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Effects of aclidinium on determinants of COPD severity: symptoms and quality of life.

ABSTRACT: The pathophysiology of chronic obstructive pulmonary disease (COPD) includes persistent airflow limitation, altered gas exchange, and enhanced chronic inflammatory response. According to disease severity in individual patients, exacerbations and comorbidities frequently occur. The overall nocturnal and daily symptoms have a strong impact on patient quality of life and clinical outcomes. Bronchodilators, by targeting two important aspects of COPD pathophysiology, ie, bronchoconstriction and lung hyperinflation, are the mainstay of therapy for COPD. Aclidinium bromide in particular is an anticholinergic molecule, approved for maintenance bronchodilator treatment of stable COPD, that combines high antimuscarinic activity with strong kinetic selectivity for the M3 receptor subtype. Moreover, the elevated plasma clearance of aclidinium has been related to low systemic bioavailability and low incidence of anticholinergic adverse events, whereas the reduced residence time at M2 receptors provides good cardiovascular safety. Altogether, these characteristics result in a high safety and tolerability profile. This review aims to reappraise the contribution of symptoms and of the level of quality of life determinants on COPD severity and to evaluate how therapeutic strategies with aclidinium may positively impact on these specific determinants of disease severity.

SUBMITTER: Contoli M

PROVIDER: S-EPMC5147412 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Effects of aclidinium on determinants of COPD severity: symptoms and quality of life.

Contoli Marco M Solidoro Paolo P Di Marco Fabiano F Scichilone Nicola N Corsico Angelo A Braido Fulvio F Santus Pierachille P

International journal of chronic obstructive pulmonary disease 20161205

The pathophysiology of chronic obstructive pulmonary disease (COPD) includes persistent airflow limitation, altered gas exchange, and enhanced chronic inflammatory response. According to disease severity in individual patients, exacerbations and comorbidities frequently occur. The overall nocturnal and daily symptoms have a strong impact on patient quality of life and clinical outcomes. Bronchodilators, by targeting two important aspects of COPD pathophysiology, ie, bronchoconstriction and lung ...[more]

PMID: 27980401

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Project description:Patients with chronic obstructive pulmonary disease (COPD) often have poor health-related quality of life (HRQoL) that is disproportionate to their degree of airflow limitation. This study evaluated the association between St George's Respiratory Questionnaire for COPD (SGRQ-C) score and forced expiratory volume in one second and investigated the factors responsible for high SGRQ-C score according to severity of airflow limitation.Data from 1,264 COPD patients were obtained from the Korean COPD Subgroup Study (KOCOSS) cohort. Patients were categorized into two groups according to severity of airflow limitation: mild-to-moderate and severe-to-very severe COPD groups. We evaluated the clinical factors associated with high SGRQ-C score (?25) in each COPD patient group.Of the 1,264 COPD patients, 902 (71.4%) had mild-to-moderate airflow limitation and 362 (28.6%) had severe-to-very severe airflow limitation. Of the mild-to-moderate COPD patients, 59.2% (534/902) had high SGRQ-C score, while 80.4% (291/362) of the severe-to-very severe COPD patients had high SGRQ-C score. The association between SGRQ-C score and post-bronchodilator forced expiratory volume in one second (% predicted) was very weak in the mild-to-moderate COPD patients (r=-0.103, p=0.002) and weak in the severe-to-very severe COPD patients (r=-0.219, p<0.001). Multiple logistic regression analysis revealed that age, being an ex- or current smoker, lower level of education, cough, dyspnea, and number of comorbidities with congestive heart failure, hyperlipidemia, and depression were significantly associated with high SGRQ-C score in mild-to-moderate COPD patients. In comparison, being an ex-smoker and having respiratory symptoms including sputum and dyspnea were significant factors associated with high SGRQ-C score in severe-to-very severe COPD patients.In addition to the respiratory symptoms of dyspnea and cough, high SGRQ-C score was associated with extra-pulmonary comorbidities in mild-to-moderate COPD patients. However, only respiratory symptoms such as sputum and dyspnea were significantly associated with high SGRQ-C score in severe-to-very severe COPD patients. This indicates the need for an improved management strategy for relieving respiratory symptoms in COPD patients with poor HRQoL. In addition, attention should be paid to extra-pulmonary comorbidities, especially in mild-to-moderate COPD patients with poor HRQoL.

