scholarly journals Endobronchial Coil System versus Standard-of-Care Medical Management in the Treatment of Subjects with Severe Emphysema

Respiration ◽  
2021 ◽  
pp. 1-7
Author(s):  
Karin Klooster ◽  
Arschang Valipour ◽  
Charles-Hugo Marquette ◽  
Jacques Boutros ◽  
Hervé Mal ◽  
...  

<b><i>Background:</i></b> Bronchoscopic lung volume reduction using endobronchial coils is a new treatment for patients with severe emphysema. To date, the benefits have been modest and have been suggested to be much larger in patients with severe hyperinflation and nonmulti-comorbidity. <b><i>Objective:</i></b> We aimed to evaluate the efficacy and safety of endobronchial coil treatment in a randomized multicenter clinical trial using optimized patient selection. <b><i>Method:</i></b> Patients with severe emphysema on HRCT scan with severe hyperinflation (residual volume [RV] ≥200% predicted and RV/total lung capacity [TLC] &#x3e;55%) were randomized to coil treatment or control. Primary outcome measures were differences in the forced expiratory volume in 1 s (FEV<sub>1</sub>) and St George’s Respiratory Questionnaire (SGRQ) total score at 6 months. <b><i>Results:</i></b> Due to premature study termination, a total of 120 patients (age 63 ± 7 years, FEV<sub>1</sub> 29 ± 7% predicted, RV 251 ± 41% predicted, RV/TLC 67 ± 6%, and SGRQ 58 ± 13 points), instead of 210 patients, were randomized. At study termination, 91 patients (57 coil and 34 control) had 6-month results available. Analyses showed significantly greater improvements in favor of the coil group. The increase in FEV<sub>1</sub> was greater in the coil group than that in the control group by + 10.3 [+4.7 to +16.0] % and in SGRQ by −10.6 [−15.9 to −5.4] points. At study termination, there were 5 (6.8%) deaths in the coil cohort reported. <b><i>Conclusion:</i></b> Despite early study termination, coil treatment compared to control results in a significant improvement in the lung function and quality of life benefits for up to 6 months in patients with emphysema and severe hyperinflation. These improvements were of clinical importance but were associated with a higher likelihood of serious adverse events.

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
V Evdokimov ◽  
E Yushchuk ◽  
A Evdokimova ◽  
S Ivanova ◽  
I Sadulaeva

Abstract Purpose To compare clinical efficacy and safety of various treatment regimens with the inclusion of beta-blockers, RAAS antagonists (ACE inhibitors or ARBs), prolonged bronchodilators (LABA, LAMA) in heart failure patients with CAD and COPD. Methods 385 patients (292 men and 93 women), aged 66.3±4.1 years, with CHF classes II to III (NYHA) combined with moderate to severe COPD (GOLD) and with LVEF less than 45% were randomized into nine groups: enalapril + LAMA (control group), nebivolol + enalapril + LAMA, nebivolol + losartan + LAMA, nebivolol + losartan + LABA, nebivolol + losartan + LAMA/LABA, carvedilol + enalapril + LAMA, carvedilol + losartan + LAMA, carvedilol + losartan + LABA, carvedilol + losartan + LAMA/LABA. Patients of all groups received complex CHF treatment comprising diuretics, nitrates, cardiac glycosides (if necessary). Clinical examination, TTE, 6-minute walk test (6MWT), 24-hour electrocardiogram and blood pressure monitoring, respiratory function test were assessed at baseline and after 6 months of treatment. The quality of life was evaluated by MYHFQ, SGRQ and mMRC scale. Results After 6 months of therapy the improvement of clinical condition and quality of life were marked in all groups. At the end of observation period there was a significant improvement of patients clinical condition, quality of life, reduction of mean CHF FC and dyspnea severity, increase of exercise tolerance, slowing of progression of CHF and COPD, improvement of the parameters of intracardiac hemodynamics, structural and functional parameters of the left and right heart (a decrease in the size of the atria, LV volumes and internal dimension at end-diastole and end-systole, cardiac index, LVMMI, an increase of LVEF, a significant decrease in systemic vascular resistance and the pulmonary hypertension grade, significant improvement in systolic and diastolic function of the ventricles, regression of pathological remodeling of the heart, reduction of heart rate, duration and frequency of myocardial ischemia episodes (including its “silent” form). The best results were obtained in groups using a beta-blocker (nebivolol or carvedilol), a RAAS antagonist, and a combination of long-acting bronchodilators (indacaterol and tiotropium) – group 5 and 9. It is worth noting that beta-blockers, LABA and LAMA were well tolerated in all observation groups and serious adverse events were absent. Conclusions The appointment of 3-generation beta-blockers to patients with CHF on the background of CAD and COPD can significantly increase the effectiveness of treatment and does not cause a deterioration in spirometry in patients with such cardiopulmonary pathology. In our opinion, the most important point in the appointment of beta blockers to patients with moderate to severe COPD is low start dose and slow titration of the dose at the beginning of the therapy. It is advisable to include in the complex therapy of such patients a combination of LABA and LAMA as a basic bronchodilator support. Funding Acknowledgement Type of funding source: None


