-COPD overlap (ACO) had worse health status based on CCQ than those with COPD alone. As for the 16 subgroups based on GOLD 2017, statistical differences in the total CCQ and functional domain scores were found among subgroups 1A–4A, 1B–4B, and 1D–4D. The mMRC classified much more patients into more symptom groups than CAT and CCQ. No significant difference was observed in the GOLD categories between the CAT and CCQ (cut point = 1.5). Multiple linear regression analysis showed that smoking status, underweight, ACO, post-bronchodilator FEV1% predicted <50%, exacerbation history, and mMRC were independently associated with the total CCQ score. Only 3 variables were significantly associated with the symptom domain: ACO, exacerbations, and mMRC; for the functional domain, age ≥75 years, ACO, post-bronchodilator FEV1% predicted <50%, exacerbation history, and mMRC were significant; female sex, underweight, frequent exacerbations (≥2), and mMRC were significantly associated with higher scores in the mental domain. Conclusions: The classification of COPD produced by mMRC, CAT, and CCQ was not identical. Smoking status, underweight, ACO, post-bronchodilator FEV1% predicted <50%, exacerbation history, and mMRC were associated with lower health-related quality of life assessed by the total CCQ score, while different subdomains of CCQ had different determinant factors. [ABSTRACT FROM AUTHOR]

Objectives: Spirometric evaluation of upper airway obstruction (UAO) is not commonly performed by Otolaryngologists. In addition, functional evaluation of UAO by flow‐volume loops (FVL) is not available in all clinical settings. More recently, peak inspiratory flow (PIF) has proven to be a useful tool to monitor UAO at the patient's bedside. The aim of this work is to assess the role of PIF measured with a simple flow metre (In‐Check method) as a standardised, simple, non‐invasive tool in quantifying chronic and subacute UAO in a routine clinical practice. In addition, a Clinical COPD Questionnaire (CCQ), previously validated to assess the psychophysical status in patients with laryngotracheal stenosis, was utilised to evaluate respiratory function in UAO. Design: Prospective cohort study. Settings: University teaching hospital. Participants: Seventy 2 subjects, an UAO group of 26 patients and a control group of 46 healthy subjects. Main outcome measures: The ability of PIF values to discriminate between the UAO group and the control group was assessed using a ROC curve. A Spearman rank correlation was used to test the relationship between PIF measurements and the global CCQ score. Additionally, an analysis of CCQ at domain and items levels was performed. Results: Peak inspiratory flow values were accurate, with an area under the ROC curve (AUC) of 0.98 (P < .05) for differentiating the control group from the UAO group. A threshold PIF value of 170 L/min was found for diagnosing UAO. An inconclusive negative trend was found (r = −.19; P = .35) between PIF values and CCQ global score. Concerning CCQ, the symptoms domain was the most affected by UAO, higher than mental domains (P < .001) as well as functional domains (P < .01). Exertional dyspnoea and cough were the items that obtained the highest disturbed scores. Conclusions: Peak inspiratory flow is a non‐invasive, quantitative parameter to evaluate the severity of UAO. Testing can be easily performed in a routine clinical setting, with a non‐expensive hand‐held device, and could help medical follow‐up programmes and prevent emergency situations. However, FVL may be necessary for further assessment of UAO diseases. The CCQ confirms that exertional dyspnoea is the main symptom of UAO, but cough remains a common symptom. [ABSTRACT FROM AUTHOR]