Project description:BACKGROUND:Reducing the severity of respiratory symptoms is a key goal in the treatment of chronic obstructive pulmonary disease (COPD). We evaluated the effect of aclidinium bromide 400 ?g twice daily (BID) on respiratory symptoms, assessed using the Evaluating Respiratory Symptoms in COPD (E-RS(™): COPD) scale (formerly EXACT-RS). METHODS:Data were pooled from the aclidinium 400 ?g BID and placebo arms of two 24-week, double-blind, randomized Phase III studies evaluating aclidinium monotherapy (ATTAIN) or combination therapy (AUGMENT COPD I) in patients with moderate to severe airflow obstruction. Patients were stratified by Global initiative for chronic Obstructive Lung Disease (GOLD) Groups A-D. Change from baseline in E-RS scores, proportion of responders (patients achieving pre-defined improvements in E-RS scores), and net benefit (patients who improved minus patients who worsened) were analyzed. RESULTS:Of 1210 patients, 1167 had data available for GOLD classification. Mean (standard deviation) age was 63.2 (8.6) years, 60.7 % were male, and mean post-bronchodilator forced expiratory volume in 1 s was 54.4 % predicted. Compared with placebo, aclidinium 400 ?g BID significantly improved RS-Total (2.38 units vs 0.79 units, p?<?0.001) and domain scores (all p?<?0.001) at Week 24, and doubled the likelihood of being an RS-Total score responder (p?<?0.05), irrespective of GOLD group. The net benefit for RS-Total (Overall: 56.9 % vs 19.4 %; A?+?C: 65.7 % vs 6.3 %; B?+?D: 56.0 % vs 20.8 %, for aclidinium 400 ?g BID and placebo respectively; all p?<?0.05) and domain scores (all p?<?0.05) was significantly greater with aclidinium compared with placebo, in both GOLD Groups A?+?C and B?+?D. CONCLUSIONS:Aclidinium 400 ?g BID significantly improved respiratory symptoms regardless of the patients' level of symptoms at baseline. Net treatment benefit was similar in patients with low or high levels of symptoms. TRIAL REGISTRATION:ATTAIN (ClinicalTrials.gov identifier: NCT01001494 ) and AUGMENT COPD I (ClinicalTrials.gov identifier: NCT01437397 ).

Project description:IntroductionDirectly recorded patient experience of symptoms and health-related quality of life (HRQoL) can complement lung function and exacerbation rate data in chronic obstructive pulmonary disease (COPD) clinical studies. The FULFIL study recorded daily symptoms and activity limitation together with additional patient-reported outcomes of dyspnea and HRQoL, as part of the prespecified analyses. FULFIL co-primary endpoint data have been previously reported.MethodsFULFIL was a phase III, 24-week, randomized, double-blind, double-dummy, multicenter study comparing once-daily single inhaler triple therapy [fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI)] 100 µg/62.5 µg/25 µg with twice-daily inhaled corticosteroid/long-acting β2-agonist therapy [budesonide/formoterol (BUD/FOR)] 400 µg/12 µg in patients with symptomatic COPD at risk of exacerbations. A subset participated for 52 weeks. Patient-reported assessments were: Evaluating Respiratory Symptoms in COPD™ (E-RS: COPD), St George's Respiratory Questionnaire (SGRQ) for COPD, COPD Assessment Test (CAT), baseline and transitional dyspnea indices (TDI) and daily and global anchor questions for activity limitation.ResultsFF/UMEC/VI showed greater reductions from baseline in 4-weekly mean E-RS: COPD total and all subscale scores compared with BUD/FOR; differences were statistically significant (P < 0.05) at each time period. FF/UMEC/VI also demonstrated greater improvements from baseline at weeks 4 and 24 in SGRQ domain scores and TDI focal score compared with BUD/FOR. At weeks 4 and 24, improvements greater than the minimal clinically important difference from baseline were observed in CAT score with FF/UMEC/VI, but not BUD/FOR; differences were statistically significant (P ≤ 0.003).ConclusionThese findings demonstrate sustained daily symptom and HRQoL benefits of FF/UMEC/VI versus BUD/FOR. The inclusion of the CAT may provide data that are readily generalizable to everyday clinical practice.Trial registrationClinicalTrials.gov number: NCT02345161.FundingGSK.