2019 ◽  
Vol 1 (2) ◽  
pp. 28-33
Author(s):  
Refi Sulistiasari

It is known that inflammation is the underlying cause of COPD, and this affects to quality of life of the patient. Provision of inhaled therapy combination of LABA and corticosteroids is one of therapy in pharmacology of stable PPOK patients. The aim of this study was to know the benefits of inhalation of 50 g / fluticasone propionate 500 g inhibition in stable COPD patients. The research design is clinical trial. The study was conducted for 3 months and was performed on 26 stable COPD patients divided into two groups: 15 patients for the treatment group and 15 patients for the control group. After the measurements were obtained, there was a significant difference in the quality of life as measured by St. George's Respiratory Questionnaire (SGRQ) (p = 0.001) and COPD Assessment Test (CAT) (0.001) measurements were made twice on the first and thirtieth days.


Author(s):  
Alejandro Piscoya ◽  
Luis Ng-Sueng ◽  
Angela Parra del Riego ◽  
Renato Cerna-Viacava ◽  
Vinay Pasupuleti ◽  
...  

IntroductionWe systematically reviewed benefits and harms of convalescent plasma (CP) in hospitalized COVID-19 patients.Material and methodsRandomized controlled trials (RCTs) and observational studies assessing CP effects on hospitalized, adult COVID-19 patients were searched until November 24, 2020. We assessed risk of bias (RoB) using Cochrane RoB 2.0 and ROBINS-I tools. Inverse variance random effect meta-analyses were performed. Quality of evidence was evaluated using GRADE methodology. Primary outcomes were all-cause mortality, clinical improvement, and adverse events.ResultsFive RCTs (n = 1067) and 6 cohorts (n = 881) were included. Three and 1 RCTs had some concerns and high RoB, respectively; and there was serious RoB in all cohorts. Convalescent plasma did not reduce all-cause mortality in RCTs of severe (RR = 0.60, 95% CI: 0.33–1.10) or moderate (RR = 0.60, 95% CI: 0.09–3.86) COVID-19 vs. standard of care (SOC); CP reduced all-cause mortality vs. SOC in cohorts (RR = 0.66, 95% CI: 0.49–0.91). Convalescent plasma did not reduce invasive ventilation vs. SOC in moderate disease (RR = 0.85, 95% CI: 0.47–1.55). In comparison to placebo + SOC, CP did not affect all-cause mortality (RR = 0.75, 95% CI: 0.48–1.16) or clinical improvement (HR = 1.07, 95% CI: 0.82–1.40) in severe patients. Adverse and serious adverse events were scarce, similar between CP and controls. Quality of evidence was low or very low for most outcomes.ConclusionsIn comparison to SOC or placebo + SOC, CP did not reduce all-cause mortality in RCTs of hospitalized COVID-19 patients. Convalescent plasma did not have an effect on other clinical or safety outcomes. Until now there is no good quality evidence to recommend CP for hospitalized COVID-19 patients.