Introduction: Anxiety and depression are important but often under-diagnosed co-morbid conditions in patients with Chronic Obstructive Pulmonary Disease (COPD) which may affect the functional capacity of the patients. Aim: To find out the proportion of depression and anxiety among stable COPD patients using a validated questionnaire suitable for use in clinic and the factors affecting their reduced functional capability as assessed by six-minute walk test. Materials and Methods: This was a descriptive cross-sectional study. Seventy five patients diagnosed with stable COPD in outpatient Department of Pulmonary Medicine in a tertiary care hospital, satisfying all inclusion criteria, were included in the study. They were examined clinically, categorized as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity assessment guideline and interviewed by designated interviewer using validated questionnaire for depression (Hamilton depression rating scale, HAM-D) and anxiety (State Trait Anxiety Inventory, STAI). The functional exercise capacity of the patient was assessed by six-minute walk test. Statistical analysis was performed using Minitab software (version16.1). Results: Among 75 stable COPD patients (68 male, 7 female), majority (32 out of 75) had both depression and anxiety, while only anxiety or depression was present in 9 each. The patients with depression had no significant difference in six-minute walk distance, change in heart rate and respiratory rate (p = 0.4186, 0.219 and 0.41 respectively) as compared to those without depression, but were found to be more dyspnoeic at the end of the test (p= 0.003). There was also no significant difference in walk distance in patients with high STAI score as compared to those with low STAI score (p= 0.276). Conclusion: Both anxiety and depression were present in majority of the stable COPD patients. The presence of these co-morbid conditions had no significant effect on the functional status of the patients in the form of reduced six-minute walk distance, though they were more symptomatic than those without these co-morbidities.

The clinical COPD questionnaire (CCQ) has been developed to measure the health status of COPD patients. The aim of this study was to translate CCQ into the Persian language and assess the validity and reliability of the translated version. We used a forward-backward procedure to translate the questionnaire. In a cross-sectional study 100 COPD patients and 50 healthy subjects over 40 years old were selected to assess the reliability and construct validity of the instrument. The face and content validity were used for the questionnaire validity. Validity was examined in a population of patients with COPD, using the Persian validated version of the St George's Respiratory Questionnaire (PSGRQ). In order to assess the questionnaire’s reliability, the Intraclass correlation coefficient (ICC) and Cronbach’s alpha were calculated. Test-retest reliability was tested by re-administering the Persian version of the CCQ (PCCQ) after 1 week. Test-retest carry out of data demonstrates that the PCCQ has excellent reliability (ICC for all 3 domains were higher than 0.9). Internal consistency was found by Cronbach’s alpha to be 0.96, 0.94, 0.97, and 0.98 for the symptom, mental state, functional state and total scores respectively. In addition, the correlation between the components of PCCQ and PSGRQ showed satisfactory construct validity. Analyzing the data from healthy subjects and patients divulged that the PCCQ has acceptable discriminant validity. In general, the PCCQ had satisfactory reliability and validity for assessing health-related quality of life status of Iranian COPD patients.

Introduction: Anxiety and depression are important but often under-diagnosed co-morbid conditions in patients with Chronic Obstructive Pulmonary Disease (COPD) which may affect the functional capacity of the patients. Aim: To find out the proportion of depression and anxiety among stable COPD patients using a validated questionnaire suitable for use in clinic and the factors affecting their reduced functional capability as assessed by six-minute walk test. Materials and Methods: This was a descriptive cross-sectional study. Seventy five patients diagnosed with stable COPD in outpatient Department of Pulmonary Medicine in a tertiary care hospital, satisfying all inclusion criteria, were included in the study. They were examined clinically, categorized as per Global Initiative for Chronic Obstructive Lung Disease (GOLD) severity assessment guideline and interviewed by designated interviewer using validated questionnaire for depression (Hamilton depression rating scale, HAM-D) and anxiety (State Trait Anxiety Inventory, STAI). The functional exercise capacity of the patient was assessed by six-minute walk test. Statistical analysis was performed using Minitab software (version16.1). Results: Among 75 stable COPD patients (68 male, 7 female), majority (32 out of 75) had both depression and anxiety, while only anxiety or depression was present in 9 each. The patients with depression had no significant difference in six-minute walk distance, change in heart rate and respiratory rate (p = 0.4186, 0.219 and 0.41 respectively) as compared to those without depression, but were found to be more dyspnoeic at the end of the test (p= 0.003). There was also no significant difference in walk distance in patients with high STAI score as compared to those with low STAI score (p= 0.276). Conclusion: Both anxiety and depression were present in majority of the stable COPD patients. The presence of these co-morbid conditions had no significant effect on the functional status of the patients in the form of reduced six-minute walk distance, though they were more symptomatic than those without these co-morbidities. [ABSTRACT FROM AUTHOR]