Project description:The aim of this study was to compare potential differences between the perception that COPD patients have of their disease and the perception that physicians have of how the disease affects their patients.Surveys in COPD patients and physicians caring for COPD patients were conducted in Spain, Italy, and Germany. Online questionnaires mirrored to explore the same domains, were administered to patients and physicians. Physicians were asked to respond to the questionnaire taking a recently seen patient who represents the majority of COPD patients usually managed, as a reference. Patients with COPD completed a survey containing the same questions offered to the physicians (Medical Investigation of Respiratory COPD Perception [MIRROR] survey). Comparisons between the responses of patients and general practitioners (GPs) and between patients and pulmonologists (PULs) were run separately using the chi-square, Fisher's exact, or Student's t-tests.A total of 334 COPD patients, 333 GPs, and 333 PULs participated in the surveys. The typical perception that PULs have of the COPD patient was that of an older man with more severe disease and less likely to be a smoker, than the included COPD patients. COPD was regarded as a major health problem by patients and physicians, but its impact on overall quality of life among more severe patients was less strongly perceived by physicians than by patients. Instead, physicians paid more attention to domains related to clinical features (cough, phlegm, and dyspnea), while underestimating COPD impact on leisure and social activities. The majority of patients stated not being completely frank with their doctors during visits. Both GPs and PULs seemed to recognize this issue but underestimated its extent.To improve the doctor-patient communication, a more frank reporting by the patients of their symptoms and feelings and an increased awareness of physicians about the impact on nonconventional domains that patients perceive as importantly affected by COPD should be encouraged.

Project description:BackgroundAlthough COPD is associated with significant health-related quality-of-life (HRQL) impairment, factors influencing HRQL in patients with COPD are not well understood, particularly in African Americans. We hypothesized that HRQL in COPD differs by race and sought to identify factors associated with those differences.MethodsWe analyzed 224 African American and 1,049 Caucasian subjects with COPD enrolled in the COPDGene (Genetic Epidemiology of COPD) Study whose conditions were classified as GOLD (Global Initiative for Chronic Obstructive Lung Disease) stages I to IV. HRQL and symptoms were compared using the St. George Respiratory Questionnaire (SGRQ) and the modified Medical Research Council Dyspnea (MMRC) scale. We constructed a mixed-effects linear regression model for SGRQ score.ResultsAfrican Americans were younger and reported fewer pack-years of smoking, more current smoking, and less attained education than Caucasians; MMRC scores were higher (P = .02) as were SGRQ scores (mean score difference, 8.4; P < .001). In a general linear model of SGRQ total score after adjusting for factors such as age, sex, and pack-years of smoking, SGRQ total score was similar for African Americans and Caucasians who reported no COPD exacerbations in the prior year. However, for subjects with exacerbations, SGRQ total score was increased to a greater relative extent for African Americans than for Caucasians (1.89 points for each exacerbation, P = .006). For hospitalized exacerbations, the effect on SGRQ total score also was greater for African Americans (4.19 points, P = .04). Furthermore, a larger percentage of African Americans reported having had at least one exacerbation that required hospitalization in the prior year (32% vs 16%, P < .001).ConclusionIn analyses that account for other variables that affect quality of life, HRQL is similar for African Americans and Caucasians with COPD without exacerbations but worse for African Americans who experience exacerbations, particularly hospitalized exacerbations.

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Effects of aclidinium on determinants of COPD severity: symptoms and quality of life.

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Effects of aclidinium on determinants of COPD severity: symptoms and quality of life.

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