Lung ◽  
2020 ◽  
Vol 198 (5) ◽  
pp. 795-801
Author(s):  
Marlies van Dijk ◽  
Karin Klooster ◽  
Jorine E. Hartman ◽  
Nick H. T. ten Hacken ◽  
Dirk-Jan Slebos

Abstract Background and Purpose In patients with severe emphysema, dynamic hyperinflation is superimposed on top of already existing static hyperinflation. Static hyperinflation reduces significantly after bronchoscopic lung volume reduction (BLVR). In this study, we investigated the effect of BLVR compared to standard of care (SoC) on dynamic hyperinflation. Methods Dynamic hyperinflation was induced by a manually paced tachypnea test (MPT) and was defined by change in inspiratory capacity (IC) measured before and after MPT. Static and dynamic hyperinflation measurements were performed both at baseline and 6 months after BLVR with endobronchial valves or coils (treatment group) or SoC (control group). Results Eighteen patients underwent BLVR (78% female, 57 (43–67) years, FEV1 25(18–37) %predicted, residual volume 231 (182–376) %predicted). Thirteen patients received SoC (100% female, 59 (44–74) years, FEV1 25 (19–37) %predicted, residual volume 225 (152–279) %predicted. The 6 months median change in dynamic hyperinflation in the treatment group was: + 225 ml (range − 113 to + 803) (p < 0.01) vs 0 ml (− 1067 to + 500) in the control group (p = 0.422). An increase in dynamic hyperinflation was significantly associated with a decrease in residual volume (r = − 0.439, p < 0.01). Conclusion Bronchoscopic lung volume reduction increases the ability for dynamic hyperinflation in patients with severe emphysema. We propose this is a consequence of improved static hyperinflation.


2020 ◽  
Author(s):  
Antonio Miguel-Cruz ◽  
Anna-Maria Ladurner ◽  
Megan Kohls-Wiebe ◽  
David Rawani ◽  
Fiona Jaffray

BACKGROUND Mental health is a prevalent condition amongst Canadians. Mental health conditions are the leading cause of disability, as each year 1 in 5 Canadians experiences a mental health issue. Five percent of people aged 65 years and older perceive their mental health as fair or poor, and 6.3% of them have mood disorders. Regarding older adults with cognitive impairments such as dementias, up to 40 to 50 per cent of them experience depression at some point. We believe that older adults can benefit significantly from information and telecommunication technologies (ICTs) as a strategy for improving mental health conditions such as depression and anxiety, while at the same time improving their quality of life. 3Scape Systems Inc. is an Albertan-based private company that has produced a series of specialized 3D videos that have been designed to simulate real-life events and engage individuals living with mental health disorders and cognitive impairments such as dementia. OBJECTIVE The purpose of this study is to explore the trial design and effects of 3Scape videos on older adults’ symptoms of depression, anxiety, and quality of life, as well as the efficacy of this technology in reducing the caregiver burden on the START Psychiatry Day Hospital program at Glenrose Rehabilitation Hospital (GRH), and to provide data in order to estimate the parameters required to design a definitive Randomized Controlled Trial (RCT). METHODS The trial will use a randomized controlled design comprising 15 intervention participants and 15 control group participants. The participants will be adults aged 65 years and older who are cognitively intact or who have a minimal cognitive impairment, i.e. Montreal Cognitive Assessment (MOCA) ≥18), and clients from the START Psychiatry Day Hospital program at GRH. This study’s primary outcome variables are related to the clients’ depressive and anxiety symptoms, and their quality of life. The control group will receive the standard of care (i.e. the START Psychiatry Day Hospital program at GRH). The intervention group will receive the same standard of care as the control group at each facility and will use the 3Scape Systems videos for the therapeutic activities. RESULTS Our study is currently on hold due to the Covid-19 global pandemic. The recruitment process is expected to resume by November 2020 and the primary impact analysis is expected to be conducted by February 2021. CONCLUSIONS This study will provide valuable information such as the measurement of comparative intervention effects, perception of older adults and hand therapists about the 3Scape Systems, the associated costs of treatment, and product costings. This will contribute to the evidence planning process, which will be crucial for the future adoption of the 3Scape Systems. CLINICALTRIAL International Registered Report Identifier (IRRID): ISRCTN: 93685907 (available at https://doi.org/10.1186/ISRCTN93685907)


Open Medicine ◽  
2019 ◽  
Vol 14 (1) ◽  
pp. 271-278 ◽  
Author(s):  
Erxiang Gao ◽  
Chi Zhang ◽  
Jianping Wang