Purpose Chronic obstructive pulmonary disease (COPD) is a progressive disease that impairs both objectively measured lung function and patient-reported health status. In a randomized clinical trial of patients with moderate to severe COPD, we compared changes in health status after adding arformoterol tartrate or placebo to patients’ treatment regimens. Methods In this multicenter, double-blind trial, patients were randomized to receive nebulized arformoterol 15 µg BID (n = 420) or matched placebo (n = 421). Treatment with other COPD medications was permitted, except for long-acting β 2 -agonists. Inclusion criteria were a forced expiratory volume in 1 second (FEV 1 ) ≤65% of predicted, FEV 1 >0.50 L, age ≥40 years, smoking history ≥15 pack-years, and a baseline breathlessness severity grade ≥2. The Clinical COPD Questionnaire (CCQ) was used to measure health status at randomization and at months 3, 6, and 12. CCQ scores range from 0 to 6, with higher scores indicating worse health status, and a decrease from baseline in total score by 0.4 point is considered clinically significant. Outcomes were analyzed by using mixed models for repeated measures. Findings At baseline, patients’ mean age was 63.8 years; 42.9% of patients were female, and 51.4% were current smokers. The mean baseline CCQ total scores were 2.88 and 2.91 for the arformoterol and placebo groups, respectively. A total of 841 patients were randomized to receive either arformoterol (n = 420) or placebo (n = 421); among them, 211 (50.1%) who received placebo and 255 (60.7%) who received arformoterol completed the trial. Arformoterol-treated patients had greater mean improvement from baseline in CCQ total score (−0.18 vs 0.02; P = 0.001), symptoms (−0.21 vs 0.01; P = 0.002), functional state (−0.15 vs 0.02; P = 0.018), and mental state (−0.18 vs 0.02; P = 0.023) than patients receiving placebo. At study end, 38.3% of the arformoterol-treated patients and 30.8% of patients receiving placebo reported clinically significant improvements on the CCQ ( P = 0.026). These improvements were only modestly correlated with improvements in FEV 1 ( r = −0.15; P < 0.01). Implications In this 52-week trial, arformoterol-treated patients had greater improvements in health status than patients receiving placebo. Assessing health status along with lung function seems to provide additional information regarding the effectiveness of COPD maintenance treatments. ClinicalTrials.gov identifier: NCT00909779. [ABSTRACT FROM AUTHOR]

Background: Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity in the elderly population. COPD leads to a reduced health-related quality of life (HRQL), but the factors which contribute to this are not well understood. A better understanding of the factors which determine HRQL should lead to an improved care for such patients. Objectives: The purpose of this study was to investigate possible age-related differences in HRQL in a population of patients with a similar severity of obstruction. Methods: A total of 180 consecutive COPD patients were enrolled into the study. We analyzed spirometric data, BODE index and its components, and comorbidities were assessed by the Charlson index. HRQL was assessed by the Clinical COPD Questionnaire (CCQ) and St. George's Respiratory Questionnaire (SGRQ). Results: The cohort consisted of 93 'younger' patients (mean age 54.8 ± 3.1 years) and 87 older patients (mean age 73.1 ± 5.5 years). Patients in both groups had a similar severity of obstruction: FEV1 (%from predicted) was 39.9 ± 13.2% in the elderly group compared to 41.7 ± 11.7% in the younger group (p > 0.05). The forward stepwise regression analysis shows that the BODE index, the Charlson index, and the rate of exacerbations are important predictors of deterioration of HRQL in elderly COPD patients, which explains 29% of the total SGRQ score. In the younger COPD patients, the coefficient of determination R² was 0.27, but the predictors were the BODE index and the rate of exacerbations. Conclusions: The BODE index, the Charlson index, and the rate of exacerbations were found to be the major determinants of HRQL in elderly COPD patients, while in younger COPD patients, the BODE index and the rate of exacerbations were influential factors. [ABSTRACT FROM AUTHOR]

The clinical COPD questionnaire (CCQ) has been developed to measure the health status of COPD patients. The aim of this study was to translate CCQ into the Persian language and assess the validity and reliability of the translated version. We used a forward-backward procedure to translate the questionnaire. In a cross-sectional study 100 COPD patients and 50 healthy subjects over 40 years old were selected to assess the reliability and construct validity of the instrument. The face and content validity were used for the questionnaire validity. Validity was examined in a population of patients with COPD, using the Persian validated version of the St George's Respiratory Questionnaire (PSGRQ). In order to assess the questionnaire's reliability, the Intraclass correlation coefficient (ICC) and Cronbach's alpha were calculated. Test-retest reliability was tested by re-administering the Persian version of the CCQ (PCCQ) after 1 week. Test-retest carry out of data demonstrates that the PCCQ has excellent reliability (ICC for all 3 domains were higher than 0.9). Internal consistency was found by Cronbach's alpha to be 0.96, 0.94, 0.97, and 0.98 for the symptom, mental state, functional state and total scores respectively. In addition, the correlation between the components of PCCQ and PSGRQ showed satisfactory construct validity. Analyzing the data from healthy subjects and patients divulged that the PCCQ has acceptable discriminant validity. In general, the PCCQ had satisfactory reliability and validity for assessing health-related quality of life status of Iranian COPD patients. [ABSTRACT FROM AUTHOR]

Background: Replicate, 12-week, phase 3 trials (0126 and 0127) of once-daily nebulized revefenacin 175 μg vs placebo demonstrated significant bronchodilation and improvements in health status in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). This post hoc analysis evaluated improvement in patient-reported outcomes (PROs), including the St. George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Clinical COPD Questionnaire (CCQ) in both women and men., Methods: Participants were pooled from the two 12-week studies (411 [51%] women and 401 [49%] men). Changes in PROs were assessed overall and separately in men and women., Results: Revefenacin improved SGRQ and CAT total scores from baseline in both studies; improvement in CCQ total score reached significance only in 0126. In pooled data, a greater proportion of patients achieved clinically meaningful response in SGRQ score (≥4-unit decrease from baseline) with revefenacin vs placebo (odds ratio, 1.5; 95% confidence interval, 1.1-2.1; P = 0.012). Clinically meaningful responses were also seen in CAT (≥2-unit decrease from baseline) and CCQ (≥0.4-unit decrease from baseline) scores with revefenacin vs placebo. When stratified by sex, improvements from baseline in SGRQ, CAT, and CCQ scores following revefenacin vs placebo reached statistical significance only in women., Conclusions: Maintenance treatment with revefenacin improved health status in patients with moderate to very severe COPD; however, the effect was more pronounced for women than men., Clinicaltrials: GOV: NCT02459080; NCT02512510., Competing Interests: Declaration of competing interest JFD is a consultant and advisory committee member for Theravance Biopharma US, Inc.; Sunovion Pharmaceuticals; and Mylan, a Viatris company. GTF is a consultant and speaker for and received financial support from Theravance Biopharma US, Inc., and Mylan, a Viatris company. JAO served on advisory boards for AstraZeneca, Boehringer Ingelheim, GSK, Mylan Inc., Reckitt Benckiser, Sunovion Pharmaceuticals, and Theravance Biopharma US, Inc.DAL was a contract employee of Theravance Biopharma US, Inc., at the time of this study. RFS is an employee of BioMarin Pharmaceuticals, Inc.; received consulting fees from GSK, Merck, and BreathResearch; and received salary from Pfizer and from Theravance Biopharma US, Inc., where she was employed when these analyses were done. KJ is an employee of Theravance Biopharma US, Inc., (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Background and Aim: The purpose of the present study was to determine the influence of demographic variables and disease characteristics on the quality of life scores and the distribution of the scores at different stages of Chronic Obstructive Pulmonary Disease (COPD). Materials and Methods: One hundred patients with COPD participated in this cross-sectional study. Interview and the validated Persian version of the clinical COPD questionnaire (PCCQ) were used for data collection. The method of data collection for the study was interview with a demographic and validated Persian version of the clinical COPD questionnaire (PCCQ). Results: Six percent of patients were revealed as mild COPD, 34 percent of patients as moderate COPD, 49 percent of patients as severe COPD and 11 percent of patients as very severe COPD. Significant differences were observed for total score and the component scores of the PCCQ among four stages of the disease. The age and length of the disease correlated significantly with the total PCCQ score (P<0.05). In order to compare between the CCQ total score and three domains of male and female groups, the results showed that women compared to men had lower quality of life in CCQ total score and functional areas (P<0/5). Conclusion: Distribution of the quality of life scores in patients with different stages of COPD patients showed that there is an overlap quality of life scores in the mild, moderate, severe and very severe stages of COPD patients. As a result, classifying the disease using spirometry cannot distinct patients with COPD according to impairments in their health status. In adittion, the age, sex and length of the disease are the main factors that may affect the quality of life. [ABSTRACT FROM AUTHOR]

