scholarly journals Comparison of Immediate and Sequential Withdrawal of a Systemic Glucocorticoid in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease: A Multicenter, Randomized, Double-Blind, Parallel-Controlled, Open-Label Study

2021 ◽  
Vol 8 ◽  
Author(s):  
Ling Zhou ◽  
Yuanyuan Fang ◽  
Wei Liu ◽  
Jianchu Zhang ◽  
Yingnan Wang ◽  
...  
Keyword(s):  
Acute Exacerbation ◽  
Chronic Obstructive ◽  
Open Label ◽  
Double Blind ◽  
Obstructive Pulmonary Disease ◽  
Open Label Study ◽  
Label Study ◽  
Acute Exacerbations ◽  
Systemic Glucocorticoids

Patients with acute exacerbations of chronic obstructive pulmonary disease (AECOPD) were treated with immediate or sequential withdrawal after 5 days of systemic glucocorticoids. The effects of the two withdrawal methods on the prognosis of patients were compared at 30, 90, 180, and 360 days after discharge. A multicenter, randomized, double-blind, parallel-controlled, open-label study was conducted in the respiratory department of tertiary hospitals in Central China. Patients met inclusion criteria for AECOPD and needed to use systemic glucocorticoids. They were randomly assigned to immediate and sequential withdrawal groups at a 1:1 ratio. The study was completed in August 2020 and is registered at the China Clinical Trials Registry (Chictr.org) (ChiCTR1800018894). According to general data and clinical characteristics, there were no statistically significant differences between the 329 patients in the immediate withdrawal group and the 310 patients in the sequential withdrawal group (P > 0.05). At the 30, 90, 180, and 360-days follow-up, the acute exacerbation frequency, rehospitalization rate, mortality, and intensive care unit (ICU) treatment rate were not significantly different between the immediate withdrawal group and sequential withdrawal group (P > 0.05). The modified Medical Research Council (mMRC) and COPD assessment test (CAT) scores were also not significantly different between the two groups. At the 180- and 360-day follow-up, forced expiratory volume in 1 s (FEV1%) and peak expiratory flow (PEF) were not significantly different between the two groups (P > 0.05). The time from discharge to first acute exacerbation was significantly lower in the immediate withdrawal group (46.12 days) than in sequential withdrawal group (49.02 days) (P < 0.05). The time of stay in the hospital for the first time after discharge was not significantly different between the two groups (P > 0.05). Adverse events were not significantly different between the immediate withdrawal group and sequential withdrawal group (P < 0.05). Subgroup analysis was performed according to age, degree of disease, and relevant indicators. At the 30-day follow-up, the acute exacerbation frequency of patients with advanced age, high global strategy for chronic obstructive lung disease (GOLD), and high fractional exhaled nitric oxide was significantly higher in the immediate withdrawal group than in the sequential withdrawal group (P < 0.05). In addition, according to receiver operating characteristic (ROC) curve analysis, the frequency of acute exacerbations at the 30-day follow-up was significantly higher in patients with age > 63.5 years or GOLD > 3 in the immediate withdrawal group than in the sequential withdrawal group, suggesting that the short-term efficacy was poor.

scholarly journals Tasimelteon safely and effectively improves sleep in Smith–Magenis syndrome: a double-blind randomized trial followed by an open-label extension

2021 ◽  
Author(s):  
Christos M. Polymeropoulos ◽  
Justin Brooks ◽  
Emily L. Czeisler ◽  
Michaela A. Fisher ◽  
Mary M. Gibson ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Crossover Study ◽  
Total Sleep Time ◽  
Sleep Time ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Sleep Complaints ◽  
Open Label Extension

Abstract Purpose To assess the efficacy of tasimelteon to improve sleep in Smith–Magenis syndrome (SMS). Methods A 9-week, double-blind, randomized, two-period crossover study was conducted at four US clinical centers. Genetically confirmed patients with SMS, aged 3 to 39, with sleep complaints participated in the study. Patients were assigned to treatment with tasimelteon or placebo in a 4-week crossover study with a 1-week washout between treatments. Eligible patients participated in an open-label study and were followed for >3 months. Results Improvement of sleep quality (DDSQ50) and total sleep time (DDTST50) on the worst 50% of nights were primary endpoints. Secondary measures included actigraphy and behavioral parameters. Over three years, 52 patients were screened, and 25 patients completed the randomized portion of the study. DDSQ50 significantly improved over placebo (0.4, p = 0.0139), and DDTST50 also improved (18.5 minutes, p = 0.0556). Average sleep quality (0.3, p = 0.0155) and actigraphy-based total sleep time (21.1 minutes, p = 0.0134) improved significantly, consistent with the primary outcomes. Patients treated for ≥90 days in the open-label study showed persistent efficacy. Adverse events were similar between placebo and tasimelteon. Conclusion Tasimelteon safely and effectively improved sleep in SMS.