AbstractObjectiveOur objective is to explore the effects of budesonide combined with noninvasive ventilation on procalcitonin (PCT), soluble myeloid cell triggering receptor-1 (sTREM-1), thoracic and lung compliance, humoral immune function, and quality of life in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) complicated with type II respiratory failure.MethodsThere were 82 patients with AECOPD complicated with type II respiratory failure admitted into our hospital between March, 2016-September, 2017. They were selected and randomly divided into observation group (n=41) and control group (n=41). The patients in the control group received noninvasive mechanical ventilation and the patients in the observation group received budesonide based on the control group. The treatment courses were both 10 days.ResultsThe total effective rate in the observation group (90.25%) was higher than the control group (65.85%) (P<0.05). The scores of cough, expectoration, and dyspnea were decreased after treatment (Observation group: t=18.7498, 23.2195, 26.0043, control group: t=19.9456, 11.6261, 14.2881, P<0.05); the scores of cough, expectoration, and dyspnea in the observation group were lower than the control group after treatment (t=11.6205, 17.4139, 11.6484, P<0.05). PaO2 was increased and PaCO2 was decreased in both groups after treatment (Observation group: t=24.1385, 20.7360, control group: t=11.6606, 9.2268, P<0.05); PaO2 was higher and PaCO2 was lower in the observation group than the control group after treatment (t=10.3209, 12.0115, P<0.05). Serum PCT and sTREM-1 in both groups were decreased after treatment (Observation group: t=16.2174, 12.6698, control group: t=7.2283, 6.1634, P<0.05); serum PCT and sTREM-1 in the observation group were lower than the control group after treatment (t=10.1017, 7.8227, P<0.05). The thoracic and lung compliance in both groups were increased after treatment (Observation group: t=30.5359, 17.8471, control group: t=21.2426, 13.0007, P<0.05); the thoracic and lung compliance in the observation group were higher than the control group after treatment (t=10.8079, 5.9464, P<0.05). IgA and IgG in both groups were increased after treatment (Observation group: t=9.5794, 25.3274, control group: t=5.5000, 4.7943, P<0.05), however IgM was not statistically different after treatment (Observation group: t=0.7845, control group: t=0.1767, P>0.05); IgA and IgG in the observation group were higher than the control group (t=4.9190, 4.7943, P<0.05), however IgM was not statistically different between two groups after treatment (t=0.6168, P>0.05). COPD assessment test (CAT) scores were decreased in both groups after treatment (Observation group: t=20.6781, control group: t=9.0235, P<0.05); CAT score in the observation group was lower than the control group after treatment (t=12.9515, P<0.05). Forced expiratory volume in one second (FEV1%) and forced expiratory volume in one second/ forced expiratory volume in one second (FEV1/FVC) were increased in both groups after treatment (Observation group: t=15.3684, 15.9404, control group: t=10.6640, 12.8979, P<0.05); FEV1% and FEV1/FVC in the observation group were higher than the control group (t=6.9528, 7.3527,P<0.05). The rates of complication were not statistically different between two groups (P>0.05).ConclusionBudesonide combined with noninvasive mechanical ventilation has good curative effects in treating AECOPE patients complicated with type II respiratory failure. It can decrease serum PCT and sTREM-1, increase thoracic lung compliance, and improve the humoral immune function and life quality.


2014 ◽  
Vol 44 (4) ◽  
pp. 885-894 ◽  
Author(s):  
Sally L. Wootton ◽  
L.W. Cindy Ng ◽  
Zoe J. McKeough ◽  
Sue Jenkins ◽  
Kylie Hill ◽  
...  

This study was designed to determine the effect of ground-based walking training on health-related quality of life and exercise capacity in people with chronic obstructive pulmonary disease (COPD).People with COPD were randomised to either a walking group that received supervised, ground-based walking training two to three times a week for 8–10 weeks, or a control group that received usual medical care and did not participate in exercise training.130 out of 143 participants (mean±sd age 69±8 years, forced expiratory volume in 1 s 43±15% predicted) completed the study. Compared to the control group, the walking group demonstrated greater improvements in the St George’s Respiratory Questionnaire total score (mean difference -6 points (95% CI -10– -2), p<0.003), Chronic Respiratory Disease Questionnaire total score (mean difference 7 points (95% CI 2–11), p<0.01) and endurance shuttle walk test time (mean difference 208 s (95% CI 104–313), p<0.001).This study shows that ground-based walking training is an effective training modality that improves quality of life and endurance exercise capacity in people with COPD.