Hospitalisations for chronic obstructive pulmonary disease (COPD) exacerbations are characterised by a significant worsening of the respiratory symptoms which can impair the health status (HS). However little is known on the HS behaviour during such events. Prospective study evaluating the validity of the Clinical COPD Questionnaire (CCQ) as a HS measure in hospitalisations for COPD exacerbations. The CCQ total score (CCQ-T) correlated with EQ-VAS (-0.51, p < 0.0001), was able to discriminate between longer and shorter duration hospitalisation (CCQ-T 3.83 vs 3.03, respectively p = 0.001), had a Cronbach-α of 0.86, and improved significantly over the hospitalisation period (CCQ-T on day 7 of hospitalisation 2.55 vs 3.77 at baseline, p < 0.0001). CCQ is an excellent tool for the assessment of the HS dynamics in hospitalisations for COPD exacerbations. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to examine the changing influence over time of comorbid heart disease on symptoms and health status in patients with COPD., Patients and Methods: This is a prospective cohort study of 495 COPD patients with a baseline in 2005 and follow-up in 2012. The study population was divided into three groups: patients without heart disease (no-HD), those diagnosed with heart disease during the study period (new-HD) and those with heart disease at baseline (HD). Symptoms were measured using the mMRC. Health status was measured using the Clinical COPD Questionnaire (CCQ) and the COPD Assessment Test (CAT; only available in 2012). Logistic regression with mMRC ≥2 and linear regression with CCQ and CAT scores in 2012 as dependent variables were performed unadjusted, adjusted for potential confounders, and additionally adjusted for baseline mMRC, respectively, CCQ scores., Results: Mean mMRC worsened from 2005 to 2012 as follows: for the no-HD group from 1.8 (±1.3) to 2.0 (±1.4), ( P =0.003), for new-HD from 2.2 (±1.3) to 2.4 (±1.4), ( P =0.16), and for HD from 2.2 (±1.3) to 2.5 (±1.4), ( P =0.03). In logistic regression adjusted for potential confounding factors, HD (OR 1.71; 95% CI: 1.03-2.86) was associated with mMRC ≥2. Health status worsened from mean CCQ as follows: for no-HD from 1.9 (±1.2) to 2.1 (±1.3) with ( P =0.01), for new-HD from 2.3 (±1.5) to 2.6 (±1.6) with ( P =0.07), and for HD from 2.4 (±1.1) to 2.5 (±1.2) with ( P =0.57). In linear regression adjusted for potential confounders, HD (regression coefficient 0.12; 95% CI: 0.04-5.91) and new-HD (0.15; 0.89-5.92) were associated with higher CAT scores. In CCQ functional state domain, new-HD (0.14; 0.18-1.16) and HD (0.12; 0.04-0.92) were associated with higher scores. After additional correction for baseline mMRC and CCQ, no statistically significant associations were found., Conclusion: Heart disease contributes to lower health status and higher symptom burden in COPD but does not accelerate the worsening over time., Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Purpose: DINO and DACOTA were prospective, noninterventional studies assessing the health status and quality of life of patients with COPD newly treated with roflumilast 500 μg once-daily add-on therapy., Patients and Methods: Patients were evaluated over 6 months. Clinical COPD questionnaire (CCQ) and COPD assessment test (CAT) scores were recorded at baseline and after 3 and 6 months. In DACOTA, post-bronchodilator FEV 1 was recorded at each time point., Results: Of 5,462 and 3,645 patients recruited into DINO and DACOTA, respectively, 3,274 patients in DINO and 916 patients in DACOTA completed the 6-month visit. Almost all patients had severe or very severe airway obstruction; mean baseline CCQ total score was 3.9 in DINO and 3.7 in DACOTA. Overall, 33.8% of patients in DACOTA and 30.6% in DINO discontinued treatment prematurely. Significant and clinically relevant improvements in CCQ total scores were observed in both studies (mean change from baseline of 1.36 in DINO and 0.91 in DACOTA at Month 6 [all P <0.001]). Changes in CAT total score from baseline to Month 6 indicated that the average clinical impact of COPD was reduced from a severe (score: 21-30) to a moderate (score: 11-20) impairment. In DACOTA, mean change in post-bronchodilator FEV 1 was 202 mL ( P <0.001). Diarrhea, nausea, and weight decrease were the most frequently reported adverse drug reactions., Conclusion: In real-life clinical practice, roflumilast treatment as an add-on therapy is associated with clinically relevant improvements in health status and quality of life., Competing Interests: Disclosure IM is a former employee of Takeda and a current employee of AstraZeneca. PK reports personal fees from Takeda during the conduct of the study; personal fees from AstraZeneca, Chiesi, GSK, Novartis, Menarini, Teva, and Mundipharma outside the submitted work. CV reports no relevant conflicts of interest in the current study, and the following relevant financial activities outside of the submitted work: personal fees from Almirall, Cipla, Berlin Chemie/Menarini, CSL Behring, and Teva; grants and personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Grifols, Mundipharma, Novartis, and Takeda; grants from German Federal Ministry of Education and Research (BMBF) Competence Network Asthma and COPD (ASCONET), Bayer Schering Pharma AG, MSD, and Pfizer. RS reports no conflicts of interest in this work. The authors report no other conflicts of interest in this work.

Background : The 2014 updated Global initiative for chronic Obstructive Lung Disease (GOLD) strategy added the St. George's Respiratory Questionnaire (SGRQ) as the fourth possible symptoms measure. The impact of the suggested tools for symptoms of COPD and the different definitions of future risk on the frequency distribution and clinical characteristics of the GOLD groups remain unknown. Methods : Demographic and clinical characteristics were assessed in 542 patients with COPD (57.7% male, age 64.6 [9.0] years, FEV 1 54.7 [22.3]% predicted). Health status was assessed by the COPD-specific SGRQ and symptoms of anxiety and depression by the Hospital Anxiety and Depression Scale, anxiety (HADS-A) and depression (HADS-D) subscale. Cohen's Kappa was used to assess agreement between groups. Results : Level of agreement in frequency distribution using the modified Medical Research Council dyspnea (mMRC) scale ≥2, COPD Assessment Test (CAT) ≥10, Clinical COPD Questionnaire (CCQ) ≥1 and SGRQ ≥25 was moderate to very good. Best agreement was reached between CCQ and SGRQ (К = 0.838 or 0.851, p<0.001). Patients classified in mMRC GOLD A reported higher SGRQ scores, higher HADS-A and HADS-D scores compared to patients classified in CAT GOLD A or SGRQ GOLD A. Outcomes were comparable between the risk assessment groups. Conclusions : Choice of the symptom measure impacts GOLD groups more than choice of the exacerbation risk assessment. Health care professionals should be aware that patients are heterogeneous in terms of health status and symptoms of anxiety and depression based on the symptom measure used., Competing Interests: SW, DES, MAS, DJAJ, JWMM, MvdA and FMEF have nothing to disclose. TvdM developed the CCQ and holds the copyrights. PWJ did not receive any payment or services from a third party for any aspect of the submitted work, but reports grants and personal fees from GSK, personal fees from Novartis, Almirall, Pearl and Jannsen and his university received consulting fees for work that he performed for Novartis (outside the submitted work). EFMW did not receive any payment or services from a third party for any aspect of the submitted work, but reports grants and/or personal fees from Nycomed, AstraZeneca, GSK and Novartis (outside the submitted work).

Background: Chronic obstructive pulmonary disease (COPD) and heart failure (HF) are both common diseases that coexist frequently. Patients with both diseases have worse stable state health status when compared with patients with one of these diseases. In many outpatient clinics, health status is monitored routinely in COPD patients using the Clinical COPD Questionnaire (CCQ) and in HF patients with the Minnesota Living with Heart Failure Questionnaire (MLHF-Q). This study validated and compared which questionnaire, ie, the CCQ or the MLHF-Q, is suited best for patients with coexistent COPD and HF., Methods: Patients with both COPD and HF and aged ≥40 years were included. Construct validity, internal consistency, test-retest reliability, and agreement were determined. The Short-Form 36 was used as the external criterion. All questionnaires were completed at baseline. The CCQ and MLHF-Q were repeated after 2 weeks, together with a global rating of change., Results: Fifty-eight patients were included, of whom 50 completed the study. Construct validity was acceptable. Internal consistency was adequate for CCQ and MLHF-Q total and domain scores, with a Cronbach's alpha ≥0.70. Reliability was adequate for MLHF-Q and CCQ total and domain scores, and intraclass correlation coefficients were 0.70-0.90, except for the CCQ symptom score (intraclass correlation coefficient 0.42). The standard error of measurement on the group level was smaller than the minimal clinical important difference for both questionnaires. However, the standard error of measurement on the individual level was larger than the minimal clinical important difference. Agreement was acceptable on the group level and limited on the individual level., Conclusion: CCQ and MLHF-Q were both valid and reliable questionnaires for assessment of health status in patients with coexistent COPD and HF on the group level, and hence for research. However, in clinical practice, on the individual level, the characteristics of both questionnaires were not as good. There is room for a questionnaire with good evaluative properties on the individual level, preferably tested in a setting of patients with COPD or HF, or both.

Background: Daily physical activity (DPA) level is reduced in patients with COPD. The aim of this study was to investigate the association of DPA with functional and psychological variables in these patients., Methods: 155 COPD patients (102 males, median (IQR) age 62 years (54-69 years), predicted FEV1 60% (40-75%) were included. We assessed DPA (DigiWalker SW-200), functional capacity and psychological factors., Results: DPA level was significantly associated with all functional capacity variables and two psychological variables (Perceived Physical Ability Subscale, depression subscale of the Hospital Anxiety and Depression Scale). The six-minute walking distance and St. George Respiratory Questionnaire activity score explained 37% of the variance of DPA in a regression analysis. A structural equations model revealed that psychological variables indirectly explained DPA through functional capacity variables. DPA was stronger associated with functional capacity variables and weaker with psychological variables in patients with lower functional status than in patients with higher functional status., Conclusions: Higher levels of DPA are associated with better functional capacity, but interestingly, DPA is also affected by psychological factors, though only indirectly, via functional capacity. The effect of specific treatment addressing psychological factors on DPA level and exercise tolerance needs further investigation., Clinical Trial Registration: ClinicalTrials.gov, NCT00614796., (Copyright © 2013 Elsevier Ltd. All rights reserved.)

Background: Exacerbations of chronic obstructive pulmonary disease (COPD) are a major burden to patients and to society. Little is known about the possible role of day-to-day patient-reported outcomes during an exacerbation. This study aims to describe the day-to-day course of patient-reported health status during exacerbations of COPD and to assess its value in predicting clinical outcomes., Methods: Data from two randomized controlled COPD exacerbation trials (n = 210 and n = 45 patients) were used to describe both the feasibility of daily collection of and the day-to-day course of patient-reported outcomes during outpatient treatment or admission to hospital. In addition to clinical parameters, the BORG dyspnea score, the Clinical COPD Questionnaire (CCQ), and the St George's Respiratory Questionnaire were used in Cox regression models to predict treatment failure, time to next exacerbation, and mortality in the hospital study., Results: All patient-reported outcomes showed a distinct pattern of improvement. In the multivariate models, absence of improvement in CCQ symptom score and impaired lung function were independent predictors of treatment failure. Health status and gender predicted time to next exacerbation. Five-year mortality was predicted by age, forced expiratory flow in one second % predicted, smoking status, and CCQ score. In outpatient management of exacerbations, health status was found to be less impaired than in hospitalized patients, while the rate and pattern of recovery was remarkably similar., Conclusion: Daily health status measurements were found to predict treatment failure, which could help decision-making for patients hospitalized due to an exacerbation of COPD.