scholarly journals Combination antibiotic therapy versus monotherapy in the treatment of acute exacerbations of chronic obstructive pulmonary disease: an open-label randomized trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Phuong Nguyen Thi Thu ◽  
Minh Ngo Thị Huong ◽  
Ngan Tran Thi ◽  
Hoi Nguyen Thanh ◽  
Khue Pham Minh
Keyword(s):  
Clinical Success ◽  
Chronic Obstructive ◽  
Gram Negative Bacteria ◽  
Beta Lactam ◽  
Open Label ◽  
Obstructive Pulmonary Disease ◽  
Gram Negative ◽  
Copd Exacerbations ◽  
Beta Lactam Antibiotics ◽  
Acute Exacerbations

Abstract Background The role of antibiotics in the treatment of chronic obstructive pulmonary disease (COPD) exacerbations and their effectiveness in combination have not been clearly established. To determine whether using a combination of fluoroquinolones and beta-lactams improves the clinical and microbiological efficacy of antibiotics on day 20 of treatment, we conducted an open-label randomized trial based on clinical outcomes, microbiological clearance, spirometry tests, and signs of systemic inflammation in patients hospitalized with acute exacerbations of COPD. Methods We enrolled 139 subjects with COPD exacerbations, defined as acute worsening of respiratory symptoms leading to additional treatment. Patients were divided randomly into two groups: 79 patients using beta-lactam antibiotics alone and 60 using beta-lactam antibiotics plus fluoroquinolones. Clinical and microbiological responses, spirometry tests, symptom scores, and serum C-reactive protein (CRP) levels were evaluated. Results Clinical success, lung function, and symptoms were similar in patients with or without fluoroquinolone administration on days 10 and 20. Combination therapy was superior in terms of microbiological outcomes and reduction in serum CRP value. Although equivalent to monotherapy in terms of clinical success, the combination showed superiority in terms of microbiological success and a decrease in CRP. The combination therapy group had a higher microbiological success rate with gram-negative bacteria than the monotherapy group with Pseudomonas aeruginosa (100% vs. 33.3%, respectively) and Acinetobacter baumanii (100% vs. 20%, respectively) (P < 0.05). Conclusions Concomitant use of fluoroquinolone and beta-lactam antibiotics for bacterial infections during COPD exacerbations caused by gram-negative bacteria appear to be effective and should be applied in clinical practice.

Microalbuminuria on admission for acute exacerbation of COPD as a predictor of all-cause mortality and future exacerbations

2021 ◽  
pp. postgradmedj-2021-141206
Author(s):  
Konstantinos Bartziokas ◽  
Christos Kyriakopoulos ◽  
Evangelia Dounousi ◽  
Konstantinos Kostikas
Keyword(s):  
Acute Exacerbation ◽  
Chronic Obstructive Lung Disease ◽  
Multivariate Regression Analysis ◽  
Forced Expiratory Volume ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Acute Exacerbation Of Copd ◽  
Tertiary Hospitals ◽  
Exacerbation Of Copd

ObjectivesMicroalbuminuria (MAB) is a sensitive biomarker of cardiovascular risk that is directly associated with cardiovascular events and mortality. Recent studies have evaluated the presence of MAB in patients with stable chronic obstructive pulmonary disease (COPD) or hospitalised for acute exacerbation of COPD (AECOPD).MethodsWe evaluated 320 patients admitted for AECOPD in respiratory medicine departments of two tertiary hospitals. On admission, demographic, clinical and laboratory values and COPD severity were assessed. Patients were evaluated monthly for 1 year, recording new AECOPD and death from any cause.ResultsPatients with documented MAB (urinary albumin excretion of 30–300 mg/24 hours) on admission had worse lung function (forced expiratory volume in 1 s, %) (mean (SD) 34.2 (13.6)% vs 61.5 (16.7)%), higher modified Medical Research Council (3.6 (1.2) vs 2.1 (0.8)), lower 6 min walk test (171 (63) vs 366 (104)) and more hospitalisation days (9 (2.8) vs 4.7 (1.9)) (p<0.001 for all comparisons). MAB was also correlated with Global Initiative for Chronic Obstructive Lung Disease 2020 COPD stages (p<0.001). In multivariate regression analysis, MAB was a significant predictor of longer hospitalisation duration (OR 6.847, 95% CI 3.050 to 15.370, p<0.0001). Twelve-month follow-up revealed that patients with MAB experienced more AECOPDs (4.6 (3.6) vs 2.2 (3.5), p<0.0001) and deaths, n (%) (52 (36.6) vs 14 (7.8), p<0.001). Kaplan-Meier survival curves demonstrated that patients with MAB presented with increased mortality, AECOPD and hospitalisation for AECOPD risk at 1 year (p<0.001 for all comparisons).ConclusionsThe presence of MAB on admission for AECOPD was associated with more severe COPD and prolonged hospitalisation, as well as with higher rates of AECOPD and mortality risk at 1-year follow-up.

Sign in / Sign up

Export Citation Format

Share Document