2019 ◽  
Vol 1 (2) ◽  
pp. 28-33
Author(s):  
Refi Sulistiasari

It is known that inflammation is the underlying cause of COPD, and this affects to quality of life of the patient. Provision of inhaled therapy combination of LABA and corticosteroids is one of therapy in pharmacology of stable PPOK patients. The aim of this study was to know the benefits of inhalation of 50 mg / fluticasone propionate 500 mg inhibition in stable COPD patients. The research design is clinical trial. The study was conducted for 3 months and was performed on 26 stable COPD patients divided into two groups: 15 patients for the treatment group and 15 patients for the control group. After the measurements were obtained, there was a significant difference in the quality of life as measured by St. George's Respiratory Questionnaire (SGRQ) (p = 0.001) and COPD Assessment Test (CAT) (0.001) measurements were made twice on the first and thirtieth days.


2021 ◽  
Vol 2021 (4) ◽  
pp. 14-20
Author(s):  
Yu. I. Feshchenko ◽  
◽  
L. A. Iashyna ◽  
G. L. Gumeniuk ◽  
V. I. Ignatieva ◽  
...  

THE EFFICACY OF COMBINED THERAPY IN PATIENTS WITH NEUTROPHILIC BRONCHIAL ASTHMA Yu. I. Feshchenko, L. A. Iashyna, G. L. Gumeniuk, V. I. Ignatieva, M. A. Polianska, S. G. Opimakh, I. V. Zvol, S. M. Moskalenko, N. A. Vlasova, L. A. Halai State organization «F. G. Yanovsky National institute of phthisiology and pulmonology National Academy of medical sciences of Ukraine» , Kyiv, Ukraine Abstract. Background: Issues of neutrophilic bronchial asthma remain unresolved and the investigations of the pathogenesis and treatment of this disease endotype are currently continuing. The aim of the study: This study aimed to develop the technology of the treatment of the neutrophilic asthma with the use of available drugs in Ukraine. Methods. The study involved 30 patients with neutrophilic asthma. The first (control) group consisted of 15 patients who received standard therapy with a combination of budesonide and formoterol. The second (main) group consisted of 15 patients who received the treatment according the technology (ultrafine beclomethasone dipropionate, formoterol, tiotropium bromide and additionally for the first 10 days — inhalation of 10.0 % acetylcysteine solution through a nebulizer). All patients were surveyed with the Asthma Control Test (ACT), the Asthma Control Questionnaire (ACQ). The quality of life of patients was assessed by a St. George’s Respiratory Questionnaire. All patients underwent spirometry and a 6-minute walking test (6MWT). Results: In the prescription of complex therapy to patients with neutrophilic asthma clinical and functional efficacy was achieved in 93.3 % of patients. There were observed statistically significant increase in the ACT from (14.3 ± 1.3) to (20.3 ± 0.8) points (p < 0.05), a decrease in the ACQ from (2.3 ± 0.2) ) to (1.1 ± 0.1) points (p < 0.05), clinically significant reduction in the number of symptoms from (71.4 ± 5.6) points to (51.3  5.0) points, p < 0.05 according to the results of the St. George’s Respiratory Questionnaire, and a statistically significant increase in MEF50 from (28.9 ± 4.5) % to (41.6 ± 4.2) %, p < 0.05, MEF25 — from (19.1 ± 2.9) % to (27.6 ± 2.6) %, p < 0.05 and FEV1 /FVC from (67.2 ± 3.5) % to (76.1 ± 2.3) %, p < 0.05 after 3 months of complex treatment, as well as a statistically significant increase in the number of meters passed in the 6MWT from (266.3 ± 16.2) m to (312.0 ± 14.4) m, p < 0.05, reduction of shortness of breath on the Borg scale before test from (2.5  0.3) points to (1.5 ± 0.1) points, p < 0.05 and after the test — from (4.1 ± 0.3) points to (3.1 ± 0.3) points, p < 0.05. Conclusions: The technology of treatment of patients with neutrophilic asthma allows to improve the control of the asthma symptoms and quality of life of the patients, bronchial patency at the small airways and reduce fixed bronchial obstruction, as well as increase exercise tolerance. Key words: bronchial asthma, neutrophilic inflammation, combined therapy